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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00438958
First received: February 20, 2007
Last updated: March 4, 2014
Last verified: July 2009
  Purpose

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 Intervention Phase
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Secondary Myelofibrosis
Biological: filgrastim
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to neutrophil recovery [ Designated as safety issue: No ]
  • Primary graft failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
  • Time to acute GVHD [ Designated as safety issue: No ]
  • Time to chronic GVHD [ Designated as safety issue: No ]
  • Chronic GVHD details [ Designated as safety issue: No ]
  • Cost [ Designated as safety issue: No ]
  • Detailed donor and patient self-reported outcomes [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: March 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438958

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00438958     History of Changes
Other Study ID Numbers: CDR0000528289, CBMTG-0601
Study First Received: February 20, 2007
Last Updated: March 4, 2014
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
graft versus host disease
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
refractory anemia with excess blasts in transformation
refractory anemia with excess blasts
refractory anemia with ringed sideroblasts
refractory anemia
chronic myelomonocytic leukemia
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
refractory chronic lymphocytic leukemia
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
primary myelofibrosis
secondary myelofibrosis
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma

Additional relevant MeSH terms:
Graft vs Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasm Metastasis
Preleukemia
Primary Myelofibrosis
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on November 25, 2014