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

1. august 2013 opdateret af: French Innovative Leukemia Organisation

An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With Rituximab (MabThera®) in Patients With Follicular Non Hodgkin's Lymphoma With no Prior Treatment

RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as 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 GM-CSF together with rituximab may kill more cancer cells.

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

Studieoversigt

Status

Ukendt

Betingelser

Lymfom

Intervention / Behandling

Detaljeret beskrivelse

OBJECTIVES:

Primary

Evaluate the clinical efficacy of sargramostim (GM-CSF) and rituximab, in terms of overall objective complete and partial response rates, in patients with previously untreated follicular non-Hodgkin lymphoma.

Secondary

Evaluate the time to progression in patients treated with this regimen.
Evaluate the overall survival of patients treated with this regimen.
Evaluate the duration of response in patients treated with this regimen.
Evaluate the safety profile of this regimen in these patients.
Evaluate the influence of FcγR polymorphisms on clinical response.
Monitor FcγR-expressing cells in peripheral blood during treatment.
Monitor the molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow.

OUTLINE: This is a multicenter study.

Induction therapy: Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and rituximab IV on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Maintenance therapy: Patients receive GM-CSF SC on days 1-5 and rituximab IV on day 1. Treatment repeats every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are collected at baseline and periodically during study for analysis of bcl2 rearrangement by PCR assay; FcγR expression by immunophenotyping; and FcγR polymorphisms.

After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Fase 2

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

DISEASE CHARACTERISTICS:

Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification
- Grade 1-3a disease
- Stage II-IV disease
- Non-bulky disease
Must have undergone initial nodal biopsy within the past 4 months
At least 1 measurable lesion
Low tumor-burden, as defined by the following GELF criteria:
- Nodal or extranodal tumor mass (diameter < 7 cm)
- No systemic B symptoms
- No increased LDH and β2 microglobulinemia
- No substantial splenic enlargement
- No serous effusion
- No compression syndrome

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Negative pregnancy test
Fertile patients must use effective contraception
No active hepatitis

PRIOR CONCURRENT THERAPY:

No prior treatment, including steroids and radiotherapy

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
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Overall objective tumor response rate at the end of induction therapy

Sekundære resultatmål

Resultatmål
Tid til progression
Samlet overlevelse
Varighed af svar
Sikkerhedsprofil
Tid til næste behandling
Influence of FcγR polymorphisms on clinical response and survival
FcγR expression during study treatment
Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay

Samarbejdspartnere og efterforskere

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

Sponsor

French Innovative Leukemia Organisation

Efterforskere

Ledende efterforsker: Jean-Francois Rossi, MD, PhD, Hopital Lapeyronie-CHU Montpellier

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. marts 2009

Primær færdiggørelse (Forventet)

1. marts 2011

Datoer for studieregistrering

Først indsendt

5. maj 2009

Først indsendt, der opfyldte QC-kriterier