- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00103779
A Safety Study of SGN-40 in Patients With Non-Hodgkin's Lymphoma
17. december 2014 opdateret af: Seagen Inc.
A Phase I, Multi-Dose Study of SGN-40 (Anti-huCD40 mAb) in Patients With Non-Hodgkin's Lymphoma
This is an open-label, multi-dose, Phase I, dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell lymphomas.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A minimum of 3 patients will be entered into each dose-level cohort for 5 weeks.
A dose-escalation schema will be employed in cohorts.
The initial dose starts at 1 mg/kg on Day 1 and 4 followed by 2mg/kg on Day 8. Dose escalation will occur on weeks 3-5 with a maximum weekly dose of 8 mg/kg.
Patients who meet criteria of at least partial response will be eligible for additional 4 weekly doses at highest dose tolerated.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
50
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
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California
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Stanford, California, Forenede Stater, 94305
- Stanford University
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Florida
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Miami, Florida, Forenede Stater, 33136
- University of Miami
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New York
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New York, New York, Forenede Stater, 10029
- Cornell University
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Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
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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 a histological diagnosis of B cell non-Hodgkin's lymphoma, including diffuse large B-cell, mantle cell, follicular, small lymphocytic, and marginal zone lymphoma by the World Health Organization criteria.
- Patients must have an archived paraffin or fresh tumor specimen available for immunohistologic evaluation of CD40, CD20, & CD79a.
- Patients must have relapsed lymphoma and must have failed frontline chemotherapy.
- Patients who have not received autologous stem cell transplant must have refused or be ineligible for it.
- Patients must have completed radiotherapy, chemotherapy, and/or treatment with investigational anti-cancer agents 4 weeks prior to registration. Patients must have completed any monoclonal antibody treatment, including rituximab, 6 months prior to registration.
- Patients must have completed autologous bone marrow transplant 4 months prior to registration.
- Patient must have at least one site of measurable disease defined by unidimensional lesion ≥ 2 cm by conventional CT scan.
- Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.
Patients must have the following required baseline laboratory data:
- Platelet count ≥ 75,000/mm3,
- Hemoglobin ≥ 9.0 g/dL,
- Absolute neutrophil count ≥ 1,250/mm3,
- ALT/AST ≤ 2.5 times ULN,
- Total bilirubin ≤ 1.5 times ULN,
- Creatinine < 1.5 mg/dL,
- Females of childbearing potential must have a negative serum β-hCG pregnancy test result within 3 days prior to the first dose of SGN-40 and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug.
- If a deep venous thrombosis or other vascular even has required medical or surgical intervention in the past year, patients must either be on stable dose of anticoagulant therapy for at least 3 weeks or have completed anticoagulant therapy at least 3 months prior to registration with radiographic confirmation that thrombosis is resolved.
- Patients must be at least 18 years of age.
- Patients must be available for periodic blood sampling, study-related assessments and management of toxicity at the treating institution.
Exclusion Criteria:
- Patients with history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
- Patients with a documented history within 6 months of registration of a cerebral vascular event, myocardial infarction, deep venous thrombosis or other vascular event that has required medical or surgical intervention. Patients must have completed anticoagulant therapy at least 3 months prior to registration. Prophylactic anticoagulant therapy for indwelling catheters is acceptable.
- Patients who have received an allogeneic stem cell transplant.
- Patients who have had major surgery within 4 weeks prior to registration.
- Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
- Patients with a history of another primary malignancy that has not been in remission for at least 5 years (non-melanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear are exempt from the five year limit).
- Patients with any active systemic viral, bacterial, or fungal infection within four weeks prior to registration.
- Patients with known positivity for HIV, hepatitis B or hepatitis C infection.
- Patients with a history of significant chronic or recurrent infections requiring treatment.
- Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
- Patients on systemic steroids who have not been on a stable daily dose (not exceeding 10 mg prednisone or equivalent) during 4 weeks prior to the first dose of SGN 40.
- Patients who are pregnant or breastfeeding.
- Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment.
- Patients with dementia or altered mental status that would preclude the understanding and/or rendering of informed consent.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 1
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1 mg/kg IV (in the vein) on Day 1; 1-2 mg/kg IV on Day 4; 2-4 mg/kg IV on Day 8; 3-8 mg/kg on Days 15, 22 and 29.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
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Uønskede hændelser og abnormiteter i laboratoriet.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Studieleder: Jonathan Drachman, MD, Seagen Inc.
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.
