Clinical trial NCT00322101: Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Official title: A Multi-center Phase III Study Comparing Myeloablative to Nonmyeloablative Transplant Conditioning in Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
Conditions: Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
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)
Childhood Acute Myeloid Leukemia in Remission
Childhood Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes
Myelodysplastic Syndrome With Isolated Del(5q)
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Secondary Acute Myeloid Leukemia
Secondary Myelodysplastic Syndromes
Summary: RATIONALE: Giving chemotherapy, such as fludarabine phosphate, busulfan, and cyclophosphamide, and total-body radiation therapy before a donor peripheral stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. It is not yet known whether low-dose chemotherapy and total-body radiation therapy is more effective than high-dose chemotherapy in treating patients with myelodysplastic syndrome or acute myeloid leukemia.
PURPOSE: This phase III trial is studying low-dose conditioning to see how well it works compared to high-dose conditioning followed by peripheral blood stem cell transplant in treating patients with myelodysplastic syndromes or acute myeloid leukemia
Interventions:
description: Radiation
name: total-body irradiation
other_name: TBI
type: Radiation
description: Undergo allogeneic transplantation
name: allogeneic hematopoietic stem cell transplantation
type: Procedure
description: Given IV
name: cyclophosphamide
other_name: CPM
CTX
Cytoxan
Endoxan
Endoxana
type: Drug
description: Given orally
name: mycophenolate mofetil
other_name: Cellcept
MMF
type: Drug
description: Given IV or orally
name: busulfan
other_name: BSF
BU
Misulfan
Mitosan
Myeloleukon
type: Drug
description: Given IV or orally
name: cyclosporine
other_name: CYSP
Sandimmune
ciclosporin
cyclosporin
cyclosporin A
type: Drug
description: Given IV
name: fludarabine phosphate
other_name: 2-F-ara-AMP
Beneflur
Fludara
type: Drug
description: Undergo transplantation
name: peripheral blood stem cell transplantation
other_name: PBPC transplantation
PBSC transplantation
peripheral blood progenitor cell transplantation
transplantation, peripheral blood stem cell
type: Procedure
description: Undergo allogeneic transplantation
name: nonmyeloablative allogeneic hematopoietic stem cell transplantation
type: Procedure
description: Correlative studies
name: laboratory biomarker analysis
type: Other
description: Correlative studies
name: cytogenetic analysis
type: Genetic
description: Correlative studies
name: flow cytometry
type: Other
description: Correlative studies
name: fluorescence in situ hybridization
other_name: fluorescence in situ hybridization (FISH)
type: Genetic
description: Correlative studies
name: pharmacological study
other_name: pharmacological studies
type: Other
description: Correlative studies
name: polymorphism analysis
type: Genetic
description: Given IV or orally
name: tacrolimus
other_name: FK 506
Prograf
type: Drug
description: Given IV
name: methotrexate
other_name: Folex
MTX
Mexate
amethopterin
methylaminopterin
type: Drug
Study arms:
design_group_description: CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.<br/>TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.<br/>GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
design_group_title: Arm I (Nonmyeloablative regimen)
design_group_type: Experimental
design_group_description: CONDITIONING: Patients are assigned to 1 of 2 treatment groups.<br/>Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.<br/>Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.<br/>TRANSPLANTATION: Patients undergo PBSC infusion on day 0.<br/>GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
design_group_title: Arm II (Myeloablative regimen)
design_group_type: Experimental
Sponsor: Fred Hutchinson Cancer Research Center
Collaborators: National Heart, Lung & Blood Institute
National Cancer Institute
Drug name mappings:
name: 环孢素
lang: CN
name: Cyclosporine
lang: EN
name: シクロスポリン
lang: JP
name: 磷酸氟达拉滨
lang: CN
name: Fludarabine Phosphate
lang: EN
name: フルダラビンリン酸エステル
lang: JP
name: 白消安
lang: CN
name: Busulfan
lang: EN
name: ブスルファン
lang: JP
name: 环磷酰胺
lang: CN
name: Cyclophosphamide
lang: EN
name: シクロホスファミド水和物
lang: JP
name: 他克莫司
lang: CN
name: Tacrolimus
lang: EN
name: タクロリムス水和物
lang: JP
name: 吗替麦考酚酯
lang: CN
name: Mycophenolate Mofetil
lang: EN
name: ミコフェノール酸 モフェチル
lang: JP
name: 甲氨蝶呤
lang: CN
name: Methotrexate
lang: EN
name: メトトレキサート
lang: JP