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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00238 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2064.00 | Other Identifier | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This phase II trial studies how well total-body irradiation (TBI) works when given together with fludarabine phosphate and cyclophosphamide followed by donor bone marrow transplant, mycophenolate mofetil, and cyclosporine in treating patients with Fanconi anemia (FA). Giving low doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and TBI before or after a donor bone marrow transplant helps stop the growth of 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 mycophenolate mofetil and cyclosporine after the transplant may stop this from happening.
PRIMARY OBJECTIVES:
I. Identify doses of total-body irradiation (TBI) that lead to sufficient probability of donor engraftment (> 5% donor cluster of differentiation [CD]3 chimerism) by day +200.
II. Evaluate the probability of severe acute graft-versus-host disease.
SECONDARY OBJECTIVES:
I. Evaluate the probabilities of overall survival, regimen-related toxicity (RRT), and recurrent hematopoietic malignancy in those patients with a prior underlying history of such.
II. Examine the degree to which mixed chimerism provides for amelioration of symptoms (i.e., infections due to neutropenia, hemorrhage due to thrombocytopenia) associated with bone marrow failure.
III. Determine if the FA complementation group and % initial mosaicism predict engraftment and RRT outcomes.
OUTLINE: Patients are assigned to 1 of 4 treatment arms.
NOTE: Patients no longer receive pre-transplant cyclophosphamide as of February 2009.
After completion of study treatment, patients are followed up at 6 months and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (2 vs 2.5 vs 3 Gy TBI dose-escalation) | Experimental | Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. |
|
| Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI de-escalation) | Experimental | Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. |
|
| Arm III (2 vs 2.5 vs 3 Gy TBI dose-escalation) | Experimental | Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Bone Marrow Transplantation | Procedure | Undergo allogeneic bone marrow transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Engraft at Each Dose of TBI Used | Number of subjects who engrafted. Engraftment defined as greater than 95% donor chimerism. | Up to Day 200 |
| Incidence of Grades III-IV Acute GVHD | Number of subjects who developed maximum grade acute graft-vs-host disease aGVHD Stages Skin:
Liver:
Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death | Up to Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Transplant-related Mortality | Number of subjects who expired due to transplant-related mortality | Up to Day 200 |
| Incidence of Adverse Events | Number of subjects who developed reportable AEs, assessed using adapted version of the Common Toxicity Criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans-Peter Kiem | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609-1809 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI de-escalation) | Experimental | Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. |
|
|
| Cyclophosphamide | Drug | Given IV |
|
|
| Cyclosporine | Drug | Given IV or PO |
|
|
| Fludarabine Phosphate | Drug | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Mycophenolate Mofetil | Drug | Given PO |
|
|
| Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Undergo allogeneic stem cell transplant |
|
|
| Total-Body Irradiation | Radiation | Undergo TBI |
|
|
| Up to Day 100 |
| Vanderbilt University/Ingram Cancer Center |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| Universidade Federal do Paraná | Curitiba | Paraná | 80060-000 | Brazil |
| FG001 | Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| FG002 | Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| FG003 | Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| COMPLETED |
|
| NOT COMPLETED |
|
No subjects meeting the criteria for Arms I or IV were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| BG001 | Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| BG002 | Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| BG003 | Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Patients Who Engraft at Each Dose of TBI Used | Number of subjects who engrafted. Engraftment defined as greater than 95% donor chimerism. | No subjects meeting the criteria for Arms I or IV were enrolled. | Posted | Count of Participants | Participants | Up to Day 200 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Incidence of Grades III-IV Acute GVHD | Number of subjects who developed maximum grade acute graft-vs-host disease aGVHD Stages Skin:
Liver:
Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death | No subjects meeting the criteria for Arms I or IV were enrolled. | Posted | Count of Participants | Participants | Up to Day 100 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Transplant-related Mortality | Number of subjects who expired due to transplant-related mortality | No subjects meeting the criteria for Arms I or IV were enrolled. | Posted | Count of Participants | Participants | Up to Day 200 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Adverse Events | Number of subjects who developed reportable AEs, assessed using adapted version of the Common Toxicity Criteria | No subjects meeting the criteria for Arms I or IV were enrolled. | Posted | Count of Participants | Participants | Up to Day 100 |
|
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
No subjects meeting the criteria for Arms I or IV were enrolled.
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 | Arm I (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with a history of hematologic malignancy and HLA-haploidentical donor receive fludarabine phosphate (FLU) intravenously (IV) over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF orally (PO) thrice daily (TID) on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI | 2 | 5 | 2 | 5 | 3 | 5 |
| EG002 | Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Infections and infestations | Systematic Assessment | Septic shock |
| |
| severe abdominal pain associated with GVHD | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mucositis | Gastrointestinal disorders | Systematic Assessment |
| ||
| elevated bilitrubin | Hepatobiliary disorders | Systematic Assessment |
| ||
| pulmonary hemorrage | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hans-Peter Kiem | Fred Hutchinson Cancer Research Center | 206-667-4425 | hkiem@fredhutch.org |
| ID | Term |
|---|---|
| D005199 | Fanconi Anemia |
| ID | Term |
|---|---|
| D029502 | Anemia, Hypoplastic, Congenital |
| D000741 | Anemia, Aplastic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000080984 | Congenital Bone Marrow Failure Syndromes |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D016572 | Cyclosporine |
| D003524 | Cyclosporins |
| C042382 | fludarabine phosphate |
| D009173 | Mycophenolic Acid |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Brazil |
|
| OG001 | Arm II (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-haploidentical donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| OG002 | Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| OG003 | Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
|
|
| OG002 | Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| OG003 | Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
|
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| OG002 | Arm III (2 vs 2.5 vs 3 Gy TBI Dose-escalation) | Patients with history of hematologic malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
| OG003 | Arm IV (2 vs 2.5 vs 3 vs 1 vs 0 Gy TBI De-escalation) | Patients with no history of hematological malignancy and HLA-matched unrelated donors receive FLU IV over 1 hour on days -6 to -2, and undergo TBI on day -1 and allogeneic bone marrow transplant on day 0. Patients then receive CY IV over 1 hour on days 3 and 4, MMF PO TID on days 5-35, and CSP IV or PO on days 5-84, with taper until day 180, in the absence of GVHD. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Cyclophosphamide: Given IV Cyclosporine: Given IV or PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant Total-Body Irradiation: Undergo TBI |
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