Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia

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

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

Interventions

RADIATION

total-body irradiation

Radiation

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic transplantation

DRUG

cyclophosphamide

Given IV

DRUG

mycophenolate mofetil

Given orally

DRUG

busulfan

Given IV or orally

DRUG

cyclosporine

Given IV or orally

DRUG

fludarabine phosphate

Given IV

PROCEDURE

peripheral blood stem cell transplantation

Undergo transplantation

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

Undergo allogeneic transplantation

OTHER

laboratory biomarker analysis

Correlative studies

GENETIC

cytogenetic analysis

Correlative studies

OTHER

flow cytometry

Correlative studies

GENETIC

fluorescence in situ hybridization

Correlative studies

OTHER

pharmacological study

Correlative studies

GENETIC

polymorphism analysis

Correlative studies

DRUG

tacrolimus

Given IV or orally

DRUG

methotrexate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Bart Scott · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-01-31

Primary Completion

2012-04-30

Completion

2014-10-31

Countries

• United States
• Germany

Study Locations