Adult Double Cord Blood Transplant Study - Full Text View

Sponsor:	Center for International Blood and Marrow Transplant Research
Information provided by:	Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:	NCT00514579

Purpose

The hypothesis of the study is double unit umbilical cord blood transplantation in adults will be associated with a one year survival rate of at least 40%.

Condition	Intervention	Phase
Cord Blood Stem Cell Transplantation Hematologic Malignancies	Procedure: Cord blood transplantation	Phase II

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Center for International Blood and Marrow Transplant Research:

Primary Outcome Measures:

Measure overall survival of double unit UCBT in adult patients with hematologic malignancies [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Measure incidence of donor-derived neutrophil and platelet recovery [ Time Frame: 100 Days ] [ Designated as safety issue: Yes ]
Measure contribution of each unit to initial and sustained engraftment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Measure incidence and severity of acute graft-versus-host disease [ Time Frame: 100 Days ] [ Designated as safety issue: Yes ]
Measure incidence and severity of chronic GVHD [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Measure incidence of transplant-related mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Measure incidence of malignant relapse [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Measure incidence of serious infectious complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Measure incidence of immune reconstitution [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Measure probability of overall and disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	55
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation

Eligibility

Ages Eligible for Study:	22 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 22 - 50 years.
Patients will have one of the following hematological malignancies:
- Acute myelogenous leukemia (AML):
- Acute lymphoblastic leukemia (ALL):
- Acute undifferentiated leukemia (AUL) or biphenotypic leukemia
- Myelodysplastic Syndrome (MDS) with one of the following:
Patients with adequate organ function and performance status criteria
Two Suitable Umbilical Cord Blood Units

Exclusion Criteria:

Patient with suitable related donor
AML, ALL, AUL, biphenotypic leukemia beyond CR2
AML evolved from myelofibrosis
Any acute leukemia with:
- Morphologic relapse or persistent disease in the BM
- Active extra-medullary leukemia including active CNS leukemia
- Requiring greater than two cycles of chemotherapy to obtain present remission status
Bone marrow aplasia (defined as BM cellularity < 5% at transplant work-up)
MDS with 10% or greater bone marrow blasts at pre-transplant workup
Prior autologous or allogeneic HSC transplant at any time
Prior radiation therapy rendering patient ineligible for TBI
Any uncontrolled infection at time of study enrollment
Seropositive or NAT positive for HIV or HTLV1
Females who are pregnant or breast feeding
Patient unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, follow-up, and research tests

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514579

Contacts

Contact: Amy Foley, MA, CCRP	612 884-8605	afoley@nmdp.org
Contact: Rebecca Drexler	612 884-8654	rdrexler@nmdp.org

Locations

United States, California
City of Hope	Recruiting
Duarte, California, United States, 91010
Contact: Chatchada Karanes, MD 626-359-8111 ext 62691 CKaranes@coh.org
Contact: Martha Bellin 626-256-4673 ext 65897 mbellin@coh.org
Principal Investigator: Chatchada Karanes, MD
University of California at Los Angeles	Recruiting
Los Angeles, California, United States, 90095
Contact: Mary Territo, MD 310-825-7768 mterrito@mednet.ucla.edu
Contact: Sandra Edwards 310-825-7768 sedwards@mednet.ucla.edu
Principal Investigator: Mary Territo, MD
United States, Georgia
Blood and Marrow Transplant Program at Northside Hospital	Recruiting
Atlanta, Georgia, United States, 30342
Contact: Scott Solomon, MD 404-255-1930 ssolomon@bmtga.com
Contact: Stacey Brown 404-851-8238 Stacey.Brown@northside.com
Principal Investigator: Scott Solomon, MD
United States, Illinois
Loyola University Medical Center	Recruiting
Maywood, Illinois, United States, 60153
Contact: Patrick Stiff, MD 708-327-3308 pstiff@lumc.edu
Contact: Sandy Zakrzewski 708-327-2831 szakrze@lumc.edu
Principal Investigator: Patrick Stiff, MD
United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Juliet Barker, MBBS 212-639-3468 barkerj@mskcc.org
Contact: Michelle Abboud, RN 212-639-5019 abboudm@mskcc.org
Principal Investigator: Juliet Barker, MBBS
United States, North Carolina
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27710
Contact: Joanne Kurtzberg, MD 919-668-1119 kurtz001@mc.duke.edu
Contact: Dorothy Mazzitelli 919-668-2685 dorothy.mazzitelli@duke.edu
Principal Investigator: Joanne Kurtzberg, MD
United States, Ohio
Case Western Reserve University	Recruiting
Cleveland, Ohio, United States
Contact: Mary Laughlin, MD 216-368-5693 mary.laughlin@case.edu
Contact: Sally Erinc, RN 216-844-5492 Sally.Erinc@uhhospitals.org
Principal Investigator: Mary Laughlin, MD
Ohio State University Medical Center	Recruiting
Columbus, Ohio, United States, 43210
Contact: Deanna Black 614-293-7589 Deanna.Black@osumc.edu
Contact: Steve Devine, MD (614) 293-5655 Steven.Devine@osumc.edu
Principal Investigator: Steven Devine, MD
United States, Oklahoma
University of Oklahoma	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: George Selby, MD 405-271-4022 George-Selby@ouhsc.edu
Contact: Jennifer Holter, MD 405-271-4022 Jennifer-Holter@ouhsc.edu
Principal Investigator: George Selby, MD
Sub-Investigator: Jennifer Holter, MD
United States, Texas
Texas Transplant Institute	Recruiting
San Antonio, Texas, United States, 78229
Contact: Carlos Bachier, MD 210-575-8631 Carlos.Bachier@MHShealth.com
Contact: Maureen Hougham, RN 210-575-4035 maureen.hougham@mhshealth.com
Principal Investigator: Carlos Bachier, MD
United States, Wisconsin
University of Wisconsin-Madison	Recruiting
Madison, Wisconsin, United States
Contact: Mark Juckett, MD 608-265-8690 mbj@medicine.wisc.edu
Contact: Jae Werndli 608-262-7202 jw6@medicine.wisc.edu
Principal Investigator: Mark Juckett, MD

Sponsors and Collaborators

Center for International Blood and Marrow Transplant Research

Investigators

Principal Investigator:

Juliet Barker, MBBS

Memorial Sloan-Kettering Cancer Center

More Information

No publications provided

Responsible Party:	Roberta King, MPH Vice President of CIBMTR, National Marrow Donor Program
ClinicalTrials.gov Identifier:	NCT00514579 History of Changes
Other Study ID Numbers:	05-DCB
Study First Received:	August 8, 2007
Last Updated:	March 5, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Center for International Blood and Marrow Transplant Research:

Cord Blood Stem Cell Transplantation
Hematologic Malignancies
Leukemia
Myelodysplastic Syndrome

Additional relevant MeSH terms:

Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012