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Phase I/II Study of CAMPATH in Patients With Relapsing or Refractory Non-Hodgkin's Lymphoma

4. marts 2015 opdateret af: Genzyme, a Sanofi Company
The purpose of this study is to determine the optimal dose of Campath for patients with relapsing or refractory (failed standard therapy) non-Hodgkin's lymphoma. The study will also evaluate the safety of the drug and whether it is effective in treating these patients.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study is being conducted in 2 parts with the primary objective of part 1 being to determine the maximum tolerated dose (MTD) of CAMPATH (alemtuzumab, MABCAMPATH, CAMPATH) administered intravenously (IV) once a week as treatment for relapsing or refractory non-Hodgkin's lymphoma (NHL). The primary objective of part 2 is to determine the overall response rate (complete response, CR/unconfirmed , plus partial response) of weekly IV CAMPATH in the treatment of relapsing or refractory NHL. This is a Phase I/II study, open-label, multicenter study to evaluate the efficacy and safety of weekly IV CAMPATH as therapy for patients with relapsing or refractory non-Hodgkin's lymphoma.

Undersøgelsestype

Interventionel

Tilmelding

61

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
    • Colorado
      • Aurora, Colorado, Forenede Stater
      • Colorado Springs, Colorado, Forenede Stater
      • Denver, Colorado, Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater
    • Kansas
      • Overland Park, Kansas, Forenede Stater
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater
    • Missouri
      • Kansas City, Missouri, Forenede Stater
    • New Mexico
      • Santa Fe, New Mexico, Forenede Stater
    • Ohio
      • Dayton, Ohio, Forenede Stater
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater
    • Texas
      • Dallas, Texas, Forenede Stater
      • Ft. Worth, Texas, Forenede Stater
      • Plano, Texas, Forenede Stater
      • San Antonio, Texas, Forenede Stater
      • Tyler, Texas, Forenede Stater
    • Washington
      • Spokane, Washington, Forenede Stater
      • Vancouver, Washington, Forenede Stater

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

Inclusion Criteria: Patients must have:

  • Pathologically confirmed diagnosis of relapsing or refractory non-Hodgkin's lymphoma that has failed conventional therapy.
  • Measurable disease (lesions that can be accurately measured by CT scan and a greatest transverse diameter larger or equal to 1 cm or palpable lesions that both diameters larger or equal to 2 cm).
  • Life expectancy of at least 12 weeks. - World Health Organization (WHO) performance status (PS) of 0, 1, or 2.
  • Adequate marrow and organ function (details are listed in the protocol).
  • Female patients with childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. Male and female patients must agree to use an effective contraceptive method while on study treatment, if appropriate, and for a minimum of 6 months following study therapy.
  • Signed, written informed consent.

Exclusion Criteria: Patients must not have:

  • Prior autologous bone marrow or stem cell transplant within 6 months of study entry.
  • A history of prior allogeneic bone marrow transplant or organ transplant.
  • Previously untreated non-Hodgkin's lymphoma.
  • Previously treated with CAMPATH.
  • Patients with bulky disease, ie any single mass > 7.5cm.
  • Prior radiotherapy to the only site of measurable disease.
  • Medical condition requiring chronic use of oral, high-dose corticosteroids.
  • Autoimmune thrombocytopenia.
  • Use of investigational agents within previous 30 days or any anti-cancer therapy within the previous 3 weeks. Patients must have recovered from all acute toxicities of any prior therapy.
  • Past history of anaphylaxis following exposure to humanized monoclonal antibodies.
  • Active, uncontrolled infection, including human immunodeficiency virus (HIV) positive.
  • Active secondary malignancy.
  • Active central nervous system (CNS) involvement with NHL.
  • Pregnant or lactating women. Male or female patients who do not agree to use effective contraceptive method(s) during the study.
  • Any significant concurrent disease or illness that would, in the opinion of the investigator, compromise patient safety or compliance, or interfere with the interpretation of study results.

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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Samarbejdspartnere og efterforskere

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

Sponsor

Genzyme, a Sanofi Company

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. december 2002

Studieafslutning (Faktiske)

1. august 2005

Datoer for studieregistrering

Først indsendt

15. januar 2003

Først indsendt, der opfyldte QC-kriterier

16. januar 2003

Først opslået (Skøn)

17. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. marts 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2015

Sidst verificeret

1. marts 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CAM.NHL232
  • BLA 99-0786

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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