Adult Double Cord Blood Transplant Study

Completed · Phase 2

Conditions studied: Cord Blood Stem Cell Transplantation, Hematologic Malignancies

In brief

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%.

Key facts

Study ID

NCT00514579

Run by

Center for International Blood and Marrow Transplant Research

People needed

56

Starts

2007-08-01

Expected to finish

2013-08-01

Last updated by the study team

2014-03-10

Who can join

Age: 22 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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