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Rituximab and Galiximab in Treating Patients With Stage II, Stage III, or Stage IV Non-Hodgkin's Lymphoma

1. juli 2016 oppdatert av: Alliance for Clinical Trials in Oncology

A Phase II Trial of Extended Induction Galiximab (Anti-CD80 Monoclonal Antibody) (IND #12373) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin Lymphoma (NHL)

RATIONALE: Monoclonal antibodies, such as rituximab and galiximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one monoclonal antibody may be a better way to block cancer growth.

PURPOSE: This phase II trial is studying how well giving rituximab together with galiximab works in treating patients with stage II, stage III, or stage IV non-Hodgkin's lymphoma.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

OBJECTIVES:

Primary

  • Determine the overall and complete response rate in patients with previously untreated CD20-positive bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma treated with rituximab and galiximab.
  • Determine the time to disease progression in patients treated with this regimen.

Secondary

  • Determine the toxicity profile of this regimen in these patients.
  • Correlate Fc receptor polymorphism profiling with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • Induction therapy (month 1): Patients receive rituximab IV on days 1, 8, 15, and 22 and galiximab IV over 1 hour on day 3, 8, 15, and 22.
  • Extended induction therapy (months 3, 5, 7, and 9): Beginning in month 3, patients receive rituximab and galiximab as above on day 1. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 4 months for up to 10 years.

PROJECTED ACCRUAL: A total of 51 patients will be accrued for this study within 18 months.

Studietype

Intervensjonell

Registrering (Faktiske)

62

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Fort Lauderdale, Florida, Forente stater, 33308
        • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Hollywood, Florida, Forente stater, 33021
        • Memorial Cancer Institute at Memorial Regional Hospital
      • Jupiter, Florida, Forente stater, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, Forente stater, 33140
        • CCOP - Mount Sinai Medical Center
    • Illinois
      • Canton, Illinois, Forente stater, 61520
        • Graham Hospital
      • Carthage, Illinois, Forente stater, 62321
        • Memorial Hospital
      • Chicago, Illinois, Forente stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Eureka, Illinois, Forente stater, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Forente stater, 61401
        • Galesburg Cottage Hospital
      • Galesburg, Illinois, Forente stater, 61401
        • Galesburg Clinic
      • Havana, Illinois, Forente stater, 62644
        • Mason District Hospital
      • Hopedale, Illinois, Forente stater, 61747
        • Hopedale Medical Complex
      • Kewanee, Illinois, Forente stater, 61443
        • Kewanee Hospital
      • Macomb, Illinois, Forente stater, 61455
        • Mcdonough District Hospital
      • Normal, Illinois, Forente stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forente stater, 61761
        • Community Cancer Center
      • Ottawa, Illinois, Forente stater, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Forente stater, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, Forente stater, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Forente stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forente stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forente stater, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Forente stater, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, Forente stater, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Forente stater, 61356
        • Perry Memorial Hospital
      • Spring Valley, Illinois, Forente stater, 61362
        • St. Margaret's Hospital
    • Indiana
      • Fort Wayne, Indiana, Forente stater, 46815
        • Fort Wayne Medical Oncology and Hematology
    • Iowa
      • Cedar Rapids, Iowa, Forente stater, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, Forente stater, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
      • Cedar Rapids, Iowa, Forente stater, 52402
        • Iowa Blood and Cancer Care
      • Iowa City, Iowa, Forente stater, 52242
        • Holden Comprehensive Cancer Center at University of Iowa
    • Maine
      • Bangor, Maine, Forente stater, 04401
        • CancerCare of Maine at Eastern Maine Medial Center
    • Massachusetts
      • Worcester, Massachusetts, Forente stater, 01655
        • UMASS Memorial Cancer Center - University Campus
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55417
        • Veterans Affairs Medical Center - Minneapolis
    • Missouri
      • Columbia, Missouri, Forente stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Jefferson City, Missouri, Forente stater, 65101
        • Capital Region Cancer Center
      • St Louis, Missouri, Forente stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital
      • St. Louis, Missouri, Forente stater, 63131
        • Missouri Baptist Cancer Center
    • New Hampshire
      • Hooksett, New Hampshire, Forente stater, 03106
        • New Hampshire Oncology-Hematology, PA - Hooksett
      • Keene, New Hampshire, Forente stater, 03431
        • Kingsbury Center for Cancer Care at Cheshire Medical Center
      • Lebanon, New Hampshire, Forente stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, Forente stater, 03103
        • Elliot Regional Cancer Center
      • Rochester, New Hampshire, Forente stater, 03867
        • Frisbie Memorial Hospital
    • New York
      • Buffalo, New York, Forente stater, 14263-0001
        • Roswell Park Cancer Institute
      • Glens Falls, New York, Forente stater, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • New Hyde Park, New York, Forente stater, 11042
        • Long Island Jewish Medical Center
      • New York, New York, Forente stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forente stater, 10021
        • New York Weill Cornell Cancer Center at Cornell University
      • Syracuse, New York, Forente stater, 13215
        • Community General Hospital of Greater Syracuse
      • Syracuse, New York, Forente stater, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Gastonia, North Carolina, Forente stater, 28053
        • CaroMont Cancer Center at Gaston Memorial Hospital
      • Goldsboro, North Carolina, Forente stater, 27534
        • Wayne Radiation Oncology
      • Goldsboro, North Carolina, Forente stater, 27534
        • Wayne Memorial Hospital, Incorporated
      • Hendersonville, North Carolina, Forente stater, 28791
        • Pardee Memorial Hospital
      • Kinston, North Carolina, Forente stater, 28501
        • Lenoir Memorial Cancer Center
      • Wilson, North Carolina, Forente stater, 27893-3428
        • Wilson Medical Center
      • Winston-Salem, North Carolina, Forente stater, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, Forente stater, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15224-1791
        • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
    • South Carolina
      • Florence, South Carolina, Forente stater, 29501
        • McLeod Regional Medical Center
      • Greenville, South Carolina, Forente stater, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, Forente stater, 29601
        • Bon Secours St. Francis Health System
    • Vermont
      • Berlin, Vermont, Forente stater, 05602
        • Mountainview Medical
      • Burlington, Vermont, Forente stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Danville, Virginia, Forente stater, 24541
        • Danville Regional Medical Center
      • Martinsville, Virginia, Forente stater, 24115
        • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
    • West Virginia
      • Huntington, West Virginia, Forente stater, 25702
        • St. Mary's Regional Cancer Center at St. Mary's Medical Center

