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Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)

17. juli 2014 oppdatert av: Pharmacyclics LLC.

A Phase 1b, Multicenter, Open-label, Parallel-group Safety Study of a Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI 32765, in Combination With Chemotherapy in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI 32765 420 mg once daily oral (PO) administration in combination with 2 different chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Studietype

Intervensjonell

Registrering (Faktiske)

33

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Dana Farber Cancer Center
    • New York
      • New Hyde Park, New York, Forente stater, 11042
        • CLL Research and Treatment Program
      • New York, New York, Forente stater, 10065
        • Weill Medical College of Cornell University
      • Rochester, New York, Forente stater, 14642
        • University of Rochester
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, Forente stater, 77030
        • MD Anderson

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment:

    • Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
    • Anemia (<11 g/dL) or thrombocytopenia (<100,000/μL) due to bone marrow involvement
    • Presence of unintentional weight loss > 10% over the preceding 6 months
    • NCI CTCAE Grade 2 or 3 fatigue
    • Fevers > 100.5° or night sweats for > 2 weeks without evidence of infection
    • Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of < 6 months
  2. 1 to 3 prior treatment regimens for CLL/SLL
  3. ECOG performance status of ≤ 1
  4. ≥ 18 years of age
  5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
  6. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations)

Exclusion Criteria:

  1. Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug
  2. Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug
  3. Concomitant use of medicines known to cause QT prolongation or torsades de pointes
  4. Transformed lymphoma or Richter's transformation Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
  5. Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) < 1000 cells/mm3 (1.0 x 109/L) oPlatelet count < 50,000/mm3 (50 x 109/L) oSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) oCreatinine > 2.0 x ULN or creatinine clearance < 40 mL/min

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
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR)
Legemiddel: PCI-32765
420 mg daily
Eksperimentell: PCI-32765 plus bendamustine/rituximab (BR)
Legemiddel: PCI-32765
420 mg daily

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of Prolonged Hematologic Toxicity Started in Cycle 1
Tidsramme: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib
Tidsramme: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0
Tidsramme: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
Overall Incidence of Serious Adverse Events (SAEs)
Tidsramme: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])
Tidsramme: From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.
Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.
From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.
Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline
Tidsramme: From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.
From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.
Progression Free Survival Rate at 12 Months
Tidsramme: From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.
Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.
From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.

Samarbeidspartnere og etterforskere

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

Sponsor

Pharmacyclics LLC.

Etterforskere

  • Studieleder: Thorsten Graef, MD, Pharmacyclics LLC.

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

Hjelpsomme linker

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. februar 2011

Primær fullføring (Faktiske)

1. november 2012

Studiet fullført (Faktiske)

1. mai 2013

Datoer for studieregistrering

Først innsendt

2. februar 2011

Først innsendt som oppfylte QC-kriteriene

8. februar 2011

Først lagt ut (Anslag)

9. februar 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

24. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. juli 2014

Sist bekreftet

1. juli 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PCYC-1108-CA
  • PCI-32765 (Annen identifikator: Pharmacyclics)

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