Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases

The Canadian Blood and Marrow Transplant Group

Status and phase

Completed

Phase 3

Conditions

Graft Versus Host Disease

Secondary Myelofibrosis

Chronic Myeloproliferative Disorders

Lymphoma

Leukemia

Myelodysplastic Syndromes

Treatments

Biological: filgrastim

Procedure: allogeneic bone marrow transplantation

Procedure: peripheral blood stem cell transplantation

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00438958

CDR0000528289

CBMTG-0601

Details and patient eligibility

About

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.

Full 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

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.

Enrollment

230 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: