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Study on Chlorambucil and Rituximab for Patients with MALT Lymphoma

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What is this study about?

This clinical trial is focused on a type of cancer called Extranodal Marginal Zone B-cell Lymphoma of Mucosa Associated Lymphoid Tissue (MALT Lymphoma). The study is investigating the effects of a treatment combination that includes two medications: Chlorambucil and Rituximab. Chlorambucil is given in tablet form, while Rituximab is administered as a solution for injection under the skin, known as subcutaneous injection. The purpose of the study is to evaluate the safety and effectiveness of this treatment combination.

Participants in the study will first receive a combination of Chlorambucil and Rituximab for a period of six months. After this initial phase, they will continue with a maintenance treatment using only Rituximab, which will be given as a subcutaneous injection for an additional two years. This approach aims to manage the lymphoma effectively over a longer period. The study will also include a group receiving a placebo to compare the results.

The trial will monitor various outcomes, such as the rate of complete remission, which means the disappearance of all signs of cancer in response to treatment, and the overall survival of participants. Other aspects being observed include how long participants remain free from disease progression and any side effects that may occur during and after the treatment. The study is designed to provide valuable information on the potential benefits and risks of using Chlorambucil and Rituximab together for treating MALT Lymphoma.

1 induction phase

The initial phase of the study involves a combination treatment with chlorambucil and rituximab. This phase lasts for 6 months.

Chlorambucil is administered orally. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.

Rituximab is given as a subcutaneous injection, which means it is injected under the skin. The dosage and frequency will be specified by the healthcare provider.

2 maintenance phase

Following the induction phase, the study continues with a maintenance phase lasting 2 years.

During this phase, rituximab is administered alone as a subcutaneous injection. The frequency of these injections will be determined by the healthcare provider.

3 evaluation and follow-up

Throughout the study, regular evaluations will be conducted to monitor the response to treatment and any side effects.

The primary goal is to assess the complete remission rate at the end of the 6-month induction phase.

Secondary evaluations include response rates, progression-free survival, event-free survival at 5 years, overall survival, response duration, and both acute and long-term toxicity.

Who Can Join the Study?

  • You must have a confirmed diagnosis of Extranodal Marginal Zone Lymphoma. This is a type of cancer that affects certain white blood cells and occurs outside of the lymph nodes.
  • The lymphoma must be CD20-positive. This means that the cancer cells have a specific protein on their surface that can be targeted by certain treatments.
  • The lymphoma should be of the MALT type. MALT stands for Mucosa-Associated Lymphoid Tissue, which is a type of tissue found in various parts of the body.
  • The lymphoma can be either a new diagnosis (de novo) or have returned after previous local treatments like surgery, radiation, or antibiotics for a specific stomach infection.
  • You must have a measurable or evaluable disease. This means that the cancer can be measured or assessed by doctors to see how it responds to treatment.
  • The lymphoma can be at any stage from I to IV, according to the Ann Arbor staging system, which is a way to describe how much the cancer has spread.
  • You must be 18 years or older to participate.
  • Both men and women are eligible to participate in the study.

Who Cannot Join the Study?

  • Patients who have a different type of lymphoma other than Extranodal Marginal Zone Lymphoma cannot participate. This is a specific type of cancer that affects certain immune system cells.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate. This includes conditions that could make it unsafe for them to take the study medications.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who have participated in another clinical trial recently may not be eligible. This is to avoid any interference with the study results.
  • Patients who have allergies to the study medications, such as Chlorambucil or Rituximab, cannot participate. These are the drugs being tested in the study.
  • Patients who have a history of certain infections or diseases that could affect the study results cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Lille Lille France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Azienda Ospedaliera S Maria Di Terni Terni Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Azienda Socio Sanitaria Territoriale Dei Sette Laghi Varese Italy
Azienda Sanitaria Locale Di Pescara Pescara Italy
Centre Henri Becquerel Rouen France
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milan Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universita’ Politecnica Delle Marche Ancona Italy
Centre Hospitalier Universitaire De Nantes Nantes France
ARNAS G. Brotzu Cagliari Italy
Centre Hospitalier Universitaire De Rennes Rennes France
Azienda USL Toscana Sud Est Arezzo Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Azienda Sanitaria Locale Della Provincia Di Biella Ponderano Italy
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
IRCCS CROB Rionero In Vulture Italy
Azienda Sanitaria Locale Di Salerno Battipaglia Italy
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Iqliqp Ihclphpl Fcxwemdvrvcfn Omhswhgjcrx Rome Italy
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Cgtrwg Hhswbeypgka Urydmaduzxzgi Dl Dxrcn Dijon France
Itmkxewo Rbzrhvbhg Pwu Le Seojyz Drg Txtldq Dwfp Ajzsemx Ioiu Sgubgx Meldola Italy
Cmghan Hnobmeduaty Rmjbushm Uvgvdlpbsvdnd Ds Thnhg Tours France
Aoqpcrz Ovdouovkwbr Uxeisrqeboyxx Crnzihuqqjlv Dggeq Sghzrv E Dttft Szhhdte Dt Tsfeyp Turin Italy
Cglk De Nxsnh Vandoeuvre Les Nancy France
Amvijzf Olqmzkzdjsy Ntcytdjdl Si Ajajptj E Boikcn E C Ardaxa Ajspvehxpdd Alexandria Italy
Adctujq Uen Iqucz Dq Rivlfy Eltjem Reggio Emilia Italy
Uzrmikhwzl Dpszz Soplz Ds Rhkz Lo Sccorgak Rome Italy
Icrecmql Pnyecyhxhwcgeuy Cclwbr Crbkod Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
27.03.2014
Italy Italy
Not recruiting
27.03.2014

Trial locations

Investigated drugs:

Chlorambucil is a medication used in this study to help treat a type of cancer called MALT lymphoma, which affects certain immune system cells. It works by slowing or stopping the growth of cancer cells. In this trial, Chlorambucil is combined with another medication to see how well they work together.

Rituximab is another medication used in this study. It is given as an injection under the skin and is used to target and destroy specific cancer cells in MALT lymphoma. In the trial, Rituximab is first combined with Chlorambucil for six months to see how effective the combination is. After that, Rituximab is continued alone for two years as a maintenance therapy to help keep the cancer from coming back.

Investigated diseases:

Extranodal Marginal Zone Lymphoma – This is a type of non-Hodgkin lymphoma that originates in the marginal zone of lymphoid tissue, often affecting areas outside the lymph nodes, such as the stomach, lungs, or thyroid. It is part of a group of diseases known as MALT (mucosa-associated lymphoid tissue) lymphomas. The disease typically progresses slowly and may remain localized for a long time before spreading. Symptoms can vary depending on the affected area but may include swelling, pain, or discomfort in the involved organ. It is considered a rare disease and is often diagnosed in middle-aged or older adults.

Trial ID:
2023-507291-52-00
Protocol code:
IELSG38
NCT ID:
NCT01808599
Trial Phase:
Therapeutic exploratory (Phase II)

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