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Ibrutinib and Lenalidomide With Dose Adjusted EPOCH-R in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma

14. januar 2019 opdateret af: Pharmacyclics LLC.

A Multicenter Study of Ibrutinib and Lenalidomide in Combination With DA-EPOCH-R in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma

This is a Phase 1b/2, open-label, non-randomized multicenter study to assess the safety and efficacy of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase 1b, open-label, non-randomized multicenter study conducted in 2 parts. Part 1, will determine the MTD of the combination of ibrutinib, lenalidomide and DA-EPOCH-R in subjects with DLBCL.

Ibrutinib will be administered at a fixed dose of 560 mg and lenalidomide will be dose-escalated. DA-EPOCH-R will be given at standard doses.

For Part 2, the MTD determined in Part 1 will be the dose used for all subjects. If no MTD is identified, then subjects in Part 2 will be treated with the maximum administered doses (MAD, treatment doses from dose Level 4).

The primary objective for Part 2 is to determine the ORR of ibrutinib and lenalidomide in combination with DA-EPOCH-R in subjects with ABC DLBCL as analyzed by gene expression profiling when treated at recommended phase 2 dose (RP2D).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

35

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Duarte, California, Forenede Stater, 91010
        • SITE-1
      • Los Angeles, California, Forenede Stater, 90095
        • SITE-2
      • Orange, California, Forenede Stater, 92868
        • SITE-10
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • SITE-3
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • SITE-5
      • Bethesda, Maryland, Forenede Stater, 20892
        • SITE-6
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • SITE-4
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87106
        • SITE-8
    • New York
      • Stony Brook, New York, Forenede Stater, 11794
        • SITE-9
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • SITE-7

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Major inclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Pathologically confirmed relapsed/refractory DLBCL
  • Subjects must have ≥1 measurable disease site on CT scan (≥ 1.5 cm in longest dimension).

  • Adequate hepatic and renal function:

    • AST or ALT ≤2.5 x ULN
    • Serum Creatinine ≤ 2.0 mg/dL and creatinine clearance ≥60 mL/min/1.73
    • Bilirubin ≤1.5 x ULN

  • Adequate hematologic function:

    • ANC >1,000 cells/mm3
    • Platelets ≥75,000 cells/mm3
    • Hemoglobin ≥8.0 g/dL
    • Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be ≤1.5 x the upper limit of the normal range (ULN)
  • Must be registered into the Revlimid REMS™program and be willing to comply with the requirements of Revlimid REMS™.

Major Exclusion Criteria:

  • Known central nervous system lymphoma
  • Any chemotherapy, external beam radiation therapy, or anti-cancer antibodies within 2 weeks
  • Radio- or toxin-immunoconjugates within 10 weeks
  • Prior allogenetic stem cell (or other organ) transplant within 6 months or any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to first dose of study drug

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Part 1: Dose Level 1
Ibrutinib 560 mg PO + DA-EPOCH-R
Medicin: Ibrutinib
Ibrutinib
Medicin: DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Eksperimentel: Part 1: Dose Level 2
Ibrutinib 560 mg (PO) +lenalidomide 15 mg (PO) + DA-EPOCH-R
Medicin: Ibrutinib
Ibrutinib
Medicin: DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Medicin: Lenalidomid
Lenalidomid
Eksperimentel: Part 1: Dose Level 3
Ibrutinib 560 mg (PO) +lenalidomide 20 mg (PO) + DA-EPOCH-R
Medicin: Ibrutinib
Ibrutinib
Medicin: DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Medicin: Lenalidomid
Lenalidomid
Eksperimentel: Part 1: Dose Level 4
Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
Medicin: Ibrutinib
Ibrutinib
Medicin: DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Medicin: Lenalidomid
Lenalidomid
Eksperimentel: Part 2: RP2D
Recommended Phase 2 Dose(RP2D): Ibrutinib 560 mg (PO) +lenalidomide 25 mg (PO) + DA-EPOCH-R
Medicin: Ibrutinib
Ibrutinib
Medicin: DA-EPOCH-R
Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
Medicin: Lenalidomid
Lenalidomid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Dose-Limiting Toxicities as a Measure of Safety and Tolerability
Tidsramme: 1 year after last subjects received the first dose
Part-1: To determine the maximum tolerated dose (MTD) of the combination of ibrutinib and lenalidomide with dose adjusted EPOCH-R
1 year after last subjects received the first dose
Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy-ORR
Tidsramme: 1 year after last subjects received the first dose
Part 2 - Overall Response rate will be defined as the proportion of subjects who achieve either a Complete Response or a Partial Response according to the international Working Group Response Criteria for NHL as assessed by investigator.
1 year after last subjects received the first dose

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Complete Responses (CR) and Partial Responses (PR) as a Measure of Efficacy
Tidsramme: 1 year after last subjects received the first dose
Part-1: Overall Response rate (ORR) will defined as the proportion of subjects who achieve either a CR or a PR according to the international Working Group Response Criteria for NHL as assessed by investigator.
1 year after last subjects received the first dose
Number of Subjects With Adverse Events as a Measure of Safety and Tolerability
Tidsramme: 1 year after last subjects received the first dose
Part 2: The frequency (number and percentage) of treatment-emergent adverse events will be reported.
1 year after last subjects received the first dose
Progression Free Survival (PFS) and Overall Survival (OS) as a Measure of Efficacy
Tidsramme: From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most.
Part 2: PFS will be measured as time from first study drug administration to disease progression or death from any cause. OS will be measured from the time of first study drug administration until the date of death using Kaplan-Meier methodology.
From initial dose date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose, up to 36 months at the most.
Duration of Response (DOR)
Tidsramme: From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose.
Part 2: DOR will be measured from the time by which the measurement criteria are met for CR or PR until the first date by which recurrent or progressive disease is objectively documented.
From initial response date until the date of first documented progression or death from any cause, whichever came first, assessed up to approximately 1 year after the last subject received the first dose.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pharmacyclics LLC.

Samarbejdspartnere

Celgene Corporation

Efterforskere

  • Studieleder: Jutta Neuenburg, MD, Pharmacyclics LLC (An AbbVie Company)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2014

Primær færdiggørelse (Faktiske)

1. august 2017

Studieafslutning (Faktiske)

1. august 2017

Datoer for studieregistrering

Først indsendt

12. maj 2014

Først indsendt, der opfyldte QC-kriterier

19. maj 2014

Først opslået (Skøn)

20. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. januar 2019

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PCYC-1124-CA

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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