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Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

1 luglio 2016 aggiornato da: Alliance for Clinical Trials in Oncology

A Phase II Trial of Extended Induction Epratuzumab (Anti-CD22 Monoclonal Antibody) (CALGB IND #XXXXX) Plus Rituximab in Previously Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

RATIONALE: Monoclonal antibodies, such as epratuzumab and rituximab, 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 epratuzumab and rituximab together may be more effective in treating follicular non-Hodgkin lymphoma.

PURPOSE: This phase II trial is studying how well giving epratuzumab together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

OBJECTIVES:

Primary

  • To determine the response rate (overall and complete) after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular non-Hodgkin lymphoma (NHL).
  • To determine the time to progression after extended induction therapy comprising epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.

Secondary

  • To determine the toxicity profile of epratuzumab and rituximab in patients with previously untreated CD20+ follicular NHL.
  • To establish whether the therapeutic effects of the combination of epratuzumab and rituximab are sufficiently promising to warrant evaluation in a subsequent randomized trial (in comparison to rituximab alone).
  • To determine the relationship between the change in fludeoxyglucose F 18 uptake early after epratuzumab and rituximab treatment with response rate and time to progression.

OUTLINE:

  • Induction therapy (month 1): Patients receive epratuzumab IV over 5-30 minutes on days 1, 8, 15, and 22 and rituximab IV on days 3, 8, 15, and 22 in the absence of disease progression or unacceptable toxicity.
  • Extended induction therapy (months 3, 5, 7, and 9): Patients receive epratuzumab IV over 5-30 minutes followed by rituximab IV in weeks 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.

Patients receive fludeoxyglucose F 18 (FDG) subcutaneously and undergo positron emission tomography at baseline and after induction therapy to assess the degree of FDG uptake.

After completion of study treatment, patients are followed every 4 months for 2 years then every 6 months for up to 10 years.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • California
      • San Diego, California, Stati Uniti, 92120
        • Kaiser Permanente Medical Office -Vandever Medical Office
      • San Francisco, California, Stati Uniti, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
    • Connecticut
      • Middletown, Connecticut, Stati Uniti, 06457
        • Middlesex Hospital Cancer Center
    • Delaware
      • Lewes, Delaware, Stati Uniti, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, Stati Uniti, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
      • Washington, District of Columbia, Stati Uniti, 20307-5001
        • Walter Reed Army Medical Center
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Stati Uniti, 60612-7243
        • University of Illinois Cancer Center
    • Indiana
      • Elkhart, Indiana, Stati Uniti, 46515
        • Elkhart General Hospital
      • Fort Wayne, Indiana, Stati Uniti, 46845
        • Fort Wayne Medical Oncology and Hematology
      • Kokomo, Indiana, Stati Uniti, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Stati Uniti, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • South Bend, Indiana, Stati Uniti, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Stati Uniti, 46601
        • CCOP - Northern Indiana CR Consortium
      • South Bend, Indiana, Stati Uniti, 46617
        • Saint Joseph Regional Medical Center
      • South Bend, Indiana, Stati Uniti, 46617
        • South Bend Clinic
    • Iowa
      • Bettendorf, Iowa, Stati Uniti, 52722
        • Hematology Oncology Associates of the Quad Cities
    • Maryland
      • Elkton MD, Maryland, Stati Uniti, 21921
        • Union Hospital Cancer Program at Union Hospital
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Stati Uniti, 02115
        • Dana-Farber/Brigham and Women's Cancer Center
    • Michigan
      • Saint Joseph, Michigan, Stati Uniti, 49085
        • Oncology Care Associates, PLLC
      • St. Joseph, Michigan, Stati Uniti, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Saint Louis, Missouri, Stati Uniti, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
    • New Hampshire
      • Concord, New Hampshire, Stati Uniti, 03301
        • New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
      • Hooksett, New Hampshire, Stati Uniti, 03106
        • New Hampshire Oncology - Hematology, PA - Hooksett
      • Laconia, New Hampshire, Stati Uniti, 03246
        • Lakes Region General Hospital
      • Lebanon, New Hampshire, Stati Uniti, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Voorhees, New Jersey, Stati Uniti, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New York
      • East Syracuse, New York, Stati Uniti, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
      • New York, New York, Stati Uniti, 10021
        • New York Weill Cornell Cancer Center at Cornell University
    • North Carolina
      • Goldsboro, North Carolina, Stati Uniti, 27534
        • Wayne Memorial Hospital, Incorporated
      • Kinston, North Carolina, Stati Uniti, 28501
        • Kinston Medical Specialists
      • Statesville, North Carolina, Stati Uniti, 28677
        • Iredell Memorial Hospital
      • Winston-Salem, North Carolina, Stati Uniti, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • Ohio
      • Columbus, Ohio, Stati Uniti, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
    • Vermont
      • Berlin, Vermont, Stati Uniti, 05602
        • Mountainview Medical
      • Burlington, Vermont, Stati Uniti, 05401
        • Fletcher Allen Health Care - University Health Center Campus
    • Virginia
      • Danville, Virginia, Stati Uniti, 24541
        • Danville Regional Medical Center
      • Martinsville, Virginia, Stati Uniti, 24115
        • Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
      • Richmond, Virginia, Stati Uniti, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
    • West Virginia
      • Huntington, West Virginia, Stati Uniti, 25702
        • St. Mary's Regional Cancer Center at St. Mary's Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

