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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00438958
• Other study ID #: CDR0000528289
• Secondary ID: CBMTG-0601
• Status: Completed
• Phase: Phase 3
• First received: February 20, 2007
• Last updated: March 4, 2014
• Start date: March 2007

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Graft Versus Host Disease
• Graft vs Host Disease
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myeloproliferative Disorders
• Preleukemia
• Primary Myelofibrosis
• Secondary Myelofibrosis

Intervention

Biological:
• filgrastim
Given on day 0.

Procedure:
• allogeneic bone marrow transplantation
Given on day 0
• peripheral blood stem cell transplantation
Given on day 0

Locations

Country	Name	City	State
Australia	Institute of Medical and Veterinary Science	Adelaide	South Australia
Australia	Royal Melbourne Hospital	Parkville	Victoria
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	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Canada	Royal Victoria Hospital - Montreal	Montreal	Quebec
Canada	Ottawa Hospital Regional Cancer Centre - General Campus	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Hopital de L'Enfant Jesus	Quebec City	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Vancouver Hospital and Health Science Center	Vancouver	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba
New Zealand	Auckland City Hospital	Auckland
Saudi Arabia	King Faisal Specialist Hospital and Research Center	Riyadh
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
The Canadian Blood and Marrow Transplant Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death)			No
Secondary	Time to neutrophil recovery			No
Secondary	Primary graft failure			No
Secondary	Overall survival			No
Secondary	Quality of life			No
Secondary	Time to acute GVHD			No
Secondary	Time to chronic GVHD			No
Secondary	Chronic GVHD details			No
Secondary	Cost			No
Secondary	Detailed donor and patient self-reported outcomes			No