Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
NCT ID: NCT00897260
Last Updated: 2018-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2009-05-31
2013-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
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
* Fludarabine 40mg/m2 10:00am (After TBI) over 60 minutes x x x x Umbilical cord blood infusion (minimum of 24hrs after Flu infusion) x
* Fludarabine dose adjustment:
70ml/min: decrease dose by Creatinine Clearance 20% Fludarabine dosing will be based on the 40% adjusted ideal body weight.
UCB Infusion
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
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
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Interventions
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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
* Fludarabine 40mg/m2 10:00am (After TBI) over 60 minutes x x x x Umbilical cord blood infusion (minimum of 24hrs after Flu infusion) x
* Fludarabine dose adjustment:
70ml/min: decrease dose by Creatinine Clearance 20% Fludarabine dosing will be based on the 40% adjusted ideal body weight.
UCB Infusion
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
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
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Eligibility Criteria
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Inclusion Criteria
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
* Pregnancy
* Significant psychiatric disorder
* Progressive disease
ALL
No
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Donna E. Hogge
Principal Investigator
Principal Investigators
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Donna Hogge
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia - Vancouver Coastal Health Research Institute
Locations
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Vancouver General Hospital, Leukemia/BMT Program of BC
Vancouver, British Columbia, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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H08-02813
Identifier Type: -
Identifier Source: org_study_id
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