Summary

Location
at Oakland, California and other locations
Dates
study started
completion around
Principal Investigator
by Thomas Martin
Headshot of Thomas Martin
Thomas Martin

Description

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.

Official Title

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

Details

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

Keywords

Hematologic Malignancies, Inherited Disorders of Metabolism, Inherited Abnormalities of Platelets, Histiocytic Disorders, Acute Myelogenous Leukemia (AML or ANLL), Acute Lymphoblastic Leukemia (ALL), Other Acute Leukemia, Chronic Myelogenous Leukemia (CML), Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases, Other Leukemia, Hodgkin Lymphoma, Non-hodgkin Lymphoma, Multiple Myeloma/ Plasma Cell Disorder (PCD), Inherited Abnormalities of Erythrocyte Differentiation or Function, Disorders of the Immune System, Autoimmune Diseases, Severe Aplastic Anemia, Lymphoma, Leukemia, Multiple Myeloma, Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myeloid Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Hematologic Neoplasms, Leukemia, Myeloid, Acute, Aplastic Anemia, Congenital Abnormalities, Unlicensed CBU

Eligibility

You can join if…

  • 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

You CAN'T join if...

  • 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

Locations

  • Children's Hospital and Research Center of Oakland accepting new patients
    Oakland California 94609 United States
  • UCSF (adults) currently not accepting new patients, but might later
    San Francisco California 94143 United States
  • UCSF (peds) currently not accepting new patients, but might later
    San Francisco California 94143 United States
  • Stanford University Medical Center accepting new patients
    Stanford California 94304 United States

Lead Scientist at UCSF

  • Thomas Martin
    A leading expert in hematology-oncology, Dr. Thomas Martin is associate director of UCSF's myeloma program and director of the unrelated donor transplantation programs for adults at UCSF Medical Center. Martin is clinical research director of hematologic malignancies (blood cancers) at the UCSF Helen Diller Family Comprehensive Cancer Center.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Center for International Blood and Marrow Transplant Research
ID
NCT01351545
Study Type
Observational
Participants
Expecting 99999 study participants
Last Updated