Adult Double Cord Blood Transplant Study

Phase 2

Completed

• Conditions: Cord Blood Stem Cell Transplantation; Hematologic Malignancies
• Interventions: Procedure: Cord blood transplantation

• Registration Number: NCT00514579
• Lead Sponsor: Center for International Blood and Marrow Transplant Research

Brief Summary

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-08
• Study First Submitted QC: 2007-08-09
• Study First Posted: 2007-08-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-07
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Myeloablative double unit UCBT	Cord blood transplantation	Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation

Primary Outcome Measures

Name	Time	Method
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies	One year

Secondary Outcome Measures

Name	Time	Method
Measure incidence and severity of chronic GVHD	1 year
Measure incidence of donor-derived neutrophil and platelet recovery	100 Days
Measure contribution of each unit to initial and sustained engraftment	2 years
Measure incidence and severity of acute graft-versus-host disease	100 Days
Measure incidence of transplant-related mortality	6 months
Measure incidence of malignant relapse	2 years
Measure incidence of serious infectious complications	1 year
Measure incidence of immune reconstitution	2 years
Measure probability of overall and disease-free survival	2 years

Trial Locations

Locations (10)

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

City of Hope; 🇺🇸 Duarte, California, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States

Blood and Marrow Transplant Program at Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States

University of Oklahoma; 🇺🇸 Oklahoma City, Oklahoma, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States