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

University of British Columbia

Status: Completed

Conditions: Hematological Malignancy; Bone Marrow Failure Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00897260

H08-02813

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

27 participants in 1 patient group

1

Experimental group

Treatment:

Procedure: 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

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