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Adult Double Cord Blood Transplant Study

Primary Purpose

Cord Blood Stem Cell Transplantation, Hematologic Malignancies

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cord blood transplantation
Sponsored by
Center for International Blood and Marrow Transplant Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cord Blood Stem Cell Transplantation focused on measuring Cord Blood Stem Cell Transplantation, Hematologic Malignancies, Leukemia, Myelodysplastic Syndrome

Eligibility Criteria

22 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope
  • University of California at Los Angeles
  • H. Lee Moffitt Cancer Center and Research Institute
  • Blood and Marrow Transplant Program at Northside Hospital
  • Memorial Sloan Kettering Cancer Center
  • Duke University Medical Center
  • Case Western Reserve University
  • Ohio State University Medical Center
  • University of Oklahoma
  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Myeloablative double unit UCBT

Arm Description

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

Outcomes

Primary Outcome Measures

Measure overall survival of double unit UCBT in adult patients with hematologic malignancies

Secondary Outcome Measures

Measure incidence of donor-derived neutrophil and platelet recovery
Measure contribution of each unit to initial and sustained engraftment
Measure incidence and severity of acute graft-versus-host disease
Measure incidence and severity of chronic GVHD
Measure incidence of transplant-related mortality
Measure incidence of malignant relapse
Measure incidence of serious infectious complications
Measure incidence of immune reconstitution
Measure probability of overall and disease-free survival

Full Information

First Posted
August 8, 2007
Last Updated
March 7, 2014
Sponsor
Center for International Blood and Marrow Transplant Research
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1. Study Identification

Unique Protocol Identification Number
NCT00514579
Brief Title
Adult Double Cord Blood Transplant Study
Official Title
A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for International Blood and Marrow Transplant Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cord Blood Stem Cell Transplantation, Hematologic Malignancies
Keywords
Cord Blood Stem Cell Transplantation, Hematologic Malignancies, Leukemia, Myelodysplastic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myeloablative double unit UCBT
Arm Type
Other
Arm Description
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Intervention Type
Procedure
Intervention Name(s)
Cord blood transplantation
Intervention Description
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation
Primary Outcome Measure Information:
Title
Measure overall survival of double unit UCBT in adult patients with hematologic malignancies
Time Frame
One year
Secondary Outcome Measure Information:
Title
Measure incidence of donor-derived neutrophil and platelet recovery
Time Frame
100 Days
Title
Measure contribution of each unit to initial and sustained engraftment
Time Frame
2 years
Title
Measure incidence and severity of acute graft-versus-host disease
Time Frame
100 Days
Title
Measure incidence and severity of chronic GVHD
Time Frame
1 year
Title
Measure incidence of transplant-related mortality
Time Frame
6 months
Title
Measure incidence of malignant relapse
Time Frame
2 years
Title
Measure incidence of serious infectious complications
Time Frame
1 year
Title
Measure incidence of immune reconstitution
Time Frame
2 years
Title
Measure probability of overall and disease-free survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliet Barker, MBBS
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Blood and Marrow Transplant Program at Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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Adult Double Cord Blood Transplant Study

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