Hjælpsomme links
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 2004
Primær færdiggørelse (Faktiske)
1. marts 2007
Studieafslutning (Faktiske)
1. marts 2007
Datoer for studieregistrering
Først indsendt
14. februar 2005
Først indsendt, der opfyldte QC-kriterier
14. februar 2005
Først opslået (Skøn)
15. februar 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
18. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SG040-0002
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 Non-Hodgkin lymfom
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Stanford UniversityNational Institutes of Health (NIH); AmgenAfsluttetLymfom, Non-Hodgkin | Lymfomer: Non-Hodgkin | Lymfomer: Non-Hodgkin perifer T-celle | Lymfomer: Non-Hodgkin kutan lymfom | Lymfomer: Non-Hodgkin diffuse store B-celler | Lymfomer: Non-Hodgkin follikulært / indolent B-celle | Lymfomer: Non-Hodgkin kappecelle | Lymfomer: Non-Hodgkin Marginal Zone | Lymfomer...Forenede Stater
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Marker Therapeutics, Inc.RekrutteringNon Hodgkin lymfom | Non-Hodgkin lymfom, voksen | Non-Hodgkin lymfom, refraktær | Non-Hodgkin lymfom, tilbagefaldForenede Stater
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Caribou Biosciences, Inc.RekrutteringLymfom | Lymfom, Non-Hodgkin | B-celle lymfom | Non Hodgkin lymfom | Refraktær B-celle non-Hodgkin lymfom | Recidiverende non-hodgkin lymfom | B-celle non-Hodgkins lymfomForenede Stater, Australien, Israel
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Mayo ClinicIkke rekrutterer endnuIndolent B-celle non-Hodgkin lymfom | Tilbagevendende indolent non-Hodgkin-lymfom | Refraktært indolent non-Hodgkin lymfom | Tilbagevendende indolent B-celle non-Hodgkin lymfom | Refraktært indolent B-celle non-Hodgkin lymfomForenede Stater
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)AfsluttetTilbagevendende Hodgkin-lymfom | Refraktært Hodgkin-lymfom | Refraktær B-celle non-Hodgkin lymfom | Refraktær T-celle non-Hodgkin lymfom | Tilbagevendende B-celle non-Hodgkin lymfom | Tilbagevendende T-celle non-Hodgkin lymfomForenede Stater
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Chongqing Precision Biotech Co., LtdRekrutteringNon Hodgkin lymfom | Refraktær non-Hodgkin lymfom | Recidiverende non-Hodgkin lymfomKina
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National Cancer Institute (NCI)RekrutteringRefraktær B-celle non-Hodgkin lymfom | Refraktær T-celle non-Hodgkin lymfom | Tilbagevendende B-celle non-Hodgkin lymfom | Tilbagevendende transformeret non-Hodgkin-lymfom | Tilbagevendende non-Hodgkin-lymfom | Refraktær non-Hodgkin lymfom | Tilbagevendende T-celle non-Hodgkin lymfom | Tilbagevendende... og andre forholdForenede Stater
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI)AfsluttetTilbagevendende Hodgkin-lymfom | Refraktært Hodgkin-lymfom | Tilbagevendende kappecellelymfom | Refraktær B-celle non-Hodgkin lymfom | Refraktær T-celle non-Hodgkin lymfom | Tilbagevendende B-celle non-Hodgkin lymfom | Tilbagevendende T-celle non-Hodgkin lymfom | Refractory Mantle Cell LymfomForenede Stater
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiv, ikke rekrutterendeRefraktært Hodgkin-lymfom | Refraktær B-celle non-Hodgkin lymfom | Refraktær T-celle non-Hodgkin lymfom | Modtager af hæmatopoietisk celletransplantationForenede Stater
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Acerta Pharma BVAstraZenecaAktiv, ikke rekrutterendeNon Hodgkin lymfomForenede Stater, Canada, Italien
Kliniske forsøg med SGN-40 (anti-huCD40 mAb)
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Seagen Inc.Genentech, Inc.AfsluttetLeukæmi, lymfatisk, kroniskForenede Stater
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Seagen Inc.Genentech, Inc.AfsluttetMyelomatoseForenede Stater
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Seagen Inc.AfsluttetAnaplastisk storcellet lymfomForenede Stater
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Genentech, Inc.Seagen Inc.Afsluttet
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Shanghai Junshi Bioscience Co., Ltd.Aktiv, ikke rekrutterendeNasopharyngealt karcinom | Gastrisk Adenocarcinom | Planocellulært karcinom i hoved og hals | Esophageal pladecellekarcinomKina
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Zhongnan HospitalRekrutteringHepatocellulært karcinom; Målrettet terapi; Progressionsfri overlevelseKina
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BiogenAfsluttetAkut optisk neuritisSverige, Australien, Italien, Spanien, Det Forenede Kongerige, Tyskland, Belgien, Danmark, Ungarn, Tjekkiet, Canada
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Genentech, Inc.Seagen Inc.Afsluttet
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Kyverna TherapeuticsIkke rekrutterer endnuMultipel sclerose | Multipel sklerose, sekundær progressiv | Multipel sklerose, primær progressiv
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GlaxoSmithKlineAfsluttet