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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01069 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 44417 | Other Identifier | Roswell Park Cancer Institute |
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This phase Ib/2 trial studies how well chemotherapy, total body irradiation, and post-transplant cyclophosphamide work in reducing rates of graft versus host disease in patients with hematologic malignancies undergoing a donor stem cell transplant. Drugs used in the chemotherapy, such as fludarabine phosphate and melphalan hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). Giving cyclophosphamide after the transplant may stop this from happening.
PRIMARY OBJECTIVES:
I. To determine the cumulative incidence of extensive chronic graft versus host disease (GVHD) at 1 year after transplantation utilizing the novel conditioning/GVHD prophylactic regimen for patients undergoing allogeneic hematopoietic cell transplantation, in patients who do not progress before day 100.
SECONDARY OBJECTIVES:
I. To evaluate clinical response, engraftment rate, progression-free survival (PFS) at one year and, overall survival (OS).
II. To determine the cumulative incidence of relapse. III. To evaluate the day 100 transplant-related mortality rate. IV. To determine the cumulative incidence of grade III-IV acute GVHD.
OUTLINE: This is a dose-escalation study of melphalan hydrochloride.
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo total body irradiation (TBI) on day -1.
STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and tacrolimus IV and then orally (PO) once tolerated on days 5-180 with a taper beginning on day 100.
After completion of study treatment, patients are followed up for 12 months and then annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| <=50 years of age Cohort A | Experimental | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
|
| <=50 years of age Cohort B | Experimental | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
|
| >50 years of age Cohort A -25 mg/m2 Melphalan | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation | Procedure | Undergo allogeneic hematopoietic stem cell transplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extensive Chronic Graft Versus Host Disease (GVHD) | Percentage of chronic GVHD of response by human leukocyte antigen (HLA) matching by cohort | Up to 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Assessed as Per Bone Marrow Transplant (BMT) Standard of Care | Patients who achieved a clinical response will be summarized descriptively using frequency counts | Up to 4 years |
| Cumulative Incidence of Grade III-IV Acute Graft Versus Host Disease (GVHD) |
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Inclusion Criteria:
The patient must have a diagnosis of one of the following (one must be yes):
Histocompatible donor identified:
Patients with severe aplastic anemia do not have disease requirements; however, if the patient has a mismatched donor, the patient must have had prior therapy with ATG.
The following are eligible for study inclusion:
Patients with MDS/MPN only require <5% myeloblast on bone marrow evaluation.
Patients with AML, ALL or CLL may be in CRi, patients with MM may be in VGPR
Patients with NHL/HL must be in CR
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen Ross | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | <=50 Years of Age Cohort A | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| 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 | Jun 5, 2023 |
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Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100.
|
| >50 years of age Cohort B 50 mg/m2 Melphalan | Experimental | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
|
| >50 years of age Cohort C .75 mg/m2 Melphalan | Experimental | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
|
|
| Cyclophosphamide | Drug | Given IV |
|
|
| Fludarabine Phosphate | Drug | Given IV |
|
|
| Laboratory Biomarker Analysis | Other | Correlative studies |
|
| Melphalan Hydrochloride | Drug | Given IV |
|
|
| Mycophenolate Mofetil | Drug | Given IV |
|
|
| Sirolimus | Drug | Given IV and PO |
|
|
| Total-Body Irradiation | Radiation | Undergo TBI |
|
|
Will be analyzed in a descriptive fashion with means +/- standard deviations or frequency counts. Will examine in a post-hoc analysis potential chronic GVHD rates of response by human leukocyte antigen (HLA) matching status. |
| Up to 4 years |
| Cumulative Incidence of Relapse | Will be analyzed in a descriptive fashion with frequency counts. | Up to 4 years |
| Engraftment Rate Assessed as Per Bone Marrow Transplant (BMT) Standard of Care | Will be analyzed in a descriptive fashion with frequency counts. | Up to 4 years |
| Overall Survival Assessed as Per Bone Marrow Transplant (BMT) Standard of Care | Will utilize either straight Kaplan-Meier based estimators or extensions of nonparametric survival models to account for competing risks. | Up to 4 years |
| 1-Year Progression Free Survival (PFS) Rate Assessed as Per Bone Marrow Transplant (BMT) Standard of Care | Will utilize either straight Kaplan-Meier based estimators or extensions of nonparametric survival models to account for competing risks. | At 1 year |
| Treatment-related Mortality Rates | Count of participants that died by cohort. | All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months. |
| FG001 | <=50 Years of Age Cohort B | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| FG002 | >50 Years of Age Cohort A -25 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| FG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| FG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| COMPLETED |
|
| NOT COMPLETED |
|
All treated and evaluable patients
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| ID | Title | Description |
|---|---|---|
| BG000 | <=50 Years of Age Cohort A | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| BG001 | <=50 Years of Age Cohort B | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| BG002 | >50 Years of Age Cohort A -25 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| BG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| BG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| BG005 | 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 | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | 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 | Extensive Chronic Graft Versus Host Disease (GVHD) | Percentage of chronic GVHD of response by human leukocyte antigen (HLA) matching by cohort | All treated and evaluable patients | Posted | Number | percentage of participants | Up to 365 days |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response Assessed as Per Bone Marrow Transplant (BMT) Standard of Care | Patients who achieved a clinical response will be summarized descriptively using frequency counts | All treated and evaluable patients | Posted | Count of Participants | Participants | Up to 4 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Grade III-IV Acute Graft Versus Host Disease (GVHD) | Will be analyzed in a descriptive fashion with means +/- standard deviations or frequency counts. Will examine in a post-hoc analysis potential chronic GVHD rates of response by human leukocyte antigen (HLA) matching status. | All treated and eligible patients | Posted | Count of Participants | Participants | Up to 4 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Relapse | Will be analyzed in a descriptive fashion with frequency counts. | All treated and eligible patients | Posted | Count of Participants | Participants | Up to 4 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Engraftment Rate Assessed as Per Bone Marrow Transplant (BMT) Standard of Care | Will be analyzed in a descriptive fashion with frequency counts. | All treated and eligible patients | Posted | Count of Participants | Participants | Up to 4 years |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival Assessed as Per Bone Marrow Transplant (BMT) Standard of Care | Will utilize either straight Kaplan-Meier based estimators or extensions of nonparametric survival models to account for competing risks. | All treated and evaluable patients | Posted | Median | 95% Confidence Interval | months | Up to 4 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 1-Year Progression Free Survival (PFS) Rate Assessed as Per Bone Marrow Transplant (BMT) Standard of Care | Will utilize either straight Kaplan-Meier based estimators or extensions of nonparametric survival models to account for competing risks. | All treated and eligible patients | Posted | Number | 95% Confidence Interval | percentage of participants | At 1 year |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Treatment-related Mortality Rates | Count of participants that died by cohort. | All treated and evaluable patients | Posted | Count of Participants | Participants | All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months. |
|
All-Cause Mortality monitored/assessed up to 4 years. Adverse Events monitored/assessed from the start date of the conditioning regimen (Day -5) until 30 days after stem cell infusion will be reported, up to 12 months
The descriptions and grading scales found in the CTEP Version 4.0 of the NCI Common Terminology Criteria for Adverse Events (CTCAE) will be utilized for AE reporting. CTEP Version 4.0 of the CTCAE is identified and located at: http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm.
AEs not covered by specific terminology listed should be reported with common medical terminology, and documented according to the grading scales provided in the CTCAE Version 4.0.
