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

Trial Information

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

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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

Principal Investigator

Stephen Couban, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Care Nova Scotia

Authority:

Unspecified

Study ID:

CDR0000528289

NCT ID:

NCT00438958

Start Date:

March 2007

Completion Date:

Related Keywords:

Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Secondary Myelofibrosis
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
Primary Myelofibrosis
Graft vs Host Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Lymphoma, Large-Cell, Immunoblastic

Name	Location
Fred Hutchinson Cancer Research Center	Seattle, Washington 98109

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