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

Not Applicable

Completed

• Conditions: Hematological Malignancy; Bone Marrow Failure Syndrome
• Interventions: Procedure: Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders

• Registration Number: NCT00897260
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-08
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Primary Completion: 2013-01-09
• Study Completion: 2013-01-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Umbilical Cord Blood Transplantation as Treatment of Adult Patients with Hematologic Disorders	-

Primary Outcome Measures

Name	Time	Method
To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.	1 year

Secondary Outcome Measures

Name	Time	Method
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.	100 days
To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.	1 year
To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis	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	1 year

Trial Locations

Locations (1)

Vancouver General Hospital, Leukemia/BMT Program of BC; 🇨🇦 Vancouver, British Columbia, Canada