Status:
COMPLETED
Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
6-65 years
Phase:
PHASE2
Brief Summary
RATIONALE: Giving chemotherapy before a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells...
Detailed Description
OBJECTIVES: Primary * Determine the optimal dose of post-transplant immunosuppression comprising high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil administered after myeloablative co...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following hematologic malignancies:
- Acute myeloid leukemia (AML), meeting 1 of the following criteria:
- AML beyond first complete remission (CR1)
- Refractory AML
- AML arising from myelodysplastic syndromes (MDS)
- Secondary AML
- MDS
- Refractory anemia with excess blasts with \> 10% blasts in bone marrow
- Acute lymphoblastic leukemia (ALL), meeting 1 of the following criteria:
- ALL in CR1 with 1 of the following high-risk features:
- Philadelphia chromosome (Ph)-positive disease
- Less than 1 year of age at diagnosis
- Cytogenetic abnormalities involving chromosome 11q23
- ALL beyond CR1
- Refractory ALL
- Chronic myeloid leukemia beyond first chronic phase
- Chronic myelomonocytic leukemia
- Chronic lymphocytic leukemia
- Stage III-IV disease
- Does not meet criteria for other bone marrow transplantation (BMT) studies
- Myeloproliferative disorders
- Ph-negative disease
- Hodgkin's or non-Hodgkin's lymphoma
- Chemotherapy-resistant disease
- Paroxysmal nocturnal hemoglobinuria with life-threatening thrombosis
- Multiple myeloma
- Stage II or III disease
- Very high-risk disease
- Having an unrelated donor is considered a high-risk condition
- Meets medical criteria for myeloablative BMT for the Sidney Kimmel Comprehensive Cancer Center
- Bone marrow donor available, meeting 1 of the following criteria:
- Genotypically HLA-identical sibling
- Phenotypically matched first-degree relative
- Unrelated donor molecularly matched at HLA-A, -B, -C, -DRB1, and -DQB1
- PATIENT CHARACTERISTICS:
- Age
- 6 months to 65 years
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- See Disease Characteristics
- Hepatic
- Not specified
- Renal
- Not specified
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- See Disease Characteristics
- Endocrine therapy
- No concurrent dexamethasone as an antiemetic during immunosuppression therapy
- Radiotherapy
- Not specified
- Surgery
- Not specified
- Other
- No concurrent immunosuppressants until ≥ 24 hours after the completion of cyclophosphamide (post-transplantation)
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00134017
Start Date
June 1 2004
End Date
February 1 2010
Last Update
August 31 2018
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410