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New drug combo shows promise for rare lymphoma

NCT ID NCT01808599

Disease control Sponsor: International Extranodal Lymphoma Study Group (IELSG) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two drugs, chlorambucil and rituximab, followed by ongoing rituximab maintenance, in 112 people with MALT lymphoma, a slow-growing cancer of the lymph nodes. The goal is to see how many patients achieve complete remission. Participants must have a specific type of MALT lymphoma and may have had prior local treatments like surgery or radiation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

112 people

The number who actually took part.

Start date

Dec 2013

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma) arisen at any extranodal site 1.1 The following patients with gastric MALT Lymphoma can be entered: * H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics). * H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including * Patients with clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication * Stable disease with persistent lymphoma at ≥ 1 year post H. pylori eradication * Relapse (without H. pylori re-infection), after a remission * Patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy) 1.2 Similar consideration may be applied to patients with ocular adnexal lymphoma treated with antibiotics. 2. Measurable or evaluable disease. Measurable disease in at least two perpendicular dimensions on an imaging scan is defined as: lymph node or nodal mass bi-dimensional measurement with \> 1.5 cm in longest transverse diameter or the short diameter must measure \> 10 mm regardless of the longest transverse diameter. 3. Any stage (Ann Arbor I-IV) (see Appendix A) 4. Age ≥ 18 5. Life expectancy of at least 1 year 6. ECOG performance status 0-2 (see Appendix B) 7. Adequate bone marrow function (WBC \>3.0x109/L, ANC \>1.5x109/L, PLT \>100x109/L), unless due to lymphoma involvement 8. Adequate kidney (serum creatinine \<1,5x upper normal) and liver function (ASAT/ALAT \<2,5 upper normal, total bilirubin \<2,5x upper normal), unless due to lymphoma involvement 9. For women of childbearing potential only: negative serum pregnancy test done within 7 days prior to study drugs administration or within 14 days if with a confirmatory urine pregnancy test within 7 days prior to the first study drugs administration 10. Fertile male or female patients of childbearing potential and their partners must use two forms of contraception during the study and for at least 12 months after the last dose of subcutaneous rituximab. For appropriate methods of contraception considered acceptable, see Appendix C. Should a woman become pregnant or suspect she is pregnant while she or her partner are participating in this study and for 12 months after study participation, the patient should inform the treating physician immediately. Female patients of childbearing potential are defined as follows: * Pre-menopausal women (patients with regular menstruation, patients after menarche with amenorrhea or irregular cycles, patients using a contraceptive method that precludes withdrawal bleeding * Women who have had tubal ligation Female patients may be considered to NOT be of childbearing potential for the following reasons: * The patient has undergone total abdominal hysterectomy with bilateral salpingo-oophorectomy or bilateral oophorectomy * The patient is medically confirmed to be menopausal (no menstrual period) for 24 consecutive months 11. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: 1. Evidence of histologic transformation to a high grade lymphoma 2. Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer 3. Prior chemotherapy 4. Prior immunotherapy with any anti-CD20 monoclonal antibody 5. Prior radiotherapy in the last 6 weeks 6. Use of corticosteroids during the last 28 days, unless prednisone chronically administered at a dose \<20 mg/day for indications other than lymphoma or lymphoma-related symptoms 7. Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry 8. Evidence of symptomatic central nervous system (CNS) disease 9. Evidence of active opportunistic infections 10. Known HIV infection 11. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the subject will be excluded 12. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, confirmed by HC RIBA immunoblot assay on the same sample. 13. Pregnant or lactating status 14. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial 15. Fertile men or women of childbearing potential who do not agree to use a highly effective measure of contraception (such as oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) throughout the study and for at least 12 months after the last dose of subcutaneous rituximab

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Conditions

The condition(s) this trial relates to.

Lymphoma, B-Cell, Marginal Zone MALT lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Malt lymphoma

Contacts and locations

Locations

  • AO SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, Italy

  • ARNAS Garibaldi Catania

    Catania, Italy

  • Ancona

    Ancona, Italy

  • Arcispedale Santa Maria Nuova, Azienda Ospedaliera di Reggio Emilia

    Reggio Emilia, Italy

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, Italy

  • Azienda Sanitaria AUSL6 Livorno

    Livorno, Italy

  • Biella Ospedale degli Infermi

    Biella, Italy

  • Centro di Riferimento Oncologico di Aviano

    Aviano, Italy

  • Clermont Ferrand CHU Estaing

    Estaing, France

  • Créteil Hopital Henri Mondor

    Créteil, France

  • Dijon CHU Hopital le Bocage

    Dijon, France

  • Ematologia Ospedale Businco (Cagliari)

    Cagliari, Italy

  • Ematologia e CTMO Ospedale Bolzano

    Bolzano, Italy

  • Genova Ematologia I H San Martino

    Genova, Italy

  • Grenoble CHU Pontchaillou

    Grenoble, France

  • IOSI - Oncology Institute of Southern Switzerland

    Bellinzona, 6500, Switzerland

  • IOV Padova

    Padova, Italy

  • IRCCS/CROB Rionero in Vulture

    Rionero in Vulture, Italy

  • Istituto Nazionale dei Tumori, Milano

    Milan, Italy

  • Istituto Regina Elena, Roma, IFO

    Roma, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

    Meldola, Italy

  • Lille CHRU Hopital Claude Dieu

    Lille, France

  • Marseille Paoli Calmettes

    Marseille, France

  • Milano Ospedale Policlinico

    Milan, Italy

  • Montpellier CHU Saint Eloi

    Montpellier, France

  • Nantes CHU Hotel Dieu

    Nantes, France

  • Nocera

    Nocera Umbra, Italy

  • Ospedale Infermi Ematologia Rimini

    Rimini, Italy

  • Paris Hopital Saint Louis

    Paris, France

  • Pierre Bénite CHU Lyon Sud

    Lyon, France

  • Rennes CHU Pontchaillou

    Rennes, France

  • Rouen Centre Henri Becquerel

    Rouen, France

  • SC Ematologia Torino-Molinette

    Torino, Italy

  • SC Oncoematologia Terni

    Terni, Italy

  • Torino Università, Ematologia 1, AO Città della Salute e della Scienza

    Torino, Italy

  • Tours CHU Bretonneau

    Tours, France

  • UO Ematologia Ravenna

    Ravenna, Italy

  • Vandoeuvre lès Nancy CHU Brabois

    Nancy, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.