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

Hodgkin Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01351545
• Other study ID #: 10-CBA
• Status: Recruiting
• Start date: October 2011
• Est. completion date: October 2041

Study information

• Verified date: June 2024
• Source: Center for International Blood and Marrow Transplant Research
• Contact: Shannon Clark, MS
• Email: 10-CBA[@]ndmp.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Other known NCT identifiers

• NCT01553461

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99999
• Est. completion date: October 2041
• Est. primary completion date: October 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Childrens Hospital Medical Center of Akron	Akron	Ohio
United States	Amarillo Blood and Marrow Transplant Program	Amarillo	Texas
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of Colorado Hospital	Aurora	Colorado
United States	Greenebaum Cancer Center - University of Maryland	Baltimore	Maryland
United States	Johns Hopkins	Baltimore	Maryland
United States	Indiana Blood & Marrow Transplantation	Beech Grove	Indiana
United States	NIH/NCI	Bethesda	Maryland
United States	Nih/Nhlbi	Bethesda	Maryland
United States	Nih/Niaid	Bethesda	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Nemours - Alfred I. duPont Hospital for Children	Brandywine	Delaware
United States	Children's Hospital at Montefiore	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Levine Children's Hospital	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	The Jewish Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	The Arthur G. James Cancer Hospital/The Ohio State University Medical Center	Columbus	Ohio
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Medical City Dallas	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Presbyterian St. Luke's/Colorado Blood Cancer Institute	Denver	Colorado
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Henry Ford Health System	Detroit	Michigan
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Zachary & Elizabeth Fisher Bone Marrow Transplant Program (Brooke Army Medical Center)	Fort Sam Houston	Texas
United States	Cook Children's Hospital	Fort Worth	Texas
United States	University of Florida Shands Medical Center	Gainesville	Florida
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Children's Hospital of Los Angeles	Glendale	California
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan
United States	Spectrum Health	Grand Rapids	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Penn State Milton S. Hershey Cancer Center	Hershey	Pennsylvania
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Texas Children's Hospital - Baylor Medical Center	Houston	Texas
United States	Indiana University/Riley Hospital for Children	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Univeristy of Mississippi Medical Center	Jackson	Mississippi
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	Nemours Children's Hospital - Mayo Jacksonville	Jacksonville	Florida
United States	Children's Mercy Hospital and Clinics	Kansas City	Missouri
United States	Scripps Green Hospital	La Jolla	California
United States	University of California San Diego	La Jolla	California
United States	North Shore University Hospital	Lake Success	New York
United States	Loma Linda University Cancer Center	Loma Linda	California
United States	UCLA	Los Angeles	California
United States	University of Louisville Hospital - James Brown Cancer Center	Louisville	Kentucky
United States	Southwest Cancer Treatment & Research Center	Lubbock	Texas
United States	University of Wisconsin - Madison	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Methodist Healthcare Blood and Marrow Transplant Center	Memphis	Tennessee
United States	St. Jude Childrens Research Hospital	Memphis	Tennessee
United States	Niklaus Children's Hospital	Miami	Florida
United States	University of Miami (adult)	Miami	Florida
United States	University of Miami (peds)	Miami	Florida
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	West Virginia University	Morgantown	West Virginia
United States	Sarah Cannon BMT Program	Nashville	Tennessee
United States	VA Tennessee Valley Healthcare System	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Robert Wood Johnson/Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Cohen Children's Medical Center of New York	New Hyde Park	New York
United States	Children's Hospital of New Orleans/LSUHSC	New Orleans	Louisiana
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Columbia University Medical Center - Morgan Stanley Children's Hospital	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	New York Presbyterian Hospital at Cornell	New York	New York
United States	New York University Langone Medical Center	New York	New York
United States	Westchester Medical Center	New York	New York
United States	Children's Hospital and Research Center of Oakland	Oakland	California
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Children's Hospital of Orange County (CHOC)	Orange	California
United States	AdventHealth Orlando	Orlando	Florida
United States	Florida Center for Pediatric Cellular Therapy	Orlando	Florida
United States	Orlando Health Bone Marrow Transplant and Cellular Therapy	Orlando	Florida
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona (adults)	Phoenix	Arizona
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Pennsylvania/Thomas Jefferson	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Western Penn Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University/Doernbecher Children's Hospital	Portland	Oregon
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Strong Memorial Hospital/University of Rochester	Rochester	New York
United States	Sutter Medical Center	Sacramento	California
United States	Cardinal Glennon Children's Medical Center	Saint Louis	Missouri
United States	St. Louis University Medical Center	Saint Louis	Missouri
United States	Washington University St. Louis	Saint Louis	Missouri
United States	Washington University/St. Louis Children's Hospital	Saint Louis	Missouri
United States	All Children's Hospital	Saint Petersburg	Florida
United States	University of Utah	Salt Lake City	Utah
United States	Methodist Healthcare System of San Antonio/Texas Transplant Institute	San Antonio	Texas
United States	The Children's Hospital of San Antonio	San Antonio	Texas
United States	Rady Children's Hospital San Diego	San Diego	California
United States	UCSF (adults)	San Francisco	California
United States	UCSF (peds)	San Francisco	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	VA Puget Sound HCS	Seattle	Washington
United States	Avera Transplant Institute	Sioux Falls	South Dakota
United States	Stanford University Medical Center	Stanford	California
United States	Stony Brook University Hospital	Stony Brook	New York
United States	H Lee Moffitt Cancer Center	Tampa	Florida
United States	University of Arizona Medical Center - Tucson	Tucson	Arizona
United States	Children's National Medical Center	Washington	District of Columbia
United States	University of Kansas	Westwood	Kansas
United States	Wake Forest University	Winston-Salem	North Carolina
United States	University of Massachusetts	Worcester	Massachusetts
United States	Midwestern Regional Medical Center	Zion	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Center for International Blood and Marrow Transplant Research	National Marrow Donor Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 60 days post-transplant.
Primary	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.	Cord blood engraftment occurs in weeks following transplant is defined as defined as ANC 500/mm3 and is analyzed at 100 days post-transplant.