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Status:

UNKNOWN

Donor Umbilical Cord Blood Transplant After Cyclophosphamide, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematologic Disease

Lead Sponsor:

Cancer Research UK

Conditions:

Hematopoietic/Lymphoid Cancer

Eligibility:

All Genders

2-60 years

Phase:

PHASE2

Brief Summary

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of abnormal cells. It also stops the patient's immune system...

Detailed Description

OBJECTIVES: * To assess the safety and efficacy of unrelated-donor umbilical cord blood transplantation (UCBT) using a nonmyeloablative preparative regimen in patients with hematological disease, in ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Diagnosis of high-risk, advanced or poorly responding hematological disease for which a reduced-intensity hemopoietic stem cell transplantation is likely to be effective
  • Disease status is such that there is no alternative therapy likely to achieve a cure or provide a significant prolongation of disease-free survival
  • No chronic myelogenous leukemia in first chronic phase responding to imatinib or refractory blast crisis
  • No acute leukemia in morphological relapse/persistent disease (defined as \> 5% blasts in normocellular bone marrow)
  • No malignant disease that is refractory to or progressive on salvage therapy
  • No myelofibrosis
  • Donor must be matched at HLA-A and -B at antigen level and HLA-DRB1 at allelic level
  • No available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor OR 10/10 unrelated volunteer donor
  • PATIENT CHARACTERISTICS:
  • Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100% (pediatrics)
  • Transaminases \< 5 times upper limit of normal (ULN)
  • Bilirubin \< 3 times ULN
  • Creatinine clearance \> 50 mL/min
  • DLCO \> 50% predicted
  • No supplemental oxygen requirements
  • Not pregnant or nursing
  • Negative pregnancy test
  • No HIV or HTLV (I and II) antibody positivity or evidence of infection
  • No acquired aplastic anemia
  • No decompensated congestive heart failure or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 35%
  • No current active serious infection, in particular uncontrolled fungal infection
  • No congenital immune deficiencies
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • More than 6 months since prior exposure to combination chemotherapy OR only 1 course of induction combination chemotherapy for myelodysplastic syndromes or acute myeloid leukemia (please discuss with study coordinator/s if this course contained fludarabine)
  • At least 6 months since prior myeloablative bone marrow transplantation
  • No prior irradiation that precludes the safe administration of an additional dose of 200 cGy of total-body irradiation
  • No prior autograft

Exclusion

    Key Trial Info

    Start Date :

    January 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT00959231

    Start Date

    January 1 2009

    Last Update

    August 26 2013

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Bristol Royal Hospital for Children

    Bristol, England, United Kingdom, BS2 8BJ

    2

    Cancer Research UK Clinical Centre at St. James's University Hospital

    Leeds, England, United Kingdom, LS16 6QB

    3

    University College of London Hospitals

    London, England, United Kingdom, NW1 2PQ

    4

    UCL Cancer Institute

    London, England, United Kingdom, WC1E 6DD