Status:
COMPLETED
Trial Of Double Umbilical Cord Blood Transplantation
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Hematological Malignancies
Eligibility:
All Genders
Up to 65 years
Phase:
PHASE2
Brief Summary
This pilot research study is to investigate the safety and effectiveness of stem cell transplantation to treat blood-related (hematopoietic) cancers, using stem cells collected from two different, umb...
Eligibility Criteria
Inclusion
- The candidate must have an incurable hematological malignancy or non-malignant hematological disorder and be eligible for transplant by the University of Michigan program.
- The candidate must have a life expectancy of less than one year without transplantation.
- The candidate must have two partially HLA-matched UCB (cord blood) units.Units must be HLA-matched minimally at 4 of 6 HLA-A and B (at intermediate resolution by molecular typing) and DRB1 (at high resolution by molecular typing) loci. Units must be HLA-matched at 3 of 6 HLA- A, B, DRB1 loci with each other (using same resolution of molecular typing as indicated above).
- The candidate must have access to two appropriately HLA-matched units that are available such that one unit delivers a pre-cryopreserved nucleated cell dose of at least 2.5 x 107 per kilogram and the second unit at least 2.0 x 107 per kilogram.
Exclusion
- The candidate is an adult or pediatric patient who has a suitable related or unrelated donor available for transplant. Suitable donors include 8/8 (HLA-A,B,C and DR, with all loci high-resolution typing) or 7/8 related or unrelated donor available within 42 days of search initiation.
- The candidate has a Karnofsky (Adult) or Lansky (Pediatrics) performance status of \< 70% at the time of admission for HSCT.
- The candidate is a patient with evidence of HIV infection.
- The candidate is a patient with active bacterial, fungal or viral infection not responding to treatment. Non-response to treatment is determined by body temperature, blood culture results, and radiographic findings as applicable.
- The candidate is pregnant.
- The candidate has any medical comorbidities/conditions that, in the opinion of the transplant team, would keep the patient from complying with the needs of the protocol and/or would markedly increase the morbidity and mortality from the procedure.
- The candidate has any conditions, in the opinion of the transplant team, such as substance abuse, or severe personality disorder that would keep the patient from complying with the needs of the protocol and would markedly increase the morbidity and mortality from the procedure.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00763490
Start Date
December 1 2008
End Date
October 1 2015
Last Update
December 23 2016
Active Locations (1)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109