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

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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

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.

Condition or disease Intervention/treatment
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  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Umbilical Cord Blood Transplantation as Treatment of Adult Patients With Hematologic Disorders
Study Start Date : May 2009
Primary Completion Date : January 9, 2013
Study Completion Date : January 9, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Disorders
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis [ Time Frame: 1 year ]
  4. 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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897260


Locations
Canada, British Columbia
Vancouver General Hospital, Leukemia/BMT Program of BC
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Donna Hogge University of British Columbia - Vancouver Coastal Health Research Institute

Additional Information:
Responsible Party: Donna E. Hogge, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT00897260     History of Changes
Other Study ID Numbers: H08-02813
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by Donna E. Hogge, University of British Columbia:
Unrelated Umbilical Cord Blood Transplant
Multiple cord blood

Additional relevant MeSH terms:
Pancytopenia
Hematologic Diseases
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Anemia
Bone Marrow Diseases
Anemia, Hemolytic
Myelodysplastic Syndromes