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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

Primary Purpose

Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
filgrastim
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
Sponsored by
The Canadian Blood and Marrow Transplant Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloproliferative Disorders focused on measuring 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, recurrent adult lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/Sezary syndrome, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV marginal zone lymphoma, stage IV small lymphocytic lymphoma, Waldenström macroglobulinemia, secondary acute myeloid leukemia, childhood myelodysplastic syndromes

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center
  • Institute of Medical and Veterinary Science
  • Royal Melbourne Hospital
  • Vancouver Hospital and Health Science Center
  • CancerCare Manitoba
  • Cancer Care Nova Scotia
  • McMaster Children's Hospital at Hamilton Health Sciences
  • London Regional Cancer Program at London Health Sciences Centre
  • Ottawa Hospital Regional Cancer Centre - General Campus
  • Princess Margaret Hospital
  • Maisonneuve-Rosemont Hospital
  • Royal Victoria Hospital - Montreal
  • Hopital de L'Enfant Jesus
  • Centre Hospitalier Universitaire de Quebec
  • Auckland City Hospital
  • King Faisal Specialist Hospital and Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0.

Patients undergo G-CSF-mobilized sibling donor bone marrow transplantation on day 0.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2007
Last Updated
March 4, 2014
Sponsor
The Canadian Blood and Marrow Transplant Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00438958
Brief Title
Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Canadian Blood and Marrow Transplant Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndromes, Secondary Myelofibrosis
Keywords
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, recurrent adult lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/Sezary syndrome, recurrent small lymphocytic lymphoma, splenic marginal zone lymphoma, stage III adult Burkitt lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III adult Hodgkin lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage III mantle cell lymphoma, stage III marginal zone lymphoma, stage III small lymphocytic lymphoma, stage IV adult Burkitt lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV mantle cell lymphoma, stage IV marginal zone lymphoma, stage IV small lymphocytic lymphoma, Waldenström macroglobulinemia, secondary acute myeloid leukemia, childhood myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Active Comparator
Arm Description
Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients undergo G-CSF-mobilized sibling donor bone marrow transplantation on day 0.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Description
Given on day 0.
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Description
Given on day 0
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Description
Given on day 0
Primary Outcome Measure Information:
Title
Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death)
Secondary Outcome Measure Information:
Title
Time to neutrophil recovery
Title
Primary graft failure
Title
Overall survival
Title
Quality of life
Title
Time to acute GVHD
Title
Time to chronic GVHD
Title
Chronic GVHD details
Title
Cost
Title
Detailed donor and patient self-reported outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Couban, MD
Organizational Affiliation
Cancer Care Nova Scotia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeffrey H. Lipton, MD, PhD
Organizational Affiliation
Princess Margaret Hospital, Canada
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Institute of Medical and Veterinary Science
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Vancouver Hospital and Health Science Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E3
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Cancer Care Nova Scotia
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
London Regional Cancer Program at London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 465
Country
Canada
Facility Name
Ottawa Hospital Regional Cancer Centre - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Maisonneuve-Rosemont Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Royal Victoria Hospital - Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Hopital de L'Enfant Jesus
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1
Country
New Zealand
Facility Name
King Faisal Specialist Hospital and Research Center
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
28935847
Citation
Kariminia A, Ivison S, Ng B, Rozmus J, Sung S, Varshney A, Aljurf M, Lachance S, Walker I, Toze C, Lipton J, Lee SJ, Szer J, Doocey R, Lewis I, Smith C, Chaudhri N, Levings MK, Broady R, Devins G, Szwajcer D, Foley R, Mostafavi S, Pavletic S, Wall DA, Couban S, Panzarella T, Schultz KR. CD56bright natural killer regulatory cells in filgrastim primed donor blood or marrow products regulate chronic graft-versus-host disease: the Canadian Blood and Marrow Transplant Group randomized 0601 study results. Haematologica. 2017 Nov;102(11):1936-1946. doi: 10.3324/haematol.2017.170928. Epub 2017 Sep 21.
Results Reference
derived

Learn more about this trial

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

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