Phase 2
N=142
Combination Chemotherapy, Bone Marrow Transplant, and Post Transplant Cyclophosphamide for Hematologic Cancer
Chronic Myeloproliferative Disorders · Leukemia · Lymphoma · Multiple Myeloma and Plasma Cell Neoplasm · Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00134017 ↗Enrolled (actual)
142
Serious AEs
14.1%
Results posted
Aug 2018
Primary outcome: Primary: Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD) — 49; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Busulfan (Drug); Cyclophosphamide (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Develop Acute Graft-versus-host Disease (GVHD) |
49; 10 | — |
| SECONDARY Days to Engraftment |
23; 25; 31; 35 | — |
| SECONDARY Chimerism |
99; 101 | — |
| SECONDARY Non-relapse Mortality |
6; 15 | — |
| SECONDARY Relapse |
44 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00134017). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.