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

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

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.
    



Study Type

Interventional


Primary Outcome

To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.

Secondary Outcome

 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.

Condition

Hematological Malignancy

Intervention

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

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

27

Start Date

May 2009

Completion Date

January 9, 2013

Primary Completion Date

January 9, 2013

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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Donna Hogge, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00897260

Organization ID

H08-02813


Responsible Party

Principal Investigator

Study Sponsor

University of British Columbia


Study Sponsor

Donna Hogge, Principal Investigator, University of British Columbia - Vancouver Coastal Health Research Institute


Verification Date

January 2018