Donor Umbilical Cord Blood Transplant After Cyclophosphamide, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematologic Disease
NCT ID: NCT00959231
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2009-01-31
Brief Summary
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PURPOSE: This phase II trial is studying the side effects of donor umbilical cord blood transplant after cyclophosphamide, fludarabine phosphate, and total-body irradiation in treating patients with hematologic disease.
Detailed Description
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* 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 a multi-institution UK setting.
* To confirm that unrelated-donor UCBT following nonmyeloablative conditioning is associated with consistent and durable engraftment in these patients.
* To assess transplant-related mortality at day 100 associated with nonmyeloablative UCBT in these patients.
* To assess the incidence of grades II-IV and III-IV acute graft-vs-host disease (GVHD) in these patients.
* To assess the risk of relapse and progressive disease in these patients at 1 year post transplant after nonmyeloablative UCBT.
* To assess overall and progression-free survival of these patients at 1 year after nonmyeloablative UCBT.
* To assess immune reconstitution at 1, 2, 3, 6, 12, and 24 months after transplant as measured by quantitative recovery of B, T, and NK cells (flow cytometry), qualitative recovery of T cells (TREC and spectratyping), in vivo functional T-cell responses (EBV and CMV tetramers), and quantitative immunoglobulins.
OUTLINE: This is a multicenter study.
* Reduced-intensity conditioning regimen: Patients receive cyclophosphamide IV over 2 hours on day -6 and fludarabine phosphate IV over 1 hour on days -6 to -2. Patients undergo a single fraction of total-body irradiation on day -1.
* Umbilical cord blood (UCB) transplantation: Patients undergo umbilical cord blood transplantation on day 0.
* Graft-vs-host disease prophylaxis: Patients receive cyclosporine IV or orally on days -3 to 100 followed by taper and mycophenolate mofetil IV or orally on days -3 to 35 followed by taper.
Blood and bone marrow samples are collected periodically for analysis.
After completion of study treatment, patients are followed up every 3 months in year 1, every 4 months in year 2, every 6 months until 5 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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cyclophosphamide
cyclosporine
fludarabine phosphate
mycophenolate mofetil
laboratory biomarker analysis
nonmyeloablative allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
total-body irradiation
Eligibility Criteria
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Inclusion Criteria
* 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
2 Years
60 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
Principal Investigators
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Rachael Hough, MD
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
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Bristol Royal Hospital for Children
Bristol, England, United Kingdom
Cancer Research UK Clinical Centre at St. James's University Hospital
Leeds, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
UCL Cancer Institute
London, England, United Kingdom
Great Ormond Street Hospital for Children
London, England, United Kingdom
University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
Newcastle upon Tyne, England, United Kingdom
Countries
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Facility Contacts
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Contact Person
Role: primary
Contact Person
Role: primary
Rachael Hough, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
References
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Hough R, Lopes A, Patrick P, Russell N, Raj K, Tholouli E, A Snowden J, Collin M, El-Mehidi N, Lawrie A, Clifton-Hadley L, Veys P, Craddock C, Mackinnon S, Cook G, Shaw B, Marks D. Primary graft failure, but not relapse, may be identified by early chimerism following double cord blood unit transplantation. Blood Adv. 2022 Apr 12;6(7):2414-2426. doi: 10.1182/bloodadvances.2021005106.
Other Identifiers
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CRUK-UCL-RIC-UCBT
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2004-003845-41
Identifier Type: -
Identifier Source: secondary_id
EU-20946
Identifier Type: -
Identifier Source: secondary_id
CDR0000643641
Identifier Type: -
Identifier Source: org_study_id