Adult Double Cord Blood Transplant Study

Hematologic Malignancies Clinical Trial

Official title:

A Phase II Multicenter Trial of Myeloablative Double Unit Umbilical Cord Blood Transplantation (UCBT) in Adults With Hematologic Malignancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514579
• Other study ID #: 05-DCB
• Status: Completed
• Phase: Phase 2
• First received: August 8, 2007
• Last updated: March 7, 2014
• Start date: August 2007
• Est. completion date: August 2013

Study information

• Verified date: March 2014
• Source: Center for International Blood and Marrow Transplant Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 50 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cord Blood Stem Cell Transplantation
• Hematologic Malignancies
• Neoplasms

Intervention

Procedure:
• Cord blood transplantation
Myeloablative preparative regimen of chemotherapy and radiation followed by double unit umbilical cord blood transplantation

Locations

Country	Name	City	State
United States	Blood and Marrow Transplant Program at Northside Hospital	Atlanta	Georgia
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	City of Hope	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	University of California at Los Angeles	Los Angeles	California
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Center for International Blood and Marrow Transplant Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure overall survival of double unit UCBT in adult patients with hematologic malignancies		One year	Yes
Secondary	Measure incidence of donor-derived neutrophil and platelet recovery		100 Days	Yes
Secondary	Measure contribution of each unit to initial and sustained engraftment		2 years	No
Secondary	Measure incidence and severity of acute graft-versus-host disease		100 Days	Yes
Secondary	Measure incidence and severity of chronic GVHD		1 year	Yes
Secondary	Measure incidence of transplant-related mortality		6 months	Yes
Secondary	Measure incidence of malignant relapse		2 years	Yes
Secondary	Measure incidence of serious infectious complications		1 year	Yes
Secondary	Measure incidence of immune reconstitution		2 years	No
Secondary	Measure probability of overall and disease-free survival		2 years	Yes