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| ID | Type | Description | Link |
|---|---|---|---|
| CBMTG-0601 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
OBJECTIVES:
Primary
Secondary
Tertiary
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients undergo filgrastim (G-CSF)-mobilized sibling donor peripheral blood SCT on day 0. |
|
| Arm II | Experimental | Patients undergo G-CSF-mobilized sibling donor bone marrow transplantation on day 0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | Given on day 0. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to neutrophil recovery | ||
| Primary graft failure | ||
| Overall survival |
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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:
Other hematologic malignancy for which sibling donor stem cell transplantation with a myeloablative conditioning regimen is appropriate, including any of the following:
HLA-matched sibling donor available meeting all of the following criteria:
6/6 HLA match
Not identical twin with patient
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Couban, MD | Cancer Care Nova Scotia | Study Chair |
| Jeffrey H. Lipton, MD, PhD | Princess Margaret Hospital, Canada |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-1024 | United States | ||
| Institute of Medical and Veterinary Science |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28935847 | Derived | 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. |
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| allogeneic bone marrow transplantation |
| Procedure |
Given on day 0 |
|
| peripheral blood stem cell transplantation | Procedure | Given on day 0 |
|
| Quality of life |
| Time to acute GVHD |
| Time to chronic GVHD |
| Chronic GVHD details |
| Cost |
| Detailed donor and patient self-reported outcomes |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| Vancouver Hospital and Health Science Center | Vancouver | British Columbia | V5Z 4E3 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Cancer Care Nova Scotia | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| London Regional Cancer Program at London Health Sciences Centre | London | Ontario | N6A 465 | Canada |
| Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | H1T 2M4 | Canada |
| Royal Victoria Hospital - Montreal | Montreal | Quebec | H3A 1A1 | Canada |
| Hopital de L'Enfant Jesus | Québec | Quebec | G1J 1Z4 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| Auckland City Hospital | Auckland | 1 | New Zealand |
| King Faisal Specialist Hospital and Research Center | Riyadh | 11211 | Saudi Arabia |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D006086 | Graft vs Host Disease |
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D009190 | Myelodysplastic Syndromes |
| D000013 | Congenital Abnormalities |
| D015465 | Leukemia, Myeloid, Accelerated Phase |
| D015466 | Leukemia, Myeloid, Chronic-Phase |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| D000753 | Anemia, Refractory |
| D015477 | Leukemia, Myelomonocytic, Chronic |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D055728 | Primary Myelofibrosis |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D002051 | Burkitt Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| D016400 | Lymphoma, Large-Cell, Immunoblastic |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008224 | Lymphoma, Follicular |
| D020522 | Lymphoma, Mantle-Cell |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| D008258 | Waldenstrom Macroglobulinemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D007951 | Leukemia, Myeloid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000740 | Anemia |
| D054437 | Myelodysplastic-Myeloproliferative Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D016393 | Lymphoma, B-Cell |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016399 | Lymphoma, T-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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