MedTrace Logo

Treo/Flu/TBI With Donor Stem Cell Transplant for Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

NCT01894477 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-06-03

Study results available
· View outcomes & findings →

Summary

This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor 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. 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 before and mycophenolate mofetil after the transplant may stop this from happening.

Conditions

  • Acute Myeloid Leukemia in Remission
  • Chronic Myelomonocytic Leukemia
  • Minimal Residual Disease
  • Myelodysplastic Syndrome
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable

Interventions

PROCEDURE

Allogeneic Bone Marrow Transplantation

Undergo allogeneic bone marrow transplant

DRUG

Fludarabine Phosphate

Intravenously administered Fludarabine Phosphate

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSC transplant

RADIATION

Total-Body Irradiation

Undergo TBI

DRUG

Treosulfan

Intravenously administered Treosulfan

OTHER

Laboratory Biomarker Analysis

Correlative Studies

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

  • H. Joachim Deeg · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-01-09
Completion
2022-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01894477 on ClinicalTrials.gov