Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases
Study Details
Study Description
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 stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving colony-stimulating factors, such as G-CSF, to the donor helps the stem cells move from the bone marrow to the blood so they can be collected and stored. Giving methotrexate and cyclosporine before and after transplant may stop this from happening. It is not yet known whether a donor peripheral stem cell transplant is more effective than a donor bone marrow transplant in treating hematologic cancers or other diseases.
PURPOSE: This randomized phase III trial is studying filgrastim-mobilized sibling donor peripheral stem cell transplant to see how well it works compared with sibling donor bone marrow transplant in treating patients with hematologic cancers or other diseases.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 blood stem cell transplantation vs G-CSF-stimulated matched-sibling donor bone marrow transplantation.
Secondary
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Compare the hematological recovery and overall survival of patients treated with these regimens.
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Compare the quality of life, in terms of extensive graft-versus-host disease (GVHD), in patients treated with these regimens.
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Compare the economic impact associated with these treatment regimens.
Tertiary
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Compare the incidence and severity of acute GVHD in patients treated with these regimens.
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Compare organ involvement, symptomatology, and functional impact of chronic GVHD in patients treated with these regimens.
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Compare disease-free survival of patients treated with these regimens.
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Compare donor quality of life.
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Compare cost analysis, from a societal perspective, of these treatment regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center, disease (chronic myelogenous leukemia vs acute myeloid leukemia vs myelodysplastic syndromes vs other hematologic malignancy), disease stage (early disease vs late disease), and conditioning regimen (busulfan and cyclophosphamide vs cyclophosphamide and total body irradiation vs other).
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Myeloablative conditioning regimen: Patients receive a myeloablative conditioning regimen that has been approved by the clinical chair.
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Stem cell transplantation (SCT): Patients are randomized to 1 of 2 SCT arms.
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Arm I: Patients undergo sibling donor filgrastim (G-CSF)-mobilized peripheral blood SCT on day 0.
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Arm II: Patients undergo sibling donor G-CSF- mobilized bone marrow transplantation on day 0.
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Graft-verus-host disease (GVHD) treatment: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV (or orally) every 12 hours beginning on day -2 and continuing until day 100.
Quality of life is assessed at baseline and at 1 and 3 years post-transplantation.
After completion of study therapy, patients are followed periodically for at least 4 years.
PROJECTED ACCRUAL: A total of 230 patients will be accrued for this study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Arm I Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0. |
Biological: filgrastim
Given on day 0.
Procedure: peripheral blood stem cell transplantation
Given on day 0
|
| Experimental: Arm II Patients undergo G-CSF-mobilized sibling donor bone marrow transplantation on day 0. |
Biological: filgrastim
Given on day 0.
Procedure: allogeneic bone marrow transplantation
Given on day 0
|
Outcome Measures
Primary Outcome Measures
- Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death) []
Secondary Outcome Measures
- Time to neutrophil recovery []
- Primary graft failure []
- Overall survival []
- Quality of life []
- Time to acute GVHD []
- Time to chronic GVHD []
- Chronic GVHD details []
- Cost []
- Detailed donor and patient self-reported outcomes []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Diagnosis of one of the following hematologic malignancies:
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Acute myeloid leukemia in first complete remission or second complete remission
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Chronic myeloid leukemia in chronic or accelerated phase
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Myelodysplasia, including any of the following:
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Refractory anemia (RA)
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RA with ringed sideroblasts
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RA with excess blasts (RAEB) I
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RAEB in transformation
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Chronic myelomonocytic leukemia
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Other hematologic malignancy for which sibling donor stem cell transplantation with a myeloablative conditioning regimen is appropriate, including any of the following:
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Indolent non-Hodgkin's lymphoma (NHL)
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Aggressive NHL
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Chronic lymphocytic leukemia
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Hodgkin's lymphoma
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Myelofibrosis
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Hematologic malignancy not otherwise specified
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HLA-matched sibling donor available meeting all of the following criteria:
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6/6 HLA match
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HLA typing performed by serologic or DNA methodology for A and B and by DNA methodology for DRB1 (intermediate resolution)
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Not identical twin with patient
PATIENT CHARACTERISTICS:
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ECOG performance status 0-2
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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No cognitive, linguistic, or emotional difficulty that would preclude participation in the quality-of-life component of the study
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Able to communicate in English or French
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No HIV antibody positivity
PRIOR CONCURRENT THERAPY:
- Not specified
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | CancerCare Manitoba | Winnipeg | Manitoba | Canada | R3E 0V9 |
| 6 | Cancer Care Nova Scotia | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 7 | McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | Canada | L8N 3Z5 |
| 8 | London Regional Cancer Program at London Health Sciences Centre | London | Ontario | Canada | N6A 465 |
| 9 | Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | Canada | K1H 8L6 |
| 10 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 11 | Maisonneuve-Rosemont Hospital | Montreal | Quebec | Canada | H1T 2M4 |
| 12 | Royal Victoria Hospital - Montreal | Montreal | Quebec | Canada | H3A 1A1 |
| 13 | Hopital de L'Enfant Jesus | Quebec City | Quebec | Canada | G1J 1Z4 |
| 14 | Centre Hospitalier Universitaire de Quebec | Quebec City | Quebec | Canada | G1R 2J6 |
| 15 | Auckland City Hospital | Auckland | New Zealand | 1 | |
| 16 | King Faisal Specialist Hospital and Research Center | Riyadh | Saudi Arabia | 11211 |
Sponsors and Collaborators
- The Canadian Blood and Marrow Transplant Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Stephen Couban, MD, Cancer Care Nova Scotia
- : Jeffrey H. Lipton, MD, PhD, Princess Margaret Hospital, Canada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000528289
- CBMTG-0601