At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 97 enrolled

Drug / intervention

Fludarabine +3 moredrug

Likely dose

Cyclophosphamide 150mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00326417

NCT00326417Phase 2Completed

Compare CT.gov

Fludarabine-based Conditioning for Allogeneic Marrow Transplantation From HLA-compatible Unrelated Donors in Severe Aplastic Anemia (BMT CTN #0301)

Medical College of Wisconsin·interventional·Posted May 16, 2006·Updated Oct 28, 2021

In Brief

A Phase 2 clinical trial evaluating Fludarabine, Cyclophosphamide 150mg, and 2 other interventions for Anemia, Aplastic. Completed, enrolled 97 participants across 22 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnemia, Aplastic

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), Blood and Marrow Transplant Clinical Trials Network, National Cancer Institute (NCI), National Marrow Donor Program

Timeline

Phase 2CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2006

First PostedMay 2006

Primary CompletionSep 2015

Study CompletionJan 2016

TodayJul 2026

First PostedMay 16, 2006

Enrollment StartJan 1, 2006

Primary CompletionSep 1, 2015

Study CompletionJan 1, 2016

TodayJul 2, 2026

Enrollment to primary: 9.7 yearsPosted 20.1 years ago

Interventions

Fludarabinedrug

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

Cyclophosphamide 150mgdrug

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

Cyclophosphamide 100mgdrug

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

Cyclophosphamide 50mgdrug

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