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Adult Double Cord Blood Transplant Study | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00514579•Center for International Blood and Marrow Transplant Research

View on ClinicalTrials.gov

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%.

Eligibility

Age

22 - 50 years

Sex

ALL

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
+5 more criteria

Locations (10)

City of Hope

Duarte, California, United States

University of California at Los Angeles

Los Angeles, California, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Blood and Marrow Transplant Program at Northside Hospital

Atlanta, Georgia, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

University of Wisconsin-Madison

Madison, Wisconsin, United States

Key Dates

Start Date

August 1, 2007

Primary Completion Date

August 1, 2013

Completion Date

August 1, 2013

Last Updated

March 10, 2014

Enrollment

ACTUAL participants

Conditions

Cord Blood Stem Cell TransplantationHematologic Malignancies

Interventions

Cord blood transplantation

PROCEDURE

Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies

NCT05011422

Pediatric Hematologic Malignancies

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RECRUITINGNA

Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies

NCT07285668

Hematologic Malignancies

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RECRUITINGPHASE1

A Phase 1 Study of IM-1021 in Participants With Advanced Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Adult Double Cord Blood Transplant Study

Inclusion Criteria

Exclusion Criteria

Haploidentical Hematopoietic Stem Cell Transplantation With Ex Vivo TCR Alpha/Beta and CD19 Depletion in Pediatric Hematologic Malignancies

Prophylactic TCRaB+ and CD19+ Depleted Donor Lymphocyte Infusion After Allogeneic Stem Cell Transplant in High-Risk Patients With Hematologic Malignancies

A Phase 1 Study of IM-1021 in Participants With Advanced Cancer

A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies

Liposomal Amphotericin B Plus Posaconazole/Isavuconazole for Mucormycosis in Hematologic Malignancies: Efficacy and Safety

A Clinical Trial Evaluating TQB2101 in Subjects With Advanced Hematologic Malignancies