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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 | <=50 Years of Age Cohort A | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and 50mg/m2 melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | <=50 Years of Age Cohort B | Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan hydrochloride IV over 30 minutes on day -2. Patients undergo TBI on day -1. Patients recieve 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | >50 Years of Age Cohort A -25 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. | 0 | 3 | 1 | 3 | 3 | 3 |
| EG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. | 5 | 6 | 4 | 6 | 4 | 6 |
| EG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. | 10 | 22 | 5 | 22 | 20 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Heart failure | Cardiac disorders | Systematic Assessment |
| ||
| Colonic fistula | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colonic obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fever | General disorders and administration site conditions | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Esophageal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders and administration site conditions | Systematic Assessment |
| ||
| Fatigue | General disorders and administration site conditions | Systematic Assessment |
| ||
| Fever | General disorders and administration site conditions | Systematic Assessment |
| ||
| General disorders and administration site conditions - Other, specify | General disorders and administration site conditions | Systematic Assessment |
| ||
| Localized edema | General disorders and administration site conditions | Systematic Assessment |
| ||
| Neck edema | General disorders and administration site conditions | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders and administration site conditions | Systematic Assessment |
| ||
| Pain | General disorders and administration site conditions | Systematic Assessment |
| ||
| Cytokine release syndrome | Immune system disorders | Systematic Assessment |
| ||
| Catheter related infection | Infections and infestations | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Ejection fraction decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Glucose intolerance | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Dysarthria | Nervous system disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Sinus pain | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Confusion | Psychiatric disorders | Systematic Assessment |
| ||
| Delirium | Psychiatric disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Cystitis noninfective | Renal and urinary disorders | Systematic Assessment |
| ||
| Genital edema | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Reproductive system and breast disorders - Other, specify | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Laryngeal mucositis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sore throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Periorbital edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Lymphedema | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maureen Ross | Roswell Park Cancer Institute | 7168451300 | Maureen.Ross@RoswellPark.org |
| Feb 12, 2026 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D006086 | Graft vs Host Disease |
| D006689 | Hodgkin Disease |
| D018365 | Neoplasm, Residual |
| D009190 | Myelodysplastic Syndromes |
| D009196 | Myeloproliferative Disorders |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| D000741 | Anemia, Aplastic |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D009385 | Neoplastic Processes |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D000740 | Anemia |
| D000080983 | Bone Marrow Failure Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C042382 | fludarabine phosphate |
| D008558 | Melphalan |
| D009173 | Mycophenolic Acid |
| D020123 | Sirolimus |
| 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 |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018942 | Macrolides |
| D007783 | Lactones |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | >50 Years of Age Cohort A -25 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
| OG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
| OG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
|
|
| OG002 | >50 Years of Age Cohort A -25 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| OG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| OG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
|
|
| >50 Years of Age Cohort A -25 mg/m2 Melphalan |
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| OG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| OG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
|
|
| OG002 |
| >50 Years of Age Cohort A -25 mg/m2 Melphalan |
Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| OG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| OG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
|
|
| OG002 | >50 Years of Age Cohort A -25 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
| OG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
| OG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
|
|
| OG002 | >50 Years of Age Cohort A -25 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| OG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
| OG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. |
|
|
| OG002 | >50 Years of Age Cohort A -25 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2.75 mg/m2 Patients receive 25 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
| OG003 | >50 Years of Age Cohort B 50 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, Patients receive 50 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
| OG004 | >50 Years of Age Cohort C .75 mg/m2 Melphalan | Following the administration of Fludarabine 40 mg/m2/day on Days -5 to -2, patients receive 75 mg/m2 Melphalan STEM CELL INFUSION: Patients undergo allogeneic hematopoietic stem cell transplant on day 0. GVHD PROPHYLAXIS REGIMEN: Patients receive cyclophosphamide IV over 2 hours on days 3-4, mycophenolate mofetil IV over 2 hours on days 5-35, and sirolimus IV and then PO once tolerated on days 5-180 with a taper beginning on day 100. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplant Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan Hydrochloride: Given IV Mycophenolate Mofetil: Given IV Sirolimus: Given IV and PO Total-Body Irradiation: Undergo TBI |
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