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| ID | Type | Description | Link |
|---|---|---|---|
| 07-C-0195 |
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Background:
Major problems with stem cell transplantation (SCT) for cancer treatment are a lack of suitable donors for patients without a human leukocyte-antigen (HLA) tissue-matched sibling and graft-versus-host disease (GVHD), a serious side effects of immune-suppressing chemotherapy that is given to bring the cancer under control before SCT. In GVHD, the patients immune system attacks the transplanted donor cells.
This study will try to improve the results of SCT from unrelated HLA-matched donors using targeted immune-depleting chemotherapy to bring the cancer under control before transplantation and to lower the chance of graft rejection, followed by reduced-intensity transplant chemotherapy to make the procedure less toxic.
Objectives:
To evaluate the safety and effectiveness of targeted immune-depleting chemotherapy followed by reduced-intensity transplant chemotherapy in patients with advanced cancers of the blood and immune system.
To evaluate the safety and effectiveness of two different drug combinations to prevent GVHD. Both regimens have been successful in preventing GVHD, but they work by different mechanisms and affect the rebuilding of the immune system after the transplant.
Eligibility:
People 18 to 74 years of age with advanced or high-risk cancers of the blood and immune system who do not have a suitable HLA-matched sibling.
Design:
All patients receive chemotherapy before transplant to treat the cancer and suppress immune function.
All patients receive a conditioning regimen of cyclophosphamide for 4 days and fludarabine for 4 days before SCT to prepare for the transplant.
Patients are randomly assigned to one of two combination drug treatments to prevent GHVD as follows:
Patients receive the donors stem cells and immune cells 2 days after completing the conditioning regimen.
Patients are followed at the clinic regularly for the first 6 months after SCT, and then less often for at least 5 years. Some visits may include bone marrow aspirates and biopsies, blood draws, and other tests to monitor disease status.
A skin biopsy, oral mucosa biopsy, and saliva collection are done to study chronic GVHD.
...
Background:
Objectives:
Primary objectives:
Secondary objectives include further assessment of immune reconstitution, study of engraftment kinetics, and assessment of those patients who receive higher doses of anthracyclines for long and short term toxicities
Eligibility:
Design:
Patients will receive disease-specific induction chemotherapy (etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (EPOCH-fludarabine (F)/rituximab (R) or fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG)) prior to transplant for disease control and immune depletion. If disease is controlled (greater than partial response (PR)) and immune depletion objectives have been met, patients may forgo induction chemotherapy and move forward to the transplant conditioning regimen.
All patients will receive an identical conditioning regimen consisting of cyclophosphamide 1200 mg/m(2)/day intravenous (IV) for 4 days and fludarabine 30 mg/m(2)/day for 4 days.
Patients will be stratified according to degree of HLA-match and randomized at the time of enrollment to one of two GHVD prophylaxis regimens:
A maximum of 105 patients will be enrolled and randomly assigned to the two arms in order to yield 44 patients per arm (88 total patients) who are able to be evaluated for development of severe chronic GVHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Tacrolimus, methotrexate, sirolimus (TMS) Arm | Experimental | TMS Arm |
|
| B - Cyclosporine (AC) Arm | Experimental | AC Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | Rituximab: 375 mg/m(2) intravenous (IV), day 1 for patients with cluster of differentiation 20 (CD20)-positive disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD) | Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria. | 6 months |
| Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD) | Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. First the individual organ scoring is done, and then based on that the Global score is determined (mild-moderate-severe). See Citation: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. | 2 years post transplant |
| Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells | The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry. | Recipient recovery at 6, 12 and 24 months post transplant |
| Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells | The percentage of CCR7+CD45RA+ naïve T cells within the CD4 and CD8 T cell populations was determined by flow cytometry. | Recipient recovery at 6, 12 and 24 months post transplant |
| Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire | Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD) | Acute GVHD is assessed by the 1994 Consensus Conference on acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria. | 6 months |
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EXCLUSION CRITERIA RECIPIENT ON STANDARD CARE THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Z Pavletic, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16503494 | Background | Pavletic SZ, Martin P, Lee SJ, Mitchell S, Jacobsohn D, Cowen EW, Turner ML, Akpek G, Gilman A, McDonald G, Schubert M, Berger A, Bross P, Chien JW, Couriel D, Dunn JP, Fall-Dickson J, Farrell A, Flowers ME, Greinix H, Hirschfeld S, Gerber L, Kim S, Knobler R, Lachenbruch PA, Miller FW, Mittleman B, Papadopoulos E, Parsons SK, Przepiorka D, Robinson M, Ward M, Reeve B, Rider LG, Shulman H, Schultz KR, Weisdorf D, Vogelsang GB; Response Criteria Working Group. Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group report. Biol Blood Marrow Transplant. 2006 Mar;12(3):252-66. doi: 10.1016/j.bbmt.2006.01.008. | |
| 23689118 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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There were 89 participants in the study. 3 patients enrolled and their cancers progressed prior to randomization so they were taken off study. 3 of these participants went back into remission with additional chemo and were re-enrolled on the protocol and randomized. They are counted twice in the enrolment (e.g. 92) but only once in the Started row.
