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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02055 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2012-0506 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase I/II trial studies the side effects and best dose of gemcitabine hydrochloride, clofarabine, and busulfan before donor stem cell transplant and to see how well it works in treating patients with B-cell or T-cell non-Hodgkin lymphoma or Hodgkin lymphoma that does not respond to treatment. Giving chemotherapy before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
PRIMARY OBJECTIVES:
I. To define the maximum tolerated dose (MTD) of infusional gemcitabine (gemcitabine hydrochloride) combined with fixed doses of clofarabine and busulfan in patients with lymphoma receiving an allogeneic stem-cell transplant (alloSCT).
II. To estimate the day +100 success rate, defined as percentage of patients who are alive, engrafted and without grade 3-4 graft-versus (vs.)-host-disease (GVHD).
SECONDARY OBJECTIVES:
I. To estimate the day +100 success rate (defined as percentage of patients who are alive, engrafted and without grade 3-4 graft-vs.-host-disease [GVHD]).
II. To estimate the rate of event-free (EFS). III. To estimate the rate of overall survival (OS). IV. To estimate the response rate (RR) (defined as # of responses / # of patients with measurable tumors).
V. To estimate the complete response (CR) rate (defined as # of complete responses / # of patients with measurable tumors).
VI. To estimate the incidence of grade 2-4 and grade 3-4 acute GVHD. VII. To estimate the incidence of limited and extensive chronic GVHD.
OUTLINE: This is a phase I, dose-escalation study of gemcitabine hydrochloride followed by a phase II study.
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride intravenously (IV) over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with cluster of differentiation (CD)20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic bone marrow (BMT) or peripheral blood stem cell transplant (PBSCT) on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or orally (PO). Beginning on day 0, patients receive mycophenolate mofetil IV over 2 hours or PO thrice daily (TID).
After completion of study treatment, patients are followed up at 3, 6, and 12 months, and then every 6 months for 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (gemcitabine, clofarabine, busulfan, BMT or PBSCT) | Experimental | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Bone Marrow Transplantation | Procedure | Undergo allogeneic BMT |
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| Measure | Description | Time Frame |
|---|---|---|
| Optimal Dose of Gemcitabine Hydrochloride Determined by Dose Limiting Toxicity | Dose limiting toxicity is defined as number of participants experienced grade 3-4 mucositis lasting for more than 3 days at peak severity, grade 3-4 skin toxicity lasting for more than 3 days at peak severity, occurring within 30 days from transplant, or grade 4 nonhematological/noninfectious toxicity. | Within 30 days of transplant |
| Number of Participants That Had 100 Day Success Rate Post Transplant | Number of participants that are alive, engrafted, without grade 3-4 GVHD within 100 days post transplant. | 100 days post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Number of participants that are still alive 5 years post transplant. | Up to 5 years |
| Treatment Related Mortality | Number of participants that expired from transplant other than disease relapse within the first 100 days post transplant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yago L Nieto, MD,PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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All participants were registered in MD Anderson Cancer Center
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1_475mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
| 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 | Apr 9, 2021 |
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| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Undergo allogeneic BMT or PBSCT |
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| Anti-Thymocyte Globulin | Biological | Given IV |
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| Busulfan | Drug | Given IV |
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| Clofarabine | Drug | Given IV |
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| Gemcitabine Hydrochloride | Drug | Given IV |
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| Mycophenolate Mofetil | Drug | Given IV then PO |
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| Peripheral Blood Stem Cell Transplantation | Procedure | Undergo allogeneic PBSCT |
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| Pharmacological Study | Other | Correlative studies |
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| Rituximab | Biological | Given IV |
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| Tacrolimus | Drug | Given IV then PO |
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| Up to 100 days post-transplant |
| FG001 | Cohort 2_675mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
| FG002 | Cohort 3_975mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1_475mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
| BG001 | Cohort 2_675mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
| BG002 | Cohort 3_975mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
| BG003 | 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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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | |||||||||||||||||||||||||||||
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| Primary | Optimal Dose of Gemcitabine Hydrochloride Determined by Dose Limiting Toxicity | Dose limiting toxicity is defined as number of participants experienced grade 3-4 mucositis lasting for more than 3 days at peak severity, grade 3-4 skin toxicity lasting for more than 3 days at peak severity, occurring within 30 days from transplant, or grade 4 nonhematological/noninfectious toxicity. | Posted | Count of Participants | Participants | Within 30 days of transplant |
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| Primary | Number of Participants That Had 100 Day Success Rate Post Transplant | Number of participants that are alive, engrafted, without grade 3-4 GVHD within 100 days post transplant. | Posted | Count of Participants | Participants | 100 days post transplant |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Number of participants that are still alive 5 years post transplant. | Posted | Count of Participants | Participants | Up to 5 years |
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| Secondary | Treatment Related Mortality | Number of participants that expired from transplant other than disease relapse within the first 100 days post transplant. | Posted | Count of Participants | Participants | Up to 100 days post-transplant |
|
5 years
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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 | Cohort 1_475mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO | 6 | 8 | 2 | 8 | 8 | 8 |
| EG001 | Cohort 2_675mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO | 16 | 24 | 2 | 24 | 24 | 24 |
| EG002 | Cohort 3_975mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO | 18 | 32 | 9 | 32 | 32 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bacterial | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| BL OTH | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bleeding (no GI no PUL) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Broncholitis obliterans | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fungal | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| GI OTH | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhagic Cystitis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Low granulocyte | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Low platelet | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Other | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Primary graft failure | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Secondary graft failure | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Sepsis like syndrome | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Viral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| ALK increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| ALT increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anemia | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Ascitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| AST increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Bacterial | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Bleeding (no GI no PUL) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Broncholitis obliterans | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Chest pain | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Chronic GVHD | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Confusion | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Cystitis noninfective | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Dysrhythmia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Ejection fraction decreased | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Flu like syndrome | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fluid overload | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Fungal | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| Gastrointestinal bleeding | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| GI OTH | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| GI ULC | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Haptoglobin | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hemorrhagic Cystitis | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
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| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| HP OTH | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
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| HSCT related microangiopathy (TA-TMA) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
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| LDH increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Low granulocyte | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Low platelet | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Lower Gl track obstruction | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Ocular GvHD | Eye disorders | CTCAE (4.0) | Systematic Assessment |
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| Oral GvHD | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Oral mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Other | General disorders | CTCAE (4.0) | Systematic Assessment |
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| Palmar-plantar erythrodysesthesia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Parasite | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PRES | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| PU OTH | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Schistocytes | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| T bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Thromboembolic event | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Viral | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| VOD | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wbc decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yago Nieto, MD, PhD/ Stem Cell Transplantation Department | University of Texas MD Anderson Cancer Center | 713-792-8750 | ynieto@mdanderson.org |
| Oct 16, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D006689 | Hodgkin Disease |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000961 | Antilymphocyte Serum |
| C512542 | thymoglobulin |
| D002066 | Busulfan |
| D000077866 | Clofarabine |
| D000093542 | Gemcitabine |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D000069283 | Rituximab |
| C000626854 | CT-P10 |
| D016559 | Tacrolimus |
| 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 |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D018942 | Macrolides |
| D007783 | Lactones |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Nonhematological/noninfectious toxicity |
|
| OG002 | Cohort 3_975mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
|
|
| OG002 | Cohort 3_975mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
|
|
| OG002 | Cohort 3_975mgm2 | PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8. TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0. Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Gemcitabine Hydrochloride: Given IV Mycophenolate Mofetil: Given IV then PO Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Pharmacological Study: Correlative studies Rituximab: Given IV Tacrolimus: Given IV then PO |
|
|