Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders - Full Text View

Sponsor:	University of British Columbia
Information provided by (Responsible Party):	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00897260

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:

Genetics Home Reference related topics: paroxysmal nocturnal hemoglobinuria

MedlinePlus related topics: Cancer

U.S. FDA Resources

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 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 Radiation: 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 Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders

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

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

Radiation: 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

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:

Related Info This link exits the ClinicalTrials.gov site

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 February 09, 2012