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| ID | Title | Description |
|---|---|---|
| FG000 | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 14, 2018 |
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| Cyclosporine | Drug | Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if graft versus host disease (GVHD) does not develop. |
|
|
| Allogenic stem cell transplant (ASCT) | Drug | Allogenic stem cell transplant |
|
| Conditioning Chemotherapy | Drug | Fludarabine:30 mg/m(2) per day IV infusion over 30 minutes, daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m(2) per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m(2) per day IV infusion, Daily on days 6, -5,-4, and -3 |
|
| TMS | Drug | Tacrolimus: starting day -3 before transplant, given initially at 0.02 mg/kg/day CIV. Continue IV and then switch to an equivalent oral dose (when patient taking po) titrated for a goal level of 5 to 10 ng/ml; Sirolimus: given as an initial loading dose of 12 mg p.o. on day -3 pre-transplant, 4 mg starting day -2 pre-transplant and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post-transplant. Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-transplant as tolerated. |
|
|
| FLAG | Drug | Fludarabine:25 mg/m(2) per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m(2) IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day subcutaneous (SC) beginning 24 hours PRIOR to initiation of chemotherapy |
|
|
| EPOCH-F | Drug | Fludarabine:25 mg/m(2) per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m(2) per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m(2)/day CIV, days 1-4 Vincristine:0.4 mg/m(2) per day continuous IV infusion over 24 hours daily on days 1-4 Cyclophosphamide:750 mg/m(2) IV infusion over 30 minutes on day 5 |
|
| Alemtuzumab | Biological | Alemtuzumab:20 mg/day IV over 8 h on days 8 to 4 pre-transplant. |
|
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| Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant |
| Changes in CD8 T Cell Receptor Vbeta Repertoire | Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison. | Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant |
| Toxicities |
Here are the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. |
| 103 months and 22 days |
| Days to Engraftment of Neutrophils | Days to engraftment is defined as neutrophil recovery: designated by the first of 3 consecutive days with an absolute neutrophil count (ANC) above 500/mm(3). | 2 years |
| Days to Engraftment of Platelets | Platelet recovery: designated by the first of 7 days where the platelet count remains above 20,000/mm(3) without transfusion support | 2 years |
| Days to Engraftment of Lymphocytes | Lymphocyte recovery: designated by the first of 3 consecutive days with absolute lymphocyte count (ALC) above 500/mm(3). | 2 years |
| Overall Survival | Time between the first day of transplant to the day of death. | Patients were followed for an average of up to 5 years. |
| Early Treatment Related Mortality | Any death occurring within 28 days after transplantation in a patient in continuous remission. | Less than or equal to 28 days after transplantation |
| Percentage of Participants With Late Treatment Related Mortality | Any death occurring 28 days or more after transplantation in a patient in continuous remission. | Greater than 28 days after transplantation |
| Decline in Homeostatic Cytokine Interleukin 7 (IL-7) Post-Transplant | During depletion of lymphocytes during transplant conditioning, levels of homeostatic cytokines increase in the blood. These then decline with the expansion of new donor-derived cells. The rapidity of decline may predict acute graft versus host disease (AGVHD). Decline in cytokine IL-7 will be assessed by the enzyme-linked immunosorbent assay (ELISA). | Day 0, 1 week and 2 weeks |
| Immune Reconstitution of Normal Killer (NK) Cells | Cluster of differentiation 3 (CD3) - cluster of differentiation 56 (CD56) + Natural Killer (NK) cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. | 2 weeks, and 1, 3, 6, 12, and 24 months post transplant |
| Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations | Cluster of Differentiation 3 (CD3)+CD4+ and CD3+Cluster of Differentiation 8 (CD8)+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. | 2 weeks, and 1, 3, 6, 12 and 24 months post transplant |
| Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations | Cluster of differentiation 3 (CD3)+cluster of differentiation 4 (CD4)+ and CD3+CD8+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. | 2 weeks, 1, 3, 6, 12 and 24 months post transplant |
| Background |
| Shaffer BC, Modric M, Stetler-Stevenson M, Arthur DC, Steinberg SM, Liewehr DJ, Fowler DH, Gale RP, Bishop MR, Pavletic SZ. Rapid complete donor lymphoid chimerism and graft-versus-leukemia effect are important in early control of chronic lymphocytic leukemia. Exp Hematol. 2013 Sep;41(9):772-8. doi: 10.1016/j.exphem.2013.04.015. Epub 2013 May 18. |
| 16980994 | Background | Pavletic SZ, Lee SJ, Socie G, Vogelsang G. Chronic graft-versus-host disease: implications of the National Institutes of Health consensus development project on criteria for clinical trials. Bone Marrow Transplant. 2006 Nov;38(10):645-51. doi: 10.1038/sj.bmt.1705490. Epub 2006 Sep 18. |
