Clinical trial NCT00897260: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematological Malignancy
Bone Marrow Failure Syndrome
Keywords: Unrelated Umbilical Cord Blood Transplant
Multiple cord blood
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 100 days
measure: To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.
timeFrame: 1 year
measure: To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis
timeFrame: 1 year
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital, Leukemia/BMT Program of BC
state: British Columbia
Study officials:
affiliation: University of British Columbia - Vancouver Coastal Health Research Institute
name: Donna Hogge
role: PRINCIPAL_INVESTIGATOR
References: