- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00897260
Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders
Study Overview
Status
Intervention / Treatment
- 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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital, Leukemia/BMT Program of BC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 100 days
|
100 days
|
To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.
Time Frame: 1 year
|
1 year
|
To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis
Time Frame: 1 year
|
1 year
|
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
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Donna Hogge, University of British Columbia - Vancouver Coastal Health Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H08-02813
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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