| 22289893 | Background | Hardy NM, Fellowes V, Rose JJ, Odom J, Pittaluga S, Steinberg SM, Blacklock-Schuver B, Avila DN, Memon S, Kurlander RJ, Khuu HM, Stetler-Stevenson M, Mena E, Dwyer AJ, Levine BL, June CH, Reshef R, Vonderheide RH, Gress RE, Fowler DH, Hakim FT, Bishop MR. Costimulated tumor-infiltrating lymphocytes are a feasible and safe alternative donor cell therapy for relapse after allogeneic stem cell transplantation. Blood. 2012 Mar 22;119(12):2956-9. doi: 10.1182/blood-2011-09-378398. Epub 2012 Jan 30. |
| 38669315 | Derived | Holtzman NG, Curtis LM, Salit RB, Shaffer BC, Pirsl F, Ostojic A, Steinberg SM, Schulz E, Wilder JS, Hughes TE, Rose J, Memon S, Korngold R, Gea-Banacloche JC, Fowler DH, Hakim FT, Gress RE, Bishop MR, Pavletic SZ. High-dose alemtuzumab and cyclosporine vs tacrolimus, methotrexate, and sirolimus for chronic graft-versus-host disease prevention. Blood Adv. 2024 Aug 27;8(16):4294-4310. doi: 10.1182/bloodadvances.2023010973. |
| 32785680 | Derived | Assmann JC, Farthing DE, Saito K, Maglakelidze N, Oliver B, Warrick KA, Sourbier C, Ricketts CJ, Meyer TJ, Pavletic SZ, Linehan WM, Krishna MC, Gress RE, Buxbaum NP. Glycolytic metabolism of pathogenic T cells enables early detection of GVHD by 13C-MRI. Blood. 2021 Jan 7;137(1):126-137. doi: 10.1182/blood.2020005770. |
| FG001 | B - Cyclosporine (AC) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
| COMPLETED |
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| NOT COMPLETED |
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There were 89 participants in the study. 3 patients enrolled and their cancers progressed prior to randomization so they were taken off study. 3 of these participants went back into remission with additional chemo and were re-enrolled on the protocol and randomized. They are counted twice in the enrolment (e.g. 92) but only once in the Started row.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | Rituximab:375 mg/m2 IV, day 1 for patients with CD20-positive disease. Allogenic stem cell transplant (ASCT):Conditioning Chemotherapy:Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3.Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3.Tacrolimus: 0.02 mg/kg, start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated. Methotrexate: 5mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop.FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5. Cytarabine: 2,000 mg/m2 IV over 4 hours, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy |
| BG001 | Cyclosporine (AC) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Histology | Acute Myeloid Leukemia (AML)/Myelodysplastic Syndrome (MDS); Cutaneous T Cell Lymphoma (CTCL)/Peripheral T Cell Lymphoma (PTCL) | Count of Participants | Participants | No |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Grade II-IV Acute Graft Versus Host Disease (GVHD) | Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Primary | Percentage of Participants With Chronic Graft Versus Host Disease (cGVHD) | Chronic GVHD is assessed by the 2005 Chronic GVHD Consensus Project. First the individual organ scoring is done, and then based on that the Global score is determined (mild-moderate-severe). See Citation: Filipovich AH, Weisdorf D, Pavletic S, et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005; 11:945-56., for grading criteria. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years post transplant |
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| Primary | Recovery of Naïve Cluster of Differentiation 4 (CD4) T Cells | The percentage of C-C motif chemokine receptor 7 (CCR7)+CD45RA+ naïve T cells within the CD4 T cell populations was determined by flow cytometry. | A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study. | Posted | Median | Full Range | % of naive (CCR7+CD45RA+) CD4 Cells | Recipient recovery at 6, 12 and 24 months post transplant |
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| Primary | Recovery of Naïve Cluster of Differentiation 8 (CD8) T Cells | The percentage of CCR7+CD45RA+ naïve T cells within the CD4 and CD8 T cell populations was determined by flow cytometry. | A few measurements were missed, one patient was not evaluable for technical reasons and removed from the analysis, but most of the decline was due to patients that had gone off study. | Posted | Median | Full Range | % of naive (CCR7+CD45RA+) CD8 Cells | Recipient recovery at 6, 12 and 24 months post transplant |
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| Primary | Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire | Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison. | The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available. | Posted | Median | Full Range | Divergence index | Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant |
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| Primary | Changes in CD8 T Cell Receptor Vbeta Repertoire | Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison. | The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available. | Posted | Median | Full Range | Divergence index | Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant |
