Study on Bendamustine, Rituximab, and Acalabrutinib for Patients with Untreated Mantle Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Mantle Cell Lymphoma, which is a rare form of non-Hodgkin’s lymphoma. The study is investigating the effectiveness of a treatment combination that includes the drugs Bendamustine, Rituximab, and Acalabrutinib (also known by its code name ACP-196). The purpose of the study is to evaluate how well this combination works compared to Bendamustine and Rituximab alone, with or without a placebo.

Participants in the study will receive treatment over a period of time, during which they will be given the medications either through an intravenous method, which means the drugs are delivered directly into a vein, or orally, which means they are taken by mouth in the form of capsules. The study is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results.

The trial aims to assess the progression-free survival of patients, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. This assessment will be done according to specific guidelines for non-Hodgkin’s lymphoma. The study will help determine if adding Acalabrutinib to the treatment regimen provides any additional benefit to patients with previously untreated Mantle Cell Lymphoma.

1 initial treatment phase

The treatment involves the use of bendamustine and rituximab, administered through intravenous use. This phase is designed to target mantle cell lymphoma, a type of cancer affecting the lymph nodes.

During this phase, bendamustine is given on days 1 and 2 of each 28-day cycle. The dosage and specific administration details will be provided by the healthcare team.

Rituximab is administered on day 1 of each cycle. The healthcare team will monitor the response to treatment and adjust as necessary.

2 combination treatment phase

In addition to bendamustine and rituximab, some patients will receive acalabrutinib in the form of oral capsules. This medication is taken twice daily.

The purpose of adding acalabrutinib is to evaluate its effectiveness in combination with the other medications. The healthcare team will provide guidance on how to take the capsules.

3 monitoring and assessment

Throughout the trial, regular assessments will be conducted to monitor the progression of the lymphoma and the effectiveness of the treatment.

These assessments may include imaging tests and blood tests to evaluate the response to the medications.

4 follow-up phase

After completing the treatment cycles, follow-up visits will be scheduled to continue monitoring the patient’s health and any long-term effects of the treatment.

The duration and frequency of follow-up visits will be determined by the healthcare team based on individual patient needs.

Who Can Join the Study?

  • Men and women who are 65 years of age or older.
  • Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL), which is a type of cancer, with specific genetic markers or proteins present.
  • The MCL must need treatment, and the patient should not have received any previous cancer treatments for it.
  • There must be measurable signs of the disease in the body, such as enlarged lymph nodes or other affected areas.
  • Have an ECOG performance status of 2 or less, which means the patient should be able to carry out all self-care but unable to carry out any work activities. They should be up and about more than 50% of waking hours.
  • Men who are sexually active and can father children must agree to use highly effective birth control during the study and for a certain period after the last dose of the study drugs.
  • Men must also agree not to donate sperm during the study and for a certain period after the last dose of the study drugs.
  • Must be willing and able to participate in all required evaluations and procedures, including being able to swallow capsules without difficulty.
  • Must be able to understand the purpose and risks of the study and provide signed consent to participate and allow the use of their health information.

Who Cannot Join the Study?

  • Patients who have received previous treatment for Mantle Cell Lymphoma. This means if you have already been treated for this type of cancer, you cannot participate.
  • Patients with other serious health conditions that might interfere with the study. This includes any illness that could make it unsafe for you to participate.
  • Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
  • Patients who are unable to follow the study procedures. This means if you cannot attend appointments or follow instructions, you may not be eligible.
  • Patients with a history of allergic reactions to the study medications. If you have had severe allergies to similar drugs, you cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy Warsaw Poland

