Trial record 8 of 431 for:
"cord blood"
Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
This study is currently recruiting participants.
Verified November 2011 by University of British Columbia
Sponsor:
University of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00897260
First received: May 8, 2009
Last updated: November 21, 2011
Last verified: November 2011
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Purpose
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 fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis.
| Condition | Intervention |
|---|---|
|
Hematological Malignancy Bone Marrow Failure Syndrome |
Drug: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders Radiation: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy. [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To determine the 100-day treatment related mortality (TRM), complete remission rate and the 2-year progression free and overall survival rate for patients under going this treatment. [ Designated as safety issue: No ]
- To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD. [ Designated as safety issue: No ]
- To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis [ Designated as safety issue: No ]
- To determine rate of hematologic engraftment following umbilical cord blood transplantation with 1-2 cord blood units using total body irradiation & fludarabine as transplant conditioning regimen & cyclosporine/MMF as graft-vs-host disease prophylaxis [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
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 fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis. DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x
UCB Infusion DRUG/DOSE DAYS -9 -8, -7 -6 -5 -4 -3 -2 -1 Total Body Irradiation 150 cGy per treatment (1350cGy total) 2x 2x 2x 2x 1x
Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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 Criteria:
- Active infection
- Pregnancy
- Significant psychiatric disorder
- Progressive disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897260
Contacts
| Contact: Donna Hogge | 604-875-4863 | dhogge@bccancer.bc.ca |
Locations
| Canada, British Columbia | |
| Vancouver General Hospital, Leukemia/BMT Program of BC | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Donna Hogge, MD, PhD 604-875-4863 | |
Sponsors and Collaborators
University of British Columbia
Investigators
| Principal Investigator: | Donna Hogge | University of British Columbia - Vancouver Coastal Health Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00897260 History of Changes |
| Other Study ID Numbers: | H08-02813 |
| Study First Received: | May 8, 2009 |
| Last Updated: | November 21, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Unrelated Umbilical Cord Blood Transplant Multiple cord blood |
Additional relevant MeSH terms:
|
Neoplasms Hematologic Diseases Pancytopenia Hematologic Neoplasms Hemoglobinuria, Paroxysmal |
Neoplasms by Site Anemia, Hemolytic Anemia Myelodysplastic Syndromes Bone Marrow Diseases |
ClinicalTrials.gov processed this record on May 16, 2013