ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00897260
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Donna E. Hogge, University of British Columbia

May 8, 2009
May 12, 2009
January 26, 2018
May 2009
January 9, 2013   (Final data collection date for primary outcome measure)
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy. [ Time Frame: 1 year ]
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
Complete list of historical versions of study NCT00897260 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis [ Time Frame: 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 ]
  • 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
Not Provided
Not Provided
 
Umbilical Cord Blood Transplantation As Treatment Of Adult Patients With Hematologic Disorders
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hematological Malignancy
  • Bone Marrow Failure Syndrome
  • 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
Experimental: 1
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
24
January 9, 2013
January 9, 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00897260
H08-02813
No
Not Provided
Not Provided
Donna E. Hogge, University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Donna Hogge University of British Columbia - Vancouver Coastal Health Research Institute
University of British Columbia
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP