Adult Double Cord Blood Transplant Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT00514579
First received: August 8, 2007
Last updated: March 7, 2014
Last verified: March 2014
  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 2

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:


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 ]

Enrollment: 56
Study Start Date: August 2007
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Myeloablative double unit UCBT
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Procedure: Cord blood transplantation
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): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
    • Acute lymphoblastic leukemia (ALL): Complete first remission (CR1) at high risk for relapse or Complete second remission (CR2)
    • Acute undifferentiated leukemia (AUL) or biphenotypic leukemia: CR1 or CR2
    • Myelodysplastic Syndrome (MDS) with one of the following: Low and Intermediate-1 International Prognostic Scoring System (IPSS) score with Life-threatening neutropenia or thrombocytopenia; or Platelet transfusion dependence Intermediate-2 or High IPSS score Therapy-related disease: patient with history of chemotherapy and current evidence of MDS
  • Patients with adequate organ function and performance status criteria
  • Two Suitable Umbilical Cord Blood Units: a cryopreserved dose of at least 1.5 x 107 TNC/kg. If the unit contains red cells at time of cryopreservation, the cryopreserved dose must be at least 2.0 x 107 TNC/kg. Each unit must be at least 4/6 HLA-A and B antigen, and DRB1 allele matched with the recipient. Each unit must be at least 3/6 HLA-A, B DRB1 antigen matched to each other.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
City of Hope
Duarte, California, United States, 91010
University of California at Los Angeles
Los Angeles, California, United States, 90095
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Blood and Marrow Transplant Program at Northside Hospital
Atlanta, Georgia, United States, 30342
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53792
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: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT00514579     History of Changes
Other Study ID Numbers: 05-DCB
Study First Received: August 8, 2007
Last Updated: March 7, 2014
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 July 22, 2014