Status:
COMPLETED
Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases
Lead Sponsor:
The Canadian Blood and Marrow Transplant Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Eligibility:
All Genders
16-65 years
Phase:
PHASE3
Brief Summary
RATIONALE: Giving chemotherapy before a donor peripheral stem cell transplant or bone marrow transplant using stem cells from a brother or sister that closely match the patient's stem cells, helps sto...
Detailed Description
OBJECTIVES: Primary * Compare the time to treatment failure in patients with hematologic malignancies or other diseases treated with filgrastim (G-CSF)-mobilized matched-sibling donor peripheral blo...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of one of the following hematologic malignancies:
- Acute myeloid leukemia in first complete remission or second complete remission
- Chronic myeloid leukemia in chronic or accelerated phase
- Myelodysplasia, including any of the following:
- Refractory anemia (RA)
- RA with ringed sideroblasts
- RA with excess blasts (RAEB) I
- RAEB in transformation
- Chronic myelomonocytic leukemia
- Other hematologic malignancy for which sibling donor stem cell transplantation with a myeloablative conditioning regimen is appropriate, including any of the following:
- Indolent non-Hodgkin's lymphoma (NHL)
- Aggressive NHL
- Chronic lymphocytic leukemia
- Hodgkin's lymphoma
- Myelofibrosis
- Hematologic malignancy not otherwise specified
- HLA-matched sibling donor available meeting all of the following criteria:
- 6/6 HLA match
- HLA typing performed by serologic or DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution)
- Not identical twin with patient
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No cognitive, linguistic, or emotional difficulty that would preclude participation in the quality-of-life component of the study
- Able to communicate in English or French
- No HIV antibody positivity
- PRIOR CONCURRENT THERAPY:
- Not specified
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00438958
Start Date
March 1 2007
Last Update
March 5 2014
Active Locations (16)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
2
Institute of Medical and Veterinary Science
Adelaide, South Australia, Australia, 5000
3
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
4
Vancouver Hospital and Health Science Center
Vancouver, British Columbia, Canada, V5Z 4E3