Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hemato… (NCT00134017) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer
United States142 participantsStarted 2004-06
Plain-language 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. 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. Giving cyclophosphamide, mycophenolate mofetil, or tacrolimus after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with tacrolimus and mycophenolate mofetil works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
Who can participate
Age range6 Months – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
* Genotypica…
What they're measuring
1
Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD)
Timeframe: Day 100
Trial details
NCT IDNCT00134017
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins