Status:
COMPLETED
Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
Lead Sponsor:
University of British Columbia
Conditions:
Hematological Malignancy
Bone Marrow Failure Syndrome
Eligibility:
All Genders
Phase:
NA
Brief Summary
To determine the time to and rate of hematologic engraftment following unrelated umbilical cord blood transplantation in adults with one or two cord blood units using total body irradiation and fludar...
Eligibility Criteria
Inclusion
- Patients must have a histologically confirmed diagnosis at The Vancouver General Hospital or the BCCA-Vancouver.
- Eligible patients will have one of the following underlying diseases:
- High risk acute lymphoblastic leukemia (ALL) in first complete remission, with high risk being defined by the presence of t(4;11), t(9;22) or t(1;19) or patients presenting with extreme hyperleukocytosis (WBC \>100x109/L) or failure to achieve a complete remission after standard induction therapy.
- Acute myeloid leukemia (AML) in first complete remission with high risk cytogenetics or failure to achieve complete remission after standard induction therapy. ALL or AML in second or subsequent remission
- Myelofibrosis with myeloid metaplasia.
- Chronic myeloid leukemia in chronic (failed interferon and/or Gleevec) or accelerated phase.
- Myelodysplastic syndrome with IPSS risk category \>Int-1
- Aplastic anemia
- Non-Hodgkin's lymphoma, chronic lymphocytic leukemia or Hodgkin's disease in relapse or second or subsequent remission.
- Multiple Myeloma
- No active central nervous system (CNS) disease.
- No 9/10 or better HLA antigen matched related donor or VUD available.
- The patient's condition precludes waiting to search and find a VUD in the Unrelated Donor Registries
- Acceptance of standard blood product support
- Adequate organ function as defined by current Leukemia/BMT Program of BC standards (Appendix 10.1)
- Karnofsky performance status ≥ 80 (Appendix 10.2)
Exclusion
- Active infection
- Pregnancy
- Significant psychiatric disorder
- Progressive disease
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2013
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00897260
Start Date
May 1 2009
End Date
January 9 2013
Last Update
January 26 2018
Active Locations (1)
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1
Vancouver General Hospital, Leukemia/BMT Program of BC
Vancouver, British Columbia, Canada, V5Z 1M9