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Rituximab Maintenance Versus Observation After R2 Induction in Previously Untreated Marginal Zone Lymphoma (ROMA)

12 juni 2026 uppdaterad av: Qingqing Cai, Sun Yat-sen University

Rituximab Maintenance Versus Observation After Rituximab and Lenalidomide (R2) Induction in Previously Untreated Marginal Zone Lymphoma: A Multicenter, Phase 2, Randomized Trial

This is a multicenter, phase 2, randomized trial to compare rituximab maintenance with observation after rituximab and lenalidomide (R2) induction therapy in patients with previously untreated marginal zone lymphoma. Patients who achieve complete response or partial response after R2 induction will be randomized to receive rituximab maintenance or observation.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

144

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Sun Yat-sen University Cancer Center
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Able to understand and voluntarily sign the informed consent form.
  • Age ≥18 years.
  • Histologically confirmed CD20-positive marginal zone lymphoma, including extranodal, splenic, or nodal subtypes.
  • Considered unsuitable for or unable to tolerate standard chemotherapy.
  • Previously untreated with systemic anti-lymphoma therapy.
  • Measurable or evaluable disease according to Lugano 2014 criteria.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Adequate organ function.

Exclusion Criteria:

  • History of other malignancies that may interfere with study assessment.
  • Central nervous system involvement by lymphoma.
  • Known HIV infection or active hepatitis B/C infection.
  • Active or uncontrolled infection.
  • Gastrointestinal condition that may interfere with oral administration or absorption of study treatment.
  • Pregnancy or breastfeeding.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Rituximab
Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: maintenance therapy with rituximab every 8 weeks for 2 years.
Läkemedel: Rituximab
Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will receive rituximab maintenance every 8 weeks for up to 2 years.
Aktiv komparator: Observation
Patients will receive induction therapy with rituximab and lenalidomide. If CR or PR: observation.
Övrig: Observation
Patients will receive R2 induction therapy consisting of rituximab and lenalidomide. Patients who achieve complete response or partial response after induction will undergo observation without maintenance anti-lymphoma therapy.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
2-year progression-free survival rate
Tidsram: At 2 years after randomization
The 2-year progression-free survival rate is defined as the proportion of patients who are alive without disease progression at 2 years after randomization.
At 2 years after randomization

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Complete response rate
Tidsram: Up to 24 months after randomization
Complete response rate is defined as the proportion of patients who achieve complete response according to the Lugano 2014 criteria during the maintenance or observation period.
Up to 24 months after randomization
Overall response rate
Tidsram: Up to 24 months after randomization
Overall response rate is defined as the proportion of patients who achieve complete response or partial response according to the Lugano 2014 criteria during the maintenance or observation period.
Up to 24 months after randomization
Duration of response
Tidsram: Up to 24 months after randomization
Duration of response is defined as the time from the first documented complete response or partial response to disease progression, relapse, or death from any cause, whichever occurs first.
Up to 24 months after randomization
Overall survival
Tidsram: Up to 24 months after randomization
Overall survival is defined as the time from randomization to death from any cause.
Up to 24 months after randomization
Event-free survival
Tidsram: Up to 24 months after randomization
Event-free survival is defined as the time from randomization to disease progression, relapse, initiation of new systemic anti-lymphoma therapy, or death from any cause, whichever occurs first.
Up to 24 months after randomization
Disease-free survival
Tidsram: Up to 24 months after randomization
Disease-free survival is defined as the time from the first documented complete response to disease relapse, progression, or death from any cause, whichever occurs first.
Up to 24 months after randomization
Incidence of progression of disease within 24 months
Tidsram: Within 24 months from the start of induction therapy
POD24 is defined as the proportion of patients who experience disease progression, relapse, or death from any cause within 24 months from the start of frontline induction therapy.
Within 24 months from the start of induction therapy
Patient-reported outcomes
Tidsram: Up to 24 months after randomization
Patient-reported outcomes will be assessed using the EORTC QLQ-C30 questionnaire.
Up to 24 months after randomization
Incidence of adverse events and serious adverse events
Tidsram: Up to 30 days after the last study treatment or during follow-up as clinically indicated
The incidence and severity of adverse events and serious adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Up to 30 days after the last study treatment or during follow-up as clinically indicated

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sun Yat-sen University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juli 2026

Primärt slutförande (Beräknad)

1 juli 2030

Avslutad studie (Beräknad)

1 juli 2031

Studieregistreringsdatum

Först inskickad

12 juni 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • B2026-335

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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