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

ConditionsHematologic 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
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCenter for International Blood and Marrow Transplant Research

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Recipients of unlicensed cryopreserved cord blood units who are being treated as U.S. transplant centers.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

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

    Drug

    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

Treatment groups

99,999 Participants
are divided into 1 treatment group
Group A: Unlicensed CBU1 intervention

Trial outcomes

Primary outcomes

1

Neutrophil recovery of ≥500/mm3 after cord blood transplantation

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.

Time frame
Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.
2

Neutrophil recovery of ≥500/mm3 after cord blood transplantation

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for International Blood and Marrow Transplant Research

Lead sponsor

National Marrow Donor Program

Collaborator

Source ClinicalTrials.gov
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