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Fludarabine-based Conditioning for Severe Aplastic Anemia (BMT CTN 0301)

NCT00326417 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2021-10-28

Study results available
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Summary

The purpose of the current study is to continue to optimize conditioning regimens in high-risk patients with severe aplastic anemia transplanted with marrow from HLA-compatible unrelated donors. Specifically, the study will determine whether the addition of fludarabine to the conditioning regimen previously described by Deeg et al. will permit a reduction in the CY dose, to a point where sustained hematopoietic engraftment and survival are maintained (or improved), while the frequency of major regimen-related toxicity (RRT) and early deaths is reduced.

Conditions

  • Anemia, Aplastic

Interventions

DRUG

Fludarabine

Doses of 30 mg/m\^2 IV will be given for no less than 30 minutes daily for 4 days (Days -5 to -2)

DRUG

Cyclophosphamide 150mg

A total dose of 150 mg/kg will be given as 50 mg/kg per day for 3 days (Days -4, -3, -2)

DRUG

Cyclophosphamide 100mg

A total dose of 100 mg/kg will be given as 50 mg/kg per day for 2 days (Days -3, -2)

DRUG

Cyclophosphamide 50mg

A total dose of 50 mg/kg will be given once at 50 mg/kg per day on Day -2

Sponsors & Collaborators

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

    collaborator NIH

  • Blood and Marrow Transplant Clinical Trials Network

    collaborator NETWORK

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Marrow Donor Program

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Mary Horowitz, MD · Center for International Blood and Marrow Transplant Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2015-09-30
Completion
2016-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00326417 on ClinicalTrials.gov