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| ID | Type | Description | Link |
|---|---|---|---|
| FHCRC-2012.00 | Other Identifier | FHCRC Protocol Number | |
| CDR0000597623 | Registry Identifier | PDQ | |
| T32CA009515 | U.S. NIH Grant/Contract | View source |
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A new protocol was developed to replace this protocol in 2008, with removal of ATG and extension of MMF duration.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
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RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor umbilical cord blood transplant with reduced intensity conditioning works in treating patients with advanced hematological cancer or other disease.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to disease status and prior therapy (hematologic malignancy or other disease that was treated with an autologous stem cell transplant or ≥ 2 courses of multiagent chemotherapy within the past 3 months vs hematologic malignancy or other disease that was treated with an autologous stem cell transplant > 12 months ago or with ≤ 1 course of multiagent chemotherapy or immunosuppressive chemotherapy within the past 3 months vs refractory leukemia or lymphoma for which patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy).
After completion of study treatment, patients are followed at 6 months and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclophosphamide/Fludarabine/TBI | Experimental | Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months. Refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy. |
|
| Cyclophosphamide/Fludarabine/TBI/ATG | Experimental | Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-thymocyte globulin | Biological | 30mg/Kg Days -6 to -4 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Survival at 1 Year | Kaplan-Meier estimate of the probability of survival at 1 year | 1 year post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of Survival at 2 Years | Kaplan-Meier estimate of the probability of survival at 2 years | 2 years post transplant |
| Incidence of Non-relapse Mortality at 6 Months | Number of Participants with Non-relapse Mortality at 6 Months |
Not provided
DISEASE CHARACTERISTICS:
Diagnosis of advanced hematologic malignancy or other disease not curable by conventional chemotherapy, including any of the following:
Acute myeloid leukemia in complete remission (CR)* (as defined by hematologic recovery, < 5% blasts in the bone marrow by morphology, and a cellularity of > 15%), meeting one of the following criteria:
In first complete remission (CR1) AND has high-risk disease as evidenced by any of the following:
In second CR (CR2) or beyond
Acute lymphoblastic leukemia in CR* (as defined by hematologic recovery, < 5% blasts in the bone marrow by morphology, and a cellularity of > 15%), meeting one of the following criteria:
In CR1 AND has high-risk disease as evidenced by any of the following:
Beyond CR2
Chronic myelogenous leukemia (CML)
MDS
Large cell lymphoma, Hodgkin lymphoma, or multiple myeloma, meeting one of the following criteria:
Chemotherapy-sensitive disease that has failed prior therapy
Ineligible for an autologous stem cell transplant
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, or follicular lymphoma that has progressed after ≥ 2 prior therapies
Lymphoplasmacytic lymphoma, mantle cell lymphoma, or prolymphocytic leukemia
Chemotherapy-sensitive disease that was previously treated with initial therapy
Mycosis fungoides and Sezary syndrome
Bone marrow failure syndromes, except for Fanconi anemia
Myeloproliferative syndromes NOTE: *Patients for whom adequate marrow/biopsy specimens can not be obtained to determine remission status by morphologic assessment must have fulfilled criteria of remission (< 5% blasts by flow cytometry and recovery of peripheral blood counts with no circulating blasts)
Ineligible for autologous stem cell transplant due to any of the following:
No evidence of progressive disease by imaging modalities or biopsy (persistent PET scan activity allowed provided there are no CT scan changes indicating progression)
Acute leukemia that is refractory, persistent, or relapsed (defined as > 5% blasts in normocellular bone marrow) allowed provided patient was rendered aplastic either by induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy
Patients with stable disease are eligible provided the largest residual nodal mass is approximately < 5 cm (largest residual mass must represent a 50% reduction and be approximately < 7.5 cm for patients who have responded to prior therapy)
No active CNS malignancy
Umbilical cord blood (UCB) donor available
