Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer, Lymphoma, Orthopedic, Hematology, Leukemia |
| Therapuetic Areas: | Hematology, Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 16 - 65 |
| Updated: | 3/1/2014 |
| Start Date: | March 2007 |
A Randomized Multicentre Study Comparing G-CSF Mobilized Peripheral Blood and G-CSF Stimulated Bone Marrow in Patients Undergoing Matched Sibling Transplantation for Hematologic Malignancies
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.
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.
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
- Compare the hematological recovery and overall survival of patients treated with these
regimens.
- Compare the quality of life, in terms of extensive graft-versus-host disease (GVHD), in
patients treated with these regimens.
- Compare the economic impact associated with these treatment regimens.
Tertiary
- Compare the incidence and severity of acute GVHD in patients treated with these
regimens.
- Compare organ involvement, symptomatology, and functional impact of chronic GVHD in
patients treated with these regimens.
- Compare disease-free survival of patients treated with these regimens.
- Compare donor quality of life.
- 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).
- Myeloablative conditioning regimen: Patients receive a myeloablative conditioning
regimen that has been approved by the clinical chair.
- Stem cell transplantation (SCT): Patients are randomized to 1 of 2 SCT arms.
- Arm I: Patients undergo sibling donor filgrastim (G-CSF)-mobilized peripheral
blood SCT on day 0.
- Arm II: Patients undergo sibling donor G-CSF- mobilized bone marrow
transplantation on day 0.
- 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.
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
- Compare the hematological recovery and overall survival of patients treated with these
regimens.
- Compare the quality of life, in terms of extensive graft-versus-host disease (GVHD), in
patients treated with these regimens.
- Compare the economic impact associated with these treatment regimens.
Tertiary
- Compare the incidence and severity of acute GVHD in patients treated with these
regimens.
- Compare organ involvement, symptomatology, and functional impact of chronic GVHD in
patients treated with these regimens.
- Compare disease-free survival of patients treated with these regimens.
- Compare donor quality of life.
- 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).
- Myeloablative conditioning regimen: Patients receive a myeloablative conditioning
regimen that has been approved by the clinical chair.
- Stem cell transplantation (SCT): Patients are randomized to 1 of 2 SCT arms.
- Arm I: Patients undergo sibling donor filgrastim (G-CSF)-mobilized peripheral
blood SCT on day 0.
- Arm II: Patients undergo sibling donor G-CSF- mobilized bone marrow
transplantation on day 0.
- 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.
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
We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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