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

  • STATUS
    Recruiting
  • End date
    Oct 21, 2041
  • participants needed
    99999
  • sponsor
    Center for International Blood and Marrow Transplant Research
Updated on 21 June 2021
cancer
hematologic malignancy

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.

Description

Principal Investigators:

The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers.

Study Design:

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.

Primary Objective:

The primary objective of this study 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 Food and Drug Administration (FDA) licensed.

Secondary Objectives:

In patients receiving a non-licensed CBU:

  • Assess incidence of transmission of infection
  • Assess incidence of serious infusion reaction
  • Determine 1 year overall survival after cord blood transplantation
  • Assess cumulative incidence of acute graft vs. host disease (GVHD) grades II to IV and grades III to IV
  • Assess cumulative incidence of chronic GVHD
  • Determine platelet engraftment of >20,000 mcL and >50,000 mcL

Details
Condition Bone marrow disorder, childhood ALL, Hodgkin's Disease, Hematologic Malignancy, Blood disorder, Lymphoma, Autoimmune disease, Acute myeloid leukemia, Myelodysplastic-Myeloproliferative Diseases, Autoimmunity, Lymphoma, Chronic myeloid leukemia, Non-Hodgkin's Lymphoma, Acute Myelogenous Leukemia (AML), Severe Aplastic Anemia, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Other Acute Leukemia, Other Leukemia, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Automimmune Diseases, Myelodysplastic/Myeloproliferative Neoplasms, Lymphocytic Leukemia, Acute, Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Blood Cancer, Hematologic Cancer, Hematological Disorders, Hematologic Neoplasms, Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), acute lymphoblastic leukemia, leukemia, acute lymphoblastic, myelodysplastic/myeloproliferative neoplasm, myeloproliferative/myelodysplastic disorders, mds/mpd, non-hodgkin's lymphoma (nhl), autoimmune diseases, autoimmune disorder, autoimmune disorders, hodgkin, hodgkin's lymphomas, hodgkin lymphomas, hodgkins lymphoma, hodgkin's lymphoma, acute lymphoid leukaemia, acute lymphocytic leukemia, acute lymphoblastic leukemia (all), acute myelogenous leukemia, anll, acute myeloblastic leukemia, chronic myelogenous leukemia, hematological malignancy, hematologic malignancies, hematological tumor, haematological malignancy, hematological malignancies, Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD), Multiple Myeloma/ Plasma Cell Disorder (PCD)
Treatment A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs)
Clinical Study IdentifierNCT01351545
SponsorCenter for International Blood and Marrow Transplant Research
Last Modified on21 June 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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