UCB graft matched at 4/6 HLA-A, -B, and -DRB1 antigens with the recipient
If 2 UCB units are required to reach the target cell dose, each unit must be a 3/6 HLA-A, -B, and -DRB1 antigen match to each other, as well as a 4/6 antigen match to the recipient
No 5-6/6 HLA-A, -B, and -DRB1 matched sibling donor available
PATIENT CHARACTERISTICS:
Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100%
Creatinine ≤ 2.0 mg/dL (adults) OR creatinine clearance > 40 mL/min (pediatrics)
Not pregnant or nursing
Negative pregnancy test
LVEF ≥ 35%
DLCO > 30% predicted
No requirement for O_2
No decompensated congestive heart failure
No uncontrolled arrhythmia
None of the following liver diseases or conditions:
Recent mold infection (e.g., Aspergillus) allowed provided patient received ≥ 30 days of appropriate treatment AND infection is controlled and cleared by Infectious Disease
No evidence of HIV infection or known HIV-positive serology
No uncontrolled viral or bacterial infection
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Colleen Delaney, MD, MSC | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cyclophosphamide/Fludarabine/TBI | Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
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Not provided
Not provided
Not provided
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| cyclophosphamide |
| Drug |
50 mg/Kg Day -6 |
|
| cyclosporine | Drug | Patients will receive cyclosporine A (CSA) therapy beginning on Day -3 maintaining a trough level between 250 and 500 ng/mL. For adults the initial dose will be 2.5 mg/kg IV over 1 hour every 12 hours. For children < 40 kg the initial dose will be 2.5 mg/kg IV over 1 hour every 8 hours. |
|
| fludarabine phosphate | Drug | 40mg/m2 Days -6 to -2 |
|
| mycophenolate mofetil | Drug | 1 gram every 8 hours for patients who are ≥ 40 kg. Pediatric patients (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours. Stop MMF at Day +30 or 7 days after engraftment, whichever day is later, if no acute GVHD. |
|
| umbilical cord blood transplantation | Procedure | Single or double unit umbilical cord blood transplant |
|
| total body irradiation | Radiation | 200 cGy Day -1 |
|
| 6 months post transplant |
| Chimerism | Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant. | 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant |
| Incidence of Neutrophil Engraftment at Day 42 | Number of participants with neutrophil engraftment at day 42 | Day 42 post transplant |
| Incidence of Platelet Engraftment at 6 Months | Number of participants with platelet engraftment at 6 months | 6 months post transplant |
| Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100 | Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death) | Day 100 post transplant |
| Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100 | Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death) | Day 100 post transplant |
| Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year | Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year. Clinical Limited cGVHD
| 1 year post transplant |
| Incidence of Clinically Significant Infections at 6 Months | Number of participants with clinically significant infections at 6 months | 6 months post transplant |
| Incidence of Clinically Significant Infections at 1 Year | Number of participants with clinically significant infections at 1 year | 1 year post transplant |
| Incidence of Clinically Significant Infections at 2 Years | Number of participants with clinically significant infections at 2 years | 2 years post transplant |
| Probability of Progression-free Survival at 1 Year | Kaplan-Meier estimate of the probability of progression-free survival at 1 year | 1 year post transplant |
| Probability of Progression-free Survival at 2 Years | Kaplan-Meier estimate of the probability of progression-free survival at 2 years | 2 years post transplant |
| Incidence of Relapse at 1 Year | Number of participants with relapse at 1 year. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. | 1 year post transplant |
| Incidence of Relapse at 2 Years | Number of participants with relapse at 2 years. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. | 2 years post transplant |
| FG001 | Cyclophosphamide/Fludarabine/TBI/ATG | Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cyclophosphamide/Fludarabine/TBI | Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR patients with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil |
| BG001 | Cyclophosphamide/Fludarabine/TBI/ATG | Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months, and who should receive ATG as part of their conditioning regimen.