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| Secondary | Percentage of Participants With Grade III-IV Acute Graft Versus Host Disease (GVHD) | Acute GVHD is assessed by the 1994 Consensus Conference on acute GVHD Grading criteria. See Przepiorka D, Weisdorf D, Martin P, et al. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995; 15:825-8., for grading criteria. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 months |
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| Secondary | Toxicities | Here are the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. | Posted | Number | participants | 103 months and 22 days |
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| Secondary | Days to Engraftment of Neutrophils | Days to engraftment is defined as neutrophil recovery: designated by the first of 3 consecutive days with an absolute neutrophil count (ANC) above 500/mm(3). | One myeloma patient had graft failure in the AC Arm. 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Median | Full Range | Days to neutrophil engraftment | 2 years |
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| Secondary | Days to Engraftment of Platelets | Platelet recovery: designated by the first of 7 days where the platelet count remains above 20,000/mm(3) without transfusion support | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Median | Full Range | Days | 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Days to Engraftment of Lymphocytes | Lymphocyte recovery: designated by the first of 3 consecutive days with absolute lymphocyte count (ALC) above 500/mm(3). | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Median | Full Range | Days | 2 years |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Time between the first day of transplant to the day of death. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Median | 95% Confidence Interval | Months | Patients were followed for an average of up to 5 years. |
| ||||||||||||||||||||||||||||||
| Secondary | Early Treatment Related Mortality | Any death occurring within 28 days after transplantation in a patient in continuous remission. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Number | participants | Less than or equal to 28 days after transplantation |
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Late Treatment Related Mortality | Any death occurring 28 days or more after transplantation in a patient in continuous remission. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. | Posted | Number | 95% Confidence Interval | percentage of participants | Greater than 28 days after transplantation |
| ||||||||||||||||||||||||||||||
| Secondary | Decline in Homeostatic Cytokine Interleukin 7 (IL-7) Post-Transplant | During depletion of lymphocytes during transplant conditioning, levels of homeostatic cytokines increase in the blood. These then decline with the expansion of new donor-derived cells. The rapidity of decline may predict acute graft versus host disease (AGVHD). Decline in cytokine IL-7 will be assessed by the enzyme-linked immunosorbent assay (ELISA). | Following the focus on chronic graft-versus host disease (GVHD) as a primary outcome measure in 2011, this measure was not assessed. | Posted | Day 0, 1 week and 2 weeks |
| |||||||||||||||||||||||||||||||||
| Secondary | Immune Reconstitution of Normal Killer (NK) Cells | Cluster of differentiation 3 (CD3) - cluster of differentiation 56 (CD56) + Natural Killer (NK) cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated. | Posted | Median | Full Range | Cells/µl | 2 weeks, and 1, 3, 6, 12, and 24 months post transplant |
| ||||||||||||||||||||||||||||||
| Secondary | Immune Reconstitution of Cluster of Differentiation 4 (CD4) T Cell Populations | Cluster of Differentiation 3 (CD3)+CD4+ and CD3+Cluster of Differentiation 8 (CD8)+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated. | Posted | Median | Full Range | Cells/µl | 2 weeks, and 1, 3, 6, 12 and 24 months post transplant |
| ||||||||||||||||||||||||||||||
| Secondary | Immune Reconstitution of Cluster of Differentiation 8 (CD8) T Cell Populations | Cluster of differentiation 3 (CD3)+cluster of differentiation 4 (CD4)+ and CD3+CD8+ T cells within the lymphocyte population were determined by flow cytometry. The absolute numbers of cells/µl were calculated from the absolute lymphocyte count. | 2 of 44 patients who completed the AC arm were transplanted after our cutoff for data analysis and are not included. A total of 5 completed participants did not contribute data due to missing samples, and participants who died and were not able to supply samples for the time points indicated. | Posted | Median | Full Range | Cells/µl | 2 weeks, 1, 3, 6, 12 and 24 months post transplant |
|
103 months and 22 days
One participant was enrolled and given induction chemotherapy but was never randomized to Arm TMS or AC. Subject had one AE (infection with normal ANC or Grade 1 or 2 neutrophils: Pharynx). Subject was taken off study for disease progression and died.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | TMS Arm Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 TMS: Tacrolimus: 0.02 mg/kg , start day 3. Continue IV or PO. Taper will begin at day +63 if no acute GVHD then at day +119 and discontinue at day +180 as tolerated Methotrexate: 5 mg/m2 IV over 15 minutes on days 1, 3, 6, and 11. Sirolimus: 12 mg PO on days -3 to 63, followed by a taper if GVHD does not develop. FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy | 8 | 44 | 36 | 44 | 43 | 44 |
