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

Phase 3

Completed

• Conditions: Graft Versus Host Disease; Lymphoma; Myelodysplastic Syndromes; Secondary Myelofibrosis; Chronic Myeloproliferative Disorders; Leukemia

• Registration Number: NCT00438958
• Lead Sponsor: The Canadian Blood and Marrow Transplant Group

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.

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

* 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.

Study Timeline

• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-22
• Study Start: 2007-03
• Status Verified: 2009-07
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death)

Secondary Outcome Measures

Name	Time	Method
Quality of life
Chronic GVHD details
Cost
Time to neutrophil recovery
Overall survival
Time to chronic GVHD
Primary graft failure
Time to acute GVHD
Detailed donor and patient self-reported outcomes

Trial Locations

Locations (16)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

Institute of Medical and Veterinary Science; 🇦🇺 Adelaide, South Australia, Australia

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

Vancouver Hospital and Health Science Center; 🇨🇦 Vancouver, British Columbia, Canada

CancerCare Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada

Cancer Care Nova Scotia; 🇨🇦 Halifax, Nova Scotia, Canada

McMaster Children's Hospital at Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

London Regional Cancer Program at London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Ottawa Hospital Regional Cancer Centre - General Campus; 🇨🇦 Ottawa, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

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