Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
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
  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

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014