CompletedPhase 3

Single vs Double Umbilical Cord Blood Transplants in Children With High Risk Leukemia and Myelodysplasia (BMT CTN 0501)

United States224 participantsStarted 2006-12

Plain-language summary

This study is a Phase III, randomized, open-label, multi-center, prospective study of single umbilical cord blood (UCB) transplantation versus double UCB transplantation in pediatric patients with hematologic malignancies.

Who can participate

Age range1 Year – 21 Years

SexALL

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Inclusion criteria

✓. High risk first complete remission (CR1), defined as the following:
✓. Second or greater CR
✓. First relapse with less than 25% blasts in bone marrow
✓. Morphologic complete remission with incomplete blood count recovery
✓. High risk first remission, defined as one of the following conditions:
✓. High risk second remission, defined as one of the following conditions:
✓. Any third or subsequent CR
✓. Cardiac: Left ventricular ejection fraction greater than 40% or shortening fraction greater than 26%

What they're measuring

Percentage of Participants With Overall Survival

Timeframe: 1 year post-randomization

Trial details

NCT IDNCT00412360

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

Results submitted2015-08-28

View on ClinicalTrials.gov More Acute Myelogenous Leukemia trials