DISEASE CHARACTERISTICS:

  • Histologically* confirmed follicular non-Hodgkin lymphoma (NHL)

    • Previously untreated disease
    • WHO classification grade 1, 2, or 3a (> 15 centroblasts per high power field with centrocytes present) that is stage III, IV, or bulky (i.e., single mass ≥ 7 cm in any unidimensional measurement) stage II disease NOTE: *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 for diagnosis
  • Confirmed CD20 antigen expression by flow cytometry or immunohistochemistry

  • Measurable disease by physical examination or imaging studies

    • Any tumor mass > 1 cm is acceptable

    • No nonmeasurable disease only, including any of the following:

      • Bone lesions
      • Ascites
      • Pleural/pericardial effusion
      • Lymphangitis cutis/pulmonis
      • Bone marrow (involvement by NHL should be noted)
  • No known CNS involvement by lymphoma
  • Required to participate in companion FDG-PET imaging study CALGB 580701

PATIENT CHARACTERISTICS:

  • ECOG performance status ≤ 2
  • Absolute neutrophil count ≥ 1,000/μL
  • Platelet count ≥ 50,000/μL

  • Patients with HIV infection are eligible provided they meet the following criteria:

    • No evidence of coinfection with hepatitis B or C
    • CD4+ cell count ≥ 400/mm^3
    • No evidence of resistant strains of HIV
    • If not on anti-HIV therapy, HIV viral load < 10,000 copies HIV RNA/mL
    • If on anti-HIV therapy, HIV viral load < 50 copies HIV RNA/mL
    • No history of AIDS-defining conditions
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy
  • No known Human Anti-Chimeric Antibody (HACA)-positivity

PRIOR CONCURRENT THERAPY:

  • No prior therapy for NHL including chemotherapy, radiotherapy, or immunotherapy (e.g., monoclonal antibody-based therapy)
  • More than 2 weeks since prior corticosteroids except for maintenance therapy for non-malignant disease

  • No concurrent dexamethasone or other steroids as antiemetics except for the following circumstances:

    • Treatment of acute infusion reactions according to institutional procedures
  • No concurrent hormonal therapy except steroids for adrenal failure OR hormones for non-disease-related conditions (e.g., insulin for diabetes)
  • No other concurrent chemotherapeutic agents

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Epratuzumab Plus Rituximab

Induction Therapy (Month 1): Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22

Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36
Biologico: epratuzumab
Days 1, 8, 15, 22 and weeks 12, 20, 28, & 36: 360mg/sq m IV
Biologico: rituximab
Day 3, 8, 15, 22 and weeks 12, 20, 28, & 36: 375mg/sq m IV

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Overall Response
Lasso di tempo: 12 months

Overall response is defined as achievement of a complete response (CR) or partial response (PR) as defined by the Revised Response Criteria for Malignant Lymphoma.

CR: complete disappearance of all detectable disease PR: >=50% decrease in the sum of the product of diameters of indicator lesions
12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival
Lasso di tempo: Duration of study (up to 10 years)
Progression free survival (PFS) was defined as the time from registration to progression or death of any cause. Progression free and alive patients were censored at the date of last follow-up. The median PFS with 95% CI was estimated using the Kaplan Meier method.
Duration of study (up to 10 years)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alliance for Clinical Trials in Oncology

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Cattedra di studio: Barbara Grant, MD, University of Vermont

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 marzo 2008

Completamento primario (Effettivo)

1 luglio 2010

Completamento dello studio (Effettivo)

1 luglio 2014

Date di iscrizione allo studio

Primo inviato

2 novembre 2007

Primo inviato che soddisfa i criteri di controllo qualità

2 novembre 2007

Primo Inserito (Stima)

4 novembre 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 luglio 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 luglio 2016

Ultimo verificato

1 luglio 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CALGB-50701
  • U10CA031946 (Sovvenzione/contratto NIH degli Stati Uniti)
  • CDR0000572604 (Identificatore di registro: NCI Physician Data Query)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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