Adult Double Cord Blood Transplant Study

Sponsor

Center for International Blood and Marrow Transplant Research (Other)

Overall Status

Completed

CT.gov ID

NCT00514579

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

5.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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%.

Condition or Disease	Intervention/Treatment	Phase
Cord Blood Stem Cell Transplantation Hematologic Malignancies	Procedure: Cord blood transplantation	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Measure overall survival of double unit UCBT in adult patients with hematologic malignancies [One year]

Secondary Outcome Measures

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 and severity of chronic GVHD [1 year]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope	Duarte	California	United States	91010
2	University of California at Los Angeles	Los Angeles	California	United States	90095
3	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612
4	Blood and Marrow Transplant Program at Northside Hospital	Atlanta	Georgia	United States	30342
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
6	Duke University Medical Center	Durham	North Carolina	United States	27710
7	Case Western Reserve University	Cleveland	Ohio	United States	44106
8	Ohio State University Medical Center	Columbus	Ohio	United States	43210
9	University of Oklahoma	Oklahoma City	Oklahoma	United States	73104
10	University of Wisconsin-Madison	Madison	Wisconsin	United States	53792