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Adult Double Cord Blood Transplant Study
This study is currently recruiting participants.
Study NCT00514579   Information provided by Center for International Blood and Marrow Transplant Research
First Received: August 8, 2007   Last Updated: October 23, 2009   History of Changes

August 8, 2007
October 23, 2009
August 2007
August 2012   (final data collection date for primary outcome measure)
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies [ Time Frame: One year ] [ Designated as safety issue: Yes ]
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies [ Time Frame: One year ]
Complete list of historical versions of study NCT00514579 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measure incidence of donor-derived neutrophil and platelet recovery [ Time Frame: 100 Days ]
  • Measure contribution of each unit to initial and sustained engraftment [ Time Frame: 2 years ]
  • Measure incidence and severity of acute graft-versus-host disease [ Time Frame: 100 Days ]
  • Measure incidence and severity of chronic GVHD [ Time Frame: 1 year ]
  • Measure incidence of transplant-related mortality [ Time Frame: 6 months ]
  • Measure incidence of malignant relapse [ Time Frame: 2 years ]
  • Measure incidence of serious infectious complications [ Time Frame: 1 year ]
  • Measure incidence of immune reconstitution [ Time Frame: 2 years ]
  • Measure probability of overall and disease-free survival [ Time Frame: 2 years ]
 
Adult Double Cord Blood Transplant Study
A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy

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%.

 
Phase II
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Cord Blood Stem Cell Transplantation
  • Hematologic Malignancies
Procedure: Cord blood transplantation
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
55
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
22 Years to 50 Years
No
Contact: Amy Foley, MA, CCRP 612 884-8605 afoley@nmdp.org
Contact: Rebecca Drexler 612 884-8654 rdrexler@nmdp.org
United States
 
NCT00514579
Roberta King, MPH Vice President of CIBMTR, National Marrow Donor Program
05-DCB
Center for International Blood and Marrow Transplant Research
 
Principal Investigator: Juliet Barker, MBBS Memorial Sloan-Kettering Cancer Center
Center for International Blood and Marrow Transplant Research
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP