Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
Primary Purpose
Hematological Malignancy, Bone Marrow Failure Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Sponsored by
About this trial
This is an interventional treatment trial for Hematological Malignancy focused on measuring Unrelated Umbilical Cord Blood Transplant, Multiple cord blood
Eligibility 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
Sites / Locations
- Vancouver General Hospital, Leukemia/BMT Program of BC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
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.
To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.
To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis
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
Full Information
NCT ID
NCT00897260
First Posted
May 8, 2009
Last Updated
January 24, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00897260
Brief Title
Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
Official Title
Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 9, 2013 (Actual)
Study Completion Date
January 9, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 fludarabine as the transplant conditioning regimen and cyclosporine/MMF as graft-versus-host disease prophylaxis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematological Malignancy, Bone Marrow Failure Syndrome
Keywords
Unrelated Umbilical Cord Blood Transplant, Multiple cord blood
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Intervention Description
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
Intervention Type
Radiation
Intervention Name(s)
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders
Primary Outcome Measure Information:
Title
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
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
Title
To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis
Time Frame
1 year
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Hogge
Organizational Affiliation
University of British Columbia - Vancouver Coastal Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital, Leukemia/BMT Program of BC
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.leukemiabmtprogram.com/
Description
Related Info
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Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
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