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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


Phase 3
16 Years
65 Years
Open (Enrolling)
Both
Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia, Lymphoma, Myelodysplastic Syndromes, Secondary Myelofibrosis

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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:

No

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 CenterSeattle, Washington  98109