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

Hematological Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897260
• Other study ID #: H08-02813
• Status: Completed
• Phase: N/A
• First received: May 8, 2009
• Last updated: January 24, 2018
• Start date: May 2009
• Est. completion date: January 9, 2013

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 9, 2013
• Est. primary completion date: January 9, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Aplastic
• Bone Marrow Failure Syndrome
• Hematologic Diseases
• Hematological Malignancy
• Hemoglobinuria, Paroxysmal
• Pancytopenia

Intervention

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

Locations

Country	Name	City	State
Canada	Vancouver General Hospital, Leukemia/BMT Program of BC	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and efficacy of multiple cord blood transplantation in patients with hematological malignancy.		1 year
Secondary	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
Secondary	To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.		1 year
Secondary	To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis		1 year
Secondary	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

External Links

•   Link