Immune suppression begin Day -3: cyclosporine and mycophenolate mofetil |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Disease Diagnosis | Count of Participants | Participants |
|
| 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 | Probability of Survival at 1 Year | Kaplan-Meier estimate of the probability of survival at 1 year | Posted | Number | 95% Confidence Interval | survival probability | 1 year post transplant |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Probability of Survival at 2 Years | Kaplan-Meier estimate of the probability of survival at 2 years | Posted | Number | 95% Confidence Interval | survival probability | 2 years post transplant |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of Non-relapse Mortality at 6 Months | Number of Participants with Non-relapse Mortality at 6 Months | Posted | Count of Participants | Participants | 6 months post transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Chimerism | Count of participants who experienced dominance of one cord blood unit (defined by >or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant. | Posted | Count of Participants | Participants | 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant |
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence of Neutrophil Engraftment at Day 42 | Number of participants with neutrophil engraftment at day 42 | Posted | Count of Participants | Participants | Day 42 post transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Platelet Engraftment at 6 Months | Number of participants with platelet engraftment at 6 months | Posted | Count of Participants | Participants | 6 months post transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) at Day 100 | Number of participants with Grade II-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death) | Posted | Count of Participants | Participants | Day 100 post transplant |
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) at Day 100 | Number of participants with Grade III-IV acute graft-versus-host-disease (GVHD) at day 100. Acute GVHD Staging and Grading: Overall grade 1: stage 1-2 skin, no liver or gut Overall grade 2: stage 3 skin or stage 1 liver or stage 1 gut Overall grade 3: stage 4 skin or stage 2-4 liver or stage 2-4 gut (without GVHD as a major contributing cause of death) Overall grade 4: stage 4 skin or stage 2-4 liver or stage 2-3 gut (with GVHD as a major contributing cause of death) | Posted | Count of Participants | Participants | Day 100 post transplant |
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence of Chronic Graft-versus-host-disease (GVHD) at 1 Year | Number of participants with chronic graft-versus-host-disease (GVHD) at 1 year. Clinical Limited cGVHD
| Posted | Count of Participants | Participants | 1 year post transplant |
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence of Clinically Significant Infections at 6 Months | Number of participants with clinically significant infections at 6 months | Posted | Count of Participants | Participants | 6 months post transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Clinically Significant Infections at 1 Year | Number of participants with clinically significant infections at 1 year | Posted | Count of Participants | Participants | 1 year post transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Incidence of Clinically Significant Infections at 2 Years | Number of participants with clinically significant infections at 2 years | Posted | Count of Participants | Participants | 2 years post transplant |
|
| |||||||||||||||||||||||||||||||
| Secondary | Probability of Progression-free Survival at 1 Year | Kaplan-Meier estimate of the probability of progression-free survival at 1 year | Posted | Number | 95% Confidence Interval | progression free survival probability | 1 year post transplant |
|
| ||||||||||||||||||||||||||||||
| Secondary | Probability of Progression-free Survival at 2 Years | Kaplan-Meier estimate of the probability of progression-free survival at 2 years | Posted | Number | 95% Confidence Interval | progression free survival probability | 2 years post transplant |
|
| ||||||||||||||||||||||||||||||
| Secondary | Incidence of Relapse at 1 Year | Number of participants with relapse at 1 year. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. | Posted | Count of Participants | Participants | 1 year post transplant |
| ||||||||||||||||||||||||||||||||
| Secondary | Incidence of Relapse at 2 Years | Number of participants with relapse at 2 years. Patients with leukemia and lymphoma involving the BM and multiple myeloma will have this done by BM biopsy and additional special studies such as cytogenetics or flow cytometry as appropriate. Patients with lymphoma and myeloma will have radiology studies such as plain X-rays or CT scans and/or other studies such as blood tumor markers to document presence or absence of disease as clinically indicated. | Posted | Count of Participants | Participants | 2 years post transplant |
|
