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MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

23. april 2010 opdateret af: Bristol-Myers Squibb

An Open-label, Fixed-dose, Multicenter, Phase II Study of MDX-060 in Patients With Relapsed or Refractory Classic Systemic or Primary Cutaneous Anaplastic Large Cell Lymphoma

This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease. There will be 3 phases of this study: Induction, Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as other testing. Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression. The purpose of this study is to determine objective response rate at Day 50 in patients with relapsed or refractory classic systemic ALCL or primary cutaneous ALCL treated with MDX-060. Other objectives will be evaluated.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is an open-label, fixed-dose, multicenter study of MDX-060 in patients with ALCL who have relapsed or refractory disease. There will be 3 phases of this study: Induction, Maintenance, and Follow-up. Patients will be required to attend all protocol-required visits in the 4-week Induction Phase, in which administration of MDX-060 will occur, as well as other testing. Patients who complete the Induction Phase may be eligible for additional MDX-060 treatment ever 2 months for 1 year in the Maintenance Phase. Patients who complete the Maintenance Phase with a response of stable disease or better will be followed every 2 months for 1 year or until disease progression.

The primary objective of the study is to determine the objective response rate (ORR) at Day 50 in patients with relapsed or refractory classic systemic anaplastic large cell lymphoma (csALCL) or primary cutaneous ALCL (pcALCL) treated with MDX-060. The ORR will be based on an adaption of the NCI Response Criteria for Non-Hodgkin's Lymphoma (NHL) for patients with csALCL and will be based on the Physician's Global Assessment (PGA) for patient with pcALCL.

Secondary objectives include 1) characterizing progression-free survival (PFS); 2) determining response duration (RD); 3) characterizing the effect of MDX-060 on health-related Quality of Life (QoL); 4) evaluating patients with pcALCL using an adaption of the NCI Response Criteria for NHL; 5) characterizing the immunogenicity of MDX-060; 6) characterizing the safety of MDX-060; and 7) determining the best objective response rate (BORR) during the Maintenance Phase of the study.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

45

Fase

  • Fase 2

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
        • City of Hope, National Medical Center
      • Fresno, California, Forenede Stater, 93710
        • California Oncology of the Central Valley
      • La Jolla, California, Forenede Stater, 92093
        • Moores UCSD Cancer Center
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
    • New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08901
        • The Cancer Institute of New Jersey - Robert Wood Johnson Unv. Hosp.
    • New York
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Center
    • North Carolina
      • Huntersville, North Carolina, Forenede Stater, 28078
        • Carolina BioOncology Institute
  • Frankrig
      • Lille, Frankrig, 59037
        • Centre Hospitalier Regional Unv. de Lille, Hopital Claude Huriez

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

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • signed informed consent
  • confirmed diagnosis of ALCL
  • patient with csALCL must be confirmed CD30+
  • patients with csALCL must have failed or relapsed following second line (i.e. salvage) chemotherapy or relapsed or failed following autologous stem cell transplant.
  • patients with pcALCL must have progressed after treatment with local radiation therapy or surgical excision or failed systemic therapy with a single agent or multi-agent regimen.
  • patients with pcALCL must be confirmed CD30+
  • ECOG performance of 0 to 2
  • at least 12 years of age
  • life expectancy 12 weeks or greater
  • must meet screening laboratory values
  • women must be post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing a reliable form of contraception. All women must have a negative pregnancy test.
  • men must agree to the use of male contraception for the duration of the study
  • patients on corticosteroids must be tapered off the medication 2 weeks prior to the first MDX-060 administration and remain off corticosteroids until day 365.

Exclusion Criteria:

  • previous treatment with any anti-CD30 antibody
  • history of allogenic transplantation
  • any tumor lesion 10 cm or greater in diameter
  • any other malignancy, excluding basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Any cancer from which the patient has been disease free for at least 5 years is permissible.
  • any significant acter or chronic infection.
  • prior known serum positivity for HIV, hepatitis B or C as determined at screening.
  • treatment with an investigational agent within 30 days or 5 half-lives (whichever is longer) of study screening.
  • apparent active or latent tuberculosis infection (TB).
  • patients who are pregnant or nursing
  • any underlying medical condition which, in the investigator's opinion, will make the administration of MDX-060 hazardous or obscure the interpretation of adverse events.
  • concomitant chemotherapy, corticosteroids, investigational agents, other anti-ALCL biologics, or radiation therapy
  • patients with mycosis fungoides, or
  • patients with recurrent, self-healing papulonodular eruptions only or any other lymphoma other than ALCL.

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: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Livskvalitet
sikkerhed
Objektiv svarprocent
progressionsfri overlevelse
Immunogenicitet
svarvarighed
best objective response rate

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

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. februar 2006

Datoer for studieregistrering

Først indsendt

1. marts 2006

Først indsendt, der opfyldte QC-kriterier

1. marts 2006

Først opslået (Skøn)

2. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. april 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2010

Sidst verificeret

1. april 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MDX060-04

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 .

Kliniske forsøg med Lymfom, storcellet

Kliniske forsøg med MDX-060

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Uganda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner