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

NCT00438958 | Completed Phase 3

• 2 other identifiers: CDR0000528289CBMTG-0601
• Study Type: interventional
• Target: 230
• Locations: 5 countries
• Sites: 16

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

• Time to neutrophil recovery

• Primary graft failure

• Overall survival

• Quality of life

• Time to acute GVHD

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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

Biological: filgrastim; Procedure: peripheral blood stem cell transplantation

Arm II

EXPERIMENTAL

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

Biological: filgrastim; Procedure: allogeneic bone marrow transplantation

Interventions

filgrastim BIOLOGICAL

Given on day 0.

Arm I; Arm II

allogeneic bone marrow transplantation PROCEDURE

Given on day 0

Arm II

peripheral blood stem cell transplantation PROCEDURE

Given on day 0

Arm I

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Canadian Blood and Marrow Transplant Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Institute of Medical and Veterinary Science

Adelaide, South Australia, 5000, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Vancouver Hospital and Health Science Center

Vancouver, British Columbia, V5Z 4E3, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Cancer Care Nova Scotia

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 465, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Royal Victoria Hospital - Montreal

Montreal, Quebec, H3A 1A1, Canada

Location

Hopital de L'Enfant Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Auckland City Hospital

Auckland, 1, New Zealand

Location

King Faisal Specialist Hospital and Research Center

Riyadh, 11211, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 28935847 DERIVED

MeSH Terms

Conditions

Myeloproliferative Disorders; Graft vs Host Disease; Leukemia; Lymphoma; Myelodysplastic Syndromes; Congenital Abnormalities; Leukemia, Myeloid, Accelerated Phase; Leukemia, Myeloid, Chronic-Phase; Anemia, Refractory, with Excess of Blasts; Anemia, Refractory; Leukemia, Myelomonocytic, Chronic; Leukemia, Lymphocytic, Chronic, B-Cell; Primary Myelofibrosis; Lymphoma, B-Cell, Marginal Zone; Burkitt Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma, Large-Cell, Immunoblastic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, T-Cell, Cutaneous; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Mycosis Fungoides; Sezary Syndrome; Waldenstrom Macroglobulinemia

Interventions

Filgrastim; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia; Myelodysplastic-Myeloproliferative Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoma, B-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, T-Cell; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Stephen Couban, MD

  Cancer Care Nova Scotia

  STUDY CHAIR

• Jeffrey H. Lipton, MD, PhD

  Princess Margaret Hospital, Canada

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 22, 2007
• Study Start: March 1, 2007
• Last Updated: March 5, 2014

Record last verified: 2009-07

Locations

SA (1); NZ (1); US (1); AU (2); CA (11)