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

March 4, 2014 updated by: The Canadian Blood and Marrow Transplant Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Institute of Medical and Veterinary Science
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E3
        • Vancouver Hospital and Health Science Center
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Cancer Care Nova Scotia
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
      • London, Ontario, Canada, N6A 465
        • London Regional Cancer Program at London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Regional Cancer Centre - General Campus
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital - Montreal
      • Quebec City, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
      • Quebec City, Quebec, Canada, G1J 1Z4
        • Hopital de L'enfant Jesus
  • New Zealand
      • Auckland, New Zealand, 1
        • Auckland City Hospital
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital and Research Center
  • United States
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I
Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0.
Procedure: peripheral blood stem cell transplantation
Given on day 0
Biological: filgrastim
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Canadian Blood and Marrow Transplant Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Stephen Couban, MD, Cancer Care Nova Scotia
  • Jeffrey H. Lipton, MD, PhD, Princess Margaret Hospital, Canada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 22, 2007

Study Record Updates

Last Update Posted (Estimate)

March 5, 2014

Last Update Submitted That Met QC Criteria

March 4, 2014

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000528289
  • CBMTG-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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