RecruitingNot Applicable

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

United States99,999 participantsStarted 2011-10

Plain-language summary

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment * Signed informed consent (and signed assent, if applicable) obtained prior to study enrollment * Pediatric and adult patients of any age Exclusion Criteria: * Patients who are receiving only licensed CBUs * Cord blood transplant recipients at international transplant centers * Patients who are enrolled on another IND protocol to access the unlicensed CBU(s) * Patients whose selected unlicensed CBU(s) will be more than minimally manipulated

What they're measuring

Neutrophil recovery of ≥500/mm3 after cord blood transplantation

Timeframe: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.

Neutrophil recovery of ≥500/mm3 after cord blood transplantation

Timeframe: Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.

Trial details

NCT IDNCT01351545

SponsorCenter for International Blood and Marrow Transplant Research

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2041-10

Contact for this trial

Elizabeth Fosberg, B.A.

10-CBA@ndmp.org

View on ClinicalTrials.gov More Hematologic Malignancies trials