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Completed

NCT Number: NCT00897260

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver General Hospital, Leukemia/BMT Program of BC

Vancouver, British Columbia, V5Z 1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

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

Radiation

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

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

Procedure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 100 days

  2. To determine the incidence of grades II-IV and grades III-IV acute GVHD and incidence of limited and extensive chronic GVHD.

    Time frame: 1 year

  3. To measure time to immunologic reconstitution as defined by normal numbers of T and B-cells and normal immunoglobulin synthesis

    Time frame: 1 year

  4. 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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 12, 2009
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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