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cyclophosphamide/Fludarabine/TBI | Subjects with hematological malignancies with prior autologous transplant, >2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil | 3 | 4 | 2 | 4 | ||
| EG001 | Cyclophosphamide/Fludarabine/TBI/ATG | Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil | 8 | 9 | 3 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Investigations |
| |||
| Relapse of underlying disease | Blood and lymphatic system disorders |
| |||
| Congestive heart failure | Cardiac disorders |
| |||
| MSOF leading to death | General disorders |
| |||
| Fever of unknown etiology | General disorders |
| |||
| Allergic reaction | Immune system disorders |
| |||
| Myopathy | Musculoskeletal and connective tissue disorders |
| |||
| Creatinine Phosphokinase | Metabolism and nutrition disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Infection with grade 3 ANC - blood | Infections and infestations |
| |||
| Infection with grade 3 ANC - lungs | Infections and infestations |
| |||
| ARDS | Respiratory, thoracic and mediastinal disorders |
| |||
| Infection with normal ANC - blood | Infections and infestations |
| |||
| Opportunistic infection associated with lymphopenia | Infections and infestations |
| |||
| Obstruction, GI - biliary tree | Gastrointestinal disorders |
| |||
| Hypoxia | Respiratory, thoracic and mediastinal disorders |
| |||
| Pneumonia | Infections and infestations |
| |||
| Hypertension | Cardiac disorders |
| |||
| Failure to engraft by day 42 | Blood and lymphatic system disorders |
| |||
| Encephalitis HHV6 | Infections and infestations |
| |||
| Supraventricular tachycardia | Cardiac disorders |
| |||
| Secondary graft failure | Blood and lymphatic system disorders |
| |||
| Acute renal failure | Renal and urinary disorders |
| |||
| Pulmonary VOD | Respiratory, thoracic and mediastinal disorders |
| |||
| Shortness of breath | Respiratory, thoracic and mediastinal disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acidosis | Metabolism and nutrition disorders |
| |||
| Glucose, serum-high | Metabolism and nutrition disorders |
| |||
| Potassium, serum-high | Metabolism and nutrition disorders |
| |||
| Potassium, serum-low | Metabolism and nutrition disorders |
| |||
| Sodium, serum-low | Metabolism and nutrition disorders |
| |||
| Lymphopenia | Blood and lymphatic system disorders |
| |||
| Platelets | Blood and lymphatic system disorders |
| |||
| Thrombus | Vascular disorders |
| |||
| Phosphate, serum-low | Metabolism and nutrition disorders |
| |||
| Magnesium, serum-high | Metabolism and nutrition disorders |
| |||
| Hemoglobin | Blood and lymphatic system disorders |
| |||
| Neutrophils | Blood and lymphatic system disorders |
| |||
| Leukocytes | Blood and lymphatic system disorders |
| |||
| Infection with grade 2 ANC - skin | Infections and infestations |
| |||
| Infection with normal ANC - blood | Infections and infestations |
| |||
| Infection with grade 4 ANC - blood | Infections and infestations |
| |||
| Infection with grade 4 ANC - oral | Infections and infestations |
| |||
| AST | Metabolism and nutrition disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Colleen Delaney | Fred Hutchinson Cancer Research Center | 2066671385 | cdelaney@fredhutch.org |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| D009190 | Myelodysplastic Syndromes |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| D054438 | Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D006689 | Hodgkin Disease |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054739 | Dendritic Cell Sarcoma, Interdigitating |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D012008 | Recurrence |
| D000753 | Anemia, Refractory |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D008258 | Waldenstrom Macroglobulinemia |
| D054429 | Leukemia, Myelomonocytic, Juvenile |
| C580364 | Pdgfra-Associated Chronic Eosinophilic Leukemia |
| D055728 | Primary Myelofibrosis |
| D015467 | Leukemia, Neutrophilic, Chronic |
| D013920 | Thrombocythemia, Essential |
| D011087 | Polycythemia Vera |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D001855 | Bone Marrow Diseases |
| D007951 | Leukemia, Myeloid |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| D015620 | Histiocytic Disorders, Malignant |
| D015614 | Histiocytosis |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D015448 | Leukemia, B-Cell |
| D000740 | Anemia |
| D001778 | Blood Coagulation Disorders |
| D013922 | Thrombocytosis |
| D001791 | Blood Platelet Disorders |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D036101 | Cord Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D007106 | Immune Sera |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| CML (Chronic Myeloid Leukemia) |
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| NHL (Non-Hodgkin's Lymphoma) |
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| MDS (Myelodysplastic Syndromes) |
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Subjects with hematological malignancies with prior autologous transplant >12 mos or <1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Participants |
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