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

23. august 2013 oppdatert av: Cancer Research UK

Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Haematological Diseases Using a Reduced Intensity Conditioning Regimen

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 from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening.

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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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 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.

Studietype

Intervensjonell

Registrering (Forventet)

60

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
    • England
      • Bristol, England, Storbritannia, BS2 8BJ
        • Rekruttering
        • Bristol Royal Hospital for Children
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-117-342-8044
      • Leeds, England, Storbritannia, LS16 6QB
        • Rekruttering
        • Cancer Research UK Clinical Centre at St. James's University Hospital
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-113-206-6020
      • London, England, Storbritannia, WC1N 3JH
        • Rekruttering
        • Great Ormond Street Hospital for Children
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-207-813-8335
      • London, England, Storbritannia, WC1E 6DD
        • Rekruttering
        • UCL Cancer Institute
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-207-830-2301
      • London, England, Storbritannia, NW1 2PQ
        • Rekruttering
        • University College of London Hospitals
        • Ta kontakt med:
          • Rachael Hough, MD
          • Telefonnummer: 44-845-155-5000 ext. 5239
      • Newcastle-Upon-Tyne, England, Storbritannia, NE2 4HH
        • Rekruttering
        • University of Newcastle-Upon-Tyne Northern Institute for Cancer Research
        • Ta kontakt med:
          • Contact Person
          • Telefonnummer: 44-191-222-7785

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

2 år til 60 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Non-relapse mortality at day 100

Sekundære resultatmål

Resultatmål
Incidence of grades II-IV and III-IV acute graft-vs-host disease (GVHD) at day 100 and chronic GVHD at 1 year
Mixed chimerism
Hemopoietic recovery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cancer Research UK

Etterforskere

  • Hovedetterforsker: Rachael Hough, MD, University College London Hospitals

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2009

Primær fullføring (Forventet)

1. august 2012

Datoer for studieregistrering

Først innsendt

13. august 2009

Først innsendt som oppfylte QC-kriteriene

13. august 2009

Først lagt ut (Anslag)

14. august 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

26. august 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. august 2013

Sist bekreftet

1. april 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000643641
  • CRUK-UCL-RIC-UCBT
  • EUDRACT-2004-003845-41
  • EU-20946

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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