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

August 8, 2007
March 7, 2014
August 2007
August 2013   (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 ]
Not Provided
Not Provided
 
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%.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cord Blood Stem Cell Transplantation
  • Hematologic Malignancies
Procedure: Cord blood transplantation
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Myeloablative double unit UCBT
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Intervention: Procedure: Cord blood transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
August 2013
August 2013   (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): 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
Both
22 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00514579
05-DCB
Yes
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
Not Provided
Principal Investigator: Juliet Barker, MBBS Memorial Sloan-Kettering Cancer Center
Center for International Blood and Marrow Transplant Research
March 2014

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