Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis, Acute Myeloid Leukemia, or Myelodysplastic Syndrome

Summary

This trial is studying the side effects and how well giving cyclophosphamide and busulfan followed by donor stem cell transplant works in treating patients with myelofibrosis, acute myeloid leukemia, or myelodysplastic syndrome. Giving chemotherapy, such as cyclophosphamide and busulfan, before a donor stem cell transplant helps stops the growth of cancer 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 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 tacrolimus and methotrexate after the transplant may stop this from happening

Conditions

• 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
• Essential Thrombocythemia
• Myelodysplastic Syndrome With Isolated Del(5q)
• Polycythemia Vera
• Previously Treated Myelodysplastic Syndromes
• Primary Myelofibrosis
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia
• Secondary Myelodysplastic Syndromes
• Secondary Myelofibrosis
• Untreated Adult Acute Myeloid Leukemia
• Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

Interventions

DRUG

cyclophosphamide

Given IV

DRUG

busulfan

Given IV

DRUG

tacrolimus

Given IV or PO

DRUG

methotrexate

Given IV

GENETIC

cytogenetic analysis

Correlative studies

OTHER

flow cytometry

Correlative studies

OTHER

pharmacological study

Correlative studies

OTHER

pharmacogenomic studies

Correlative studies

PROCEDURE

peripheral blood stem cell transplantation

Undergo PBPC transplantation

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic transplantation

Sponsors & Collaborators

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

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Andrew Rezvani · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-12-31

Primary Completion

2011-06-30

Completion

2013-06-30

Countries

• United States

Study Locations