| EG001 | B - Cyclosporine (AC) Arm | AC Arm Rituximab: Rituximab: 375 mg/m2 IV, day 1 for patients with CD20-positive disease Cyclosporine: Cyclosporine: IV over 2 hours or orally every 12 hours on days -1 to 100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant (ASCT): Allogenic stem cell transplant Conditioning Chemotherapy: Fludarabine:30 mg/m2 per day IV infusion over 30 minutes, daily On days -6, -5, -4, and -3 Cyclophosphamide:1200 mg/m2 per day IV infusion over 2 hours on Days 6, -5, -4, -3 Mesna: 1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3 FLAG: Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5 Cytarabine: 2,000 mg/m2 IV over 4 hours,on Days 1, 2, 3, 4, 5 Filgrastim: 5 mcg/kg per day SC beginning 24 hours PRIOR to initiation of chemotherapy EPOCH-F: Fludarabine:25 mg/m2 per day IV infusion over 30 minutes, daily on days 1-4 Etoposide :50 mg/m2 per day continuous IV infusion over 24 hours on days 1-4 Doxorubicin:10 mg/m2/d | 19 | 45 | 41 | 45 | 42 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ataxia (incoordination) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Carbon monoxide diffusion capacity (DL(co)) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiopulmonary arrest, cause unknown (non-fatal) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cytokine release syndrome/acute infusion reaction | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term::Death NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term::Disease progression NOS | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Death not associated with CTCAE term::Multi-organ failure | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology/Skin - Other (Deep sclerosis per MRI, GVHD possible) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: viscera | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, CNS | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Duodenum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Lower GI NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Upper GI NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory::Lung | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory::Nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection:: Abdomen NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L):: |
|
| Infection ::Bladder (urinary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Lip/perioral | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Meninges (meningitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Muscle (infection myositis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Nose | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Rectum | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Trachea | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection - Other | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (S. Aureus positive blood; gram-neg-rod; line infection) |
|
| Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Brain (encephalitis, infectious) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Colon | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Esophagus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Heart (endocarditis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Liver | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Meninges (meningitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Colon | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Iron overload | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Left ventricular diastolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukoencephalopathy (radiographic findings) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic)::Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Right-sided | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | (sclerodermic & fascial changes; leg cramping/edema possible GVHD, prednisone started) |
|
| Myositis (inflammation/damage of muscle) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ocular/Visual - Other | Eye disorders | CTCAE (3.0) | Systematic Assessment | (idiopathic progressive retinal vasculitis; poss inflammatory process; uk etiology; total blindness) |
|
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pancreatic endocrine: glucose intolerance | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Perforation, GI::Small bowel NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (Specify, respiratory failure) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (pleural thickening) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (AKI, required CVVH) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Right ventricular dysfunction (cor pulmonale) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment (AML); | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment | possibly related to cancer treatment (PTLD(liver biopsy + 10/3/08, stomach bx 10/6/08), EBV associated; to cancer treatment (EBV associated PTLD, neck LN bx (+)10/12/11;to cancer treatment (EBV assoc. PTLD;tonsil bx 10/12/11;obstructing nasopharynx). |
|
| Secondary Malignancy - possibly related to cancer treatment (metastat. test cancer in lung) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Stricture/stenosis (including anastomotic), GI::Esophagus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) |
|
