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Clinical Trials in Israel / NCT01351545
Recruiting Observational

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

NCT01351545 · tracked via the Priya Life Science Israel tracker
Sponsor
Center for International Blood and Marrow Transplant Research
Phase
Observational
Started
2011-10
Last updated
2026-07-06

Condition(s) studied

Hematologic MalignanciesInherited Disorders of MetabolismInherited Abnormalities of PlateletsHistiocytic DisordersAcute Myelogenous Leukemia (AML or ANLL)Acute Lymphoblastic Leukemia (ALL)Other Acute LeukemiaChronic Myelogenous Leukemia (CML)Myelodysplastic (MDS) / Myeloproliferative (MPN) DiseasesOther LeukemiaHodgkin LymphomaNon-hodgkin LymphomaMultiple Myeloma/ Plasma Cell Disorder (PCD)Inherited Abnormalities of Erythrocyte Differentiation or FunctionDisorders of the Immune SystemAutoimmune DiseasesSevere Aplastic Anemia

Investigational drug(s) / intervention(s)

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs): A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Neutrophil recovery of ≥500/mm3 after cord blood transplantation — Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.
    The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.
  • Neutrophil recovery of ≥500/mm3 after cord blood transplantation — Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.
    The primary objective of this access and distribution protocol is to examine the incidence of neutrophil recovery of ≥500/mm3 after cord blood transplantation in a multi-institution setting using CBUs that are not FDA licensed.

Trial sites (142)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Banner MD Anderson Cancer Center Gilbert Arizona Recruiting
Phoenix Children's Hospital Phoenix Arizona Recruiting
Mayo Clinic Arizona (adults) Phoenix Arizona Withdrawn
University of Arizona Medical Center - Tucson Tucson Arizona Recruiting
Arkansas Children's Hospital Little Rock Arkansas Recruiting
City of Hope Duarte California Recruiting
Children's Hospital of Los Angeles Glendale California Recruiting
Scripps Green Hospital La Jolla California Recruiting
University of California San Diego La Jolla California Recruiting
Loma Linda University Cancer Center Loma Linda California Recruiting
UCLA Los Angeles California Recruiting
Children's Hospital and Research Center of Oakland Oakland California Active Not Recruiting
Children's Hospital of Orange County (CHOC) Orange California Recruiting
Sutter Medical Center Sacramento California Recruiting
Rady Children's Hospital San Diego San Diego California Recruiting
UCSF (adults) San Francisco California Active Not Recruiting
UCSF (Peds) San Francisco California Recruiting
Stanford University Medical Center Stanford California Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
University of Colorado Hospital Aurora Colorado Recruiting
Presbyterian St. Luke's/Colorado Blood Cancer Institute Denver Colorado Recruiting
Yale New Haven Hospital New Haven Connecticut Recruiting
Nemours - Alfred I. duPont Hospital for Children Brandywine Delaware Recruiting
Children's National Medical Center Washington D.C. District of Columbia Recruiting
University of Florida Shands Medical Center Gainesville Florida Recruiting
Nemours Children's Hospital - Mayo Jacksonville Jacksonville Florida Recruiting
Mayo Clinic - Jacksonville Jacksonville Florida Withdrawn
University of Miami (adult) Miami Florida Active Not Recruiting
University of Miami (peds) Miami Florida Recruiting
Niklaus Children's Hospital Miami Florida Recruiting
AdventHealth Orlando Orlando Florida Recruiting
Florida Center for Pediatric Cellular Therapy Orlando Florida Recruiting
Orlando Health Arnold Palmer Hospital for Children Orlando Florida Recruiting
Orlando Health Cancer Institute Bone Marrow Transplant and Cellular Therapy Orlando Florida Recruiting
All Children's Hospital St. Petersburg Florida Recruiting
H Lee Moffitt Cancer Center Tampa Florida Active Not Recruiting
Children's Healthcare of Atlanta Atlanta Georgia Recruiting
Emory University Hospital Atlanta Georgia Terminated
Northside Hospital Atlanta Georgia Recruiting

+ 102 more sites — see the full list on the official registry below.

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International Study for Treatment of High Risk Childhood Relapsed ALL 2010 Recruiting
Evaluating the Impact of Social and Genetic Factors on Outcomes in Adolescent and Young Adult Cancer Survivors Active, not recruiting
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma Active, not recruiting
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01351545 on ClinicalTrials.gov ↗ ← All trials in Israel