Status:
COMPLETED
Cyclophosphamide and/or Mycophenolate Mofetil With or Without Tacrolimus in Treating Patients Who Are Undergoing a Donor Bone Marrow or Peripheral Stem Cell Transplant for Hematologic Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the growth of cancer cells. It also stops the pati...
Detailed Description
OBJECTIVES: * Determine a minimal (short-duration) post-transplant immunosuppression regimen comprising cyclophosphamide and/or mycophenolate mofetil with or without tacrolimus that results in ≤ 20% ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Stage II or III multiple myeloma
- Amyloidosis
- Myelofibrosis with ≥ 2 of the following high-risk features:
- Over 55 years of age
- Hemoglobin \< 10 g/dL
- WBC \< 3,000/mm\^3 OR \> 10,000/mm\^3
- Platelet count \< 100,000/mm\^3
- Cytogenetic abnormalities
- Mycosis fungoides, meeting 1 of the following criteria:
- Stage IIB or III disease with evidence of histologic conversion to an aggressive lymphoma
- Must demonstrate chemosensitivity
- Stage IV disease
- Paroxysmal nocturnal hemoglobinuria
- Not meeting criteria for other bone marrow transplantation (BMT) or treatment studies
- Diagnosis of 1 of the following hematologic malignancies, for which patient is not eligible for potentially curative allogeneic BMT due to end-organ dysfunction, age 65 to 75, or the amount of prior chemotherapy:
- Acute myeloid or acute lymphoblastic leukemia
- High-risk disease in first or second (or further) complete remission
- Relapsed aggressive non-Hodgkin's lymphoma
- Not eligible for autologous or standard allogeneic BMT
- Hodgkin's lymphoma in second or further complete or partial remission
- Not eligible for autologous or standard allogeneic BMT
- Myelodysplastic syndromes or myelodysplastic/myeloproliferative diseases
- Any of the following subtypes:
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Chronic myelomonocytic leukemia
- Any morphologic subtype with multiple chromosomal abnormalities
- Any subset with life-threatening cytopenias in all 3 cell lines, defined as platelet count ≤ 20,000/mm\^3, absolute neutrophil count ≤ 500/mm\^3, and reticulocyte count ≤ 50,000/mm\^3
- Meets both of the following criteria:
- Less than 20% blasts by bone marrow biopsy
- Not eligible for standard allogeneic BMT
- No refractory anemia with ringed sideroblasts
- No 5q syndrome
- Stage III or IV chronic lymphocytic leukemia
- Not meeting criteria for other BMT studies
- Chronic myelogenous leukemia in first or second chronic phase
- Not meeting criteria for other BMT studies or treatment
- Stage III or IV indolent small lymphocytic or follicular lymphoma
- Not eligible for autologous or standard allogeneic BMT or other active protocols at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Must have an HLA-identical related donor available
- PATIENT CHARACTERISTICS:
- Performance status
- ECOG 0-2
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Bilirubin ≤ 3.0 mg/dL
- AST ≤ 175 U/L
- ALT ≤ 200 U/L
- Renal
- Creatinine ≤ 3.0 mg/dL
- Cardiovascular
- LVEF ≥ 30%
- Pulmonary
- FEV\_1 ≥ 40% predicted
- Forced vital capacity ≥ 40% predicted
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- PRIOR CONCURRENT THERAPY:
- Chemotherapy
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00255710
Start Date
July 1 2002
Last Update
March 17 2010
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410