| Tumor lysis syndrome | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ulcer, GI::Duodenum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ventricular arrhythmia::Ventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight gain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Alkalosis (metabolic or respiratory) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Amylase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| CPK (creatine phosphokinase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Carbon monoxide diffusion capacity (DL(co)) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac General - Other (cardimyopathy) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac General - Other (heart failure, fluid overload) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac ischemia/infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Colitis, infectious (e.g., Clostridium difficile) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology/Skin - Other (GVHD; cGVHD) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dermatology/Skin - Other (MRSA abscess) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: head and neck | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| FEV(1) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Fibrinogen | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fistula, GI::Anus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| GGT (gamma-Glutamyl transpeptidase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal - Other (GVHD) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal - Other | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | (duodenal bx 1/24/11; very rare apoptotic cells CMV stains (-); steroids started for GVHD) |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Anus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GI::Lower GI NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU::Bladder | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemorrhage, GU::Urinary NOS | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Induration/fibrosis (skin and subcutaneous tissue) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Abdomen NOS |
|
| Infection ::Bladder (urinary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Brain (encephalitis, infectious) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Brain + Spinal cord (encephalomyelitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Colon | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Eye NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Lip/perioral | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Oral cavity-gums (gingivitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L):: |
|
| Infection::Skin (cellulites) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Soft tissue NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L |
|
| Infection ::Upper aerodigestive NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection:: Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection::Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection ::Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) |
|
| Infection - Other (CMV reactivation) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (Rhinovirus, Coronavirus HKU1) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (Varicella zoster; noravirus) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (acinetobacter) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection - Other (dissiminated HSV) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Bladder (urinary) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Colon | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Conjunctiva | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Eye NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Nose | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Paranasal | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Penis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Pharynx | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Stomach | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Trachea | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Upper aerodigestive NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Vagina | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with normal ANC or Grade 1 or 2 neutrophils::Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Bronchus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Catheter-related | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Lung (pneumonia) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Skin (cellulites) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Upper aerodigestive NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Upper airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Infection with unknown ANC::Wound | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Iron overload | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Joint-function | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Left ventricular systolic dysfunction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Leukoencephalopathy (radiographic findings) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lipase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Liver dysfunction/failure (clinical) | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory - Other (pancytopenia; steroid induced hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration::Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration::Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam)::Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic)::Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy)::Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neurology - Other (delirium) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Obstruction, GU::Bladder | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Opportunistic infection associated with >=Grade 2 Lymphopenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Osteonecrosis (avascular necrosis) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Anus | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Throat/pharynx/larynx | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain::Urethra | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pancreatic endocrine: glucose intolerance | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Perforation, GI::Small bowel NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pericardial effusion (non-malignant) | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phlebitis (including superficial thrombosis) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Prolonged QTc interval | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Psychosis (hallucinations/delusions) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other (infiltrates) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Infiltrates; fungal pneumonia |
|
| Pulmonary/Upper Respiratory - Other (infiltrates; fungal pneumonia) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (acute renal injury) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | dysuria; hematuria; stent replacement; fluid overload refractory to normal doses of Lasix |
|
| Renal/Genitourinary - Other (dysuria) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (dysuria; hematuria; stent replacement) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (failure; hematuria; insufficiency; dysuria) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (fluid overload refractory to normal doses of Lasix) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (hematuria) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal/Genitourinary - Other (insufficiency) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Right ventricular dysfunction (cor pulmonale) | Congenital, familial and genetic disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment (mucoepidermoid carcinoma) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Secondary Malignancy - possibly related to cancer treatment (squamous cell carcinoma lip) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Skin breakdown/decubitus ulcer | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia::Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Syndromes - Other (septic shock) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombotic microangiopathy | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | (e.g., thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) |
|
| Thyroid function, low (hypothyroidism) | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal dryness | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vaginal mucositis | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Wound complication, non-infectious | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven Z. Pavletic | National Cancer Institute | 301- 402-4899 | sp326h@nih.gov |
| Feb 11, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 29, 2018 | Feb 11, 2019 | ICF_001.pdf |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D006689 | Hodgkin Disease |
| D009101 | Multiple Myeloma |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D016572 | Cyclosporine |
| D016559 | Tacrolimus |
| D000069585 | Filgrastim |
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D001685 | Biological Factors |
| D061067 | Antibodies, Monoclonal, Humanized |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Hodgkin's Lymphoma (HL) |
|
| Chroni Lymphocytic Leukemia (CLL) |
|
| AML/MDS |
|
| Chronic Myeloid Leukemia (CML) |
|
| CTCL/PTCL |
|
| Acute Lymphoblastic Leukemia (ALL) |
|
| Multiple Myeloma (MM) |
|
| Other |
|
| OG001 | B - Cyclosporine (AC) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
| B - Cyclosporine (AC) Arm |
Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
| B - Cyclosporine (AC) Arm |
Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
| OG001 | B - Cyclosporine (AC) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
| OG001 | B - Cyclosporine (AC) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
| B - Cyclosporine (AC) Arm |
Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
|
|
Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
|
|
|
|
|
|
|
|
Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
|
|
| OG001 | B - Cyclosporine (C) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
| OG001 | B - Cyclosporine (AC) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
| OG001 | B - Cyclosporine (AC) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
|
|
| OG001 | B - Cyclosporine (AC) Arm | Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months. |
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