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

  1. Documentation of Disease

    1.1 Previously untreated, histologically confirmed follicular lymphoma, WHO classification, grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) which is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II.

    1.1.1 Bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies. Fine needle aspirates are not acceptable.

    1.1.2 Failure to submit pathology specimens within 60 days of patient registration will result in the patient being declared ineligible.

    1.2 Institutional flow cytometry or immunohistochemistry must confirm CD20 antigen expression.

    1.3 Patients classified as high risk according to the Follicular Lymphoma International Prognostic Index (FLIPI) should be considered for CALGB 50102/SWOG S0016 (A Phase III Trial of CHOP vs CHOP + Rituximab vs CHOP + Iodine-131-Labeled Monoclonal Anti-B1 Antibody [Tositumomab] For Treatment of Newly Diagnosed Follicular Non-Hodgkin's Lymphomas).

  2. Prior Treatment

    2.1 No prior therapy for non-Hodgkin lymphoma including chemotherapy, radiation or immunotherapy (e.g., monoclonal antibody-based therapy)

    2.2 No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease

  3. Age - Patients must be ≥ 18 years of age
  4. ECOG Performance Status - Patients must have ECOG Performance Status 0-2.

  5. Measurable Disease - Measurable disease must be present either on physical examination or imaging studies.

    5.1 Non-measurable disease alone is not acceptable.

    5.2 Any tumor mass > 1 cm is acceptable.

    5.3 Lesions that are considered non-measurable include the following:

    • Bone lesions (lesions if present should be noted)
    • Ascites
    • Pleural/pericardial effusion
    • Lymphangitis cutis/pulmonis
    • Bone marrow (involvement by non-Hodgkin lymphoma should be noted).
  6. CNS Involvement - Patients must have no known CNS involvement by lymphoma.

  7. HIV Infection - Patients must have no known HIV infection.

    7.1 Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus.

    7.2 Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk.

  8. Human Anti-Chimeric Antibody - Patients must have no known baseline human anti-chimeric antibody (HACA) positivity.

  9. Pregnancy and Nursing Status - Patients must be non-pregnant and non-nursing.

    9.1 Due to the unknown teratogenic potential of galiximab, pregnant or nursing patients may not be enrolled.

    9.2 Women and men of reproductive potential should agree to use an effective means of birth control throughout their participation in this study.

    9.3 Appropriate methods of birth control include oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom).

  10. Second Malignancy - Patients with a "currently active" second malignancy, other than non-melanoma skin cancers are not eligible.

    10.1 This includes Waldenstrom's Macroglobulinemia, since such patients have experienced transient increases in IgM following initiation of rituximab, with the potential for hyperviscosity syndrome requiring plasmapheresis.

    10.2 Patients are not considered to have a "currently active" malignancy if they have completed anti-cancer therapy, and are considered by their physician to be at less than 30% risk of relapse.

  11. Required Initial Laboratory Values:

    • ANC ≥ 1000/µL
    • Platelet Count ≥ 50,000/µL
    • Creatinine ≤ 2 x ULN Unless attributable to lymphoma
    • Total Bilirubin ≤ 2 x ULN*† Unless attributable to Gilbert's disease

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall response
Tidsramme: 12 months
complete and partial response will be assessed
12 months

Samarbeidspartnere og etterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

  • Studiestol: Myron S. Czuczman, MD, Roswell Park Cancer Institute

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

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. juni 2005

Primær fullføring (Faktiske)

1. juni 2007

Studiet fullført (Faktiske)

1. august 2013

Datoer for studieregistrering

Først innsendt

8. juli 2005

Først innsendt som oppfylte QC-kriteriene

8. juli 2005

Først lagt ut (Anslag)

11. juli 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

6. juli 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CALGB-50402
  • U10CA031946 (U.S. NIH-stipend/kontrakt)
  • CDR0000433340 (Registeridentifikator: NCI Physician Data Query)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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