Verified Sites

Other Sites

Site Name City Country Status
University Hospital Ostrava Ostrava Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich Chorzow Poland
Centre Hospitalier Le Mans Le Mans France
Umrqyaudhx Oj Dzpnmrac Debrecen Hungary
Lhluy Gyxieot Hsyxhgtn Oo Aoafaj Athens Greece
Uyblxuaqvr Grpktxf Hgzcwtuu Oq Irjkgwtp Ioannina Greece
Hhxnefey Voow dlioqamq Barcelona Spain
Vhhdin dkp Rdaby Ullrgquxad Hlqajxze Sevilla Spain
Abzk Garbbo Ojxzyynv Mkjbziwadbtyg Nyzsabxz Milan Italy
Fjojspwtgv Iayeo Phjxkztksda Sso Mlmvaw Pavia Italy
Ayzvtdsfd Hfddddcz Athens Greece
Fehmrhgh Ndycmesez Bdxn Brno Czechia
Hzqqfbvu Uxfyyhbbiojqo Fsqxhzmch Jrlcano Dgnn Madrid Spain
Fiyoofnj Nwjsvhgcm Knercvrjw Vtczpmtub Prague Czechia
Abzbukl Oqqygnmvkhb Uzvwjpqrhgxqm Cxyzmjljehke Dggle Sjzbuv E Drxpz Sojzuoh Dh Thtdeh Turin Italy
Gcvytaq Uonqmqiwhp Hjhxuzez Ov Pjysho Patras Greece
Kkjkdehl dmb Uhteetfzvpsj Medijqmd Ace Munich Germany
Uclvdvbtxw Oe Spohby Szeged Hungary
Cbbroy Hlbiubbatuq Uondlvzvbzvwa Dw Rjckgt Rennes France
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Hgwkwdjv Uynbglgpyuhqt Pznkav Du Hmveip Dl Myksnnbpjid Majadahonda Spain
Ivdjeqsq Cpngrc Ddwjglyzrxpjczyhs L'hospitalet De Llobregat Spain
Fxpxzlwgr Paue Lj Irvxhyihwwajv Beokctkty Ddx Hxmvhlyg Uztaiszapbmwk Lg Plb Madrid Spain
Ctrllin Ojdvgzvva Zdvfb Lvhyjxdjlm Ioy Sqh Jmbr Z Dsryv Lublin Poland
Gdfozj Nyojsylarr Tolhohtkhpmgv Gauvkj Ppeuorsiyvyw Thessaloniki Greece
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Senbfnqf Prwoifoug Sau z odvb Gdynia Poland
Vdwmj Sint-Niklaas Belgium
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Fbggxvow Nkutchtmg Pivul Plzen Czechia
Tevlbkqiqi Cfeeii Hfteukfg Thessaloniki Greece
Ayahmpc Ouyrnypurju Oedchusk Rbtkqfs Vyjpy Syvga Clxdbnng Palermo Italy
Mks Wg Oizvyqnqivdm Pfilcf Aachen Germany
Gtrwwnjrczjpfrwun Vqyssejjp Pcza Agyksa Evmjmtpw Okzqua Ktueoc Gyor Hungary
Jun Yespbxq Zughbhfewv Ieper Belgium
Peocgd Snwq Skorzewo Poland
Afrsxok Uie Iyrdq Dt Rysfoh Euwxnj Reggio Emilia Italy
Achfqux Ohykypgviyp Ukbrakhpqnexx Prokh Parma Italy
Cohrrw Hrsudxhdfte Uabgwyogrqewi Dh Pxgpvaxi Poitiers France
Iodlnsrn Hecnvcnlgyh I Toxxhzrksqidtke Warsaw Poland
Ssboame Swgekkzmevxurwh W Bwmkjmxoq Pupjbuwcdpu Omvnndb Ofgsqecmmies Iousnijedpswmadufuf Brzozow Poland
Hstendal Ugisrmbsbukhs Hxjavutm Tfrkw y Pwtlhs Ivifaqir Cyxvku dgiprpzaoljzqdcnf (zwpl Badalona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
16.03.2017
Czechia Czechia
Not recruiting
16.03.2017
France France
Not recruiting
16.03.2017
Germany Germany
Not recruiting
16.03.2017
Greece Greece
Not recruiting
16.03.2017
Hungary Hungary
Not recruiting
16.03.2017
Italy Italy
Not recruiting
16.03.2017
Poland Poland
Not recruiting
16.03.2017
Spain Spain
Not recruiting
16.03.2017

Trial locations

Bendamustine is a medication used in the treatment of certain types of cancer, including mantle cell lymphoma. It works by interfering with the growth of cancer cells, which are eventually destroyed. In this trial, it is used as part of a combination therapy to evaluate its effectiveness in treating mantle cell lymphoma.

Rituximab is a medication that targets specific proteins on the surface of cancer cells. It is used to treat various types of lymphoma, including mantle cell lymphoma. Rituximab helps the immune system to identify and destroy cancer cells. In this study, it is combined with other medications to assess its role in improving treatment outcomes.

Acalabrutinib (ACP-196) is a newer medication being studied for its potential to treat mantle cell lymphoma. It works by blocking certain enzymes that help cancer cells grow and survive. The trial aims to determine if adding acalabrutinib to the standard treatment of bendamustine and rituximab can improve the effectiveness of the therapy.

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses by spreading to other lymph nodes, bone marrow, and sometimes the spleen or gastrointestinal tract. Patients may experience symptoms such as swollen lymph nodes, fatigue, and weight loss. As the disease advances, it can affect the body’s ability to fight infections. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others.

Trial ID:
2023-509354-58-00
Protocol code:
ACE-LY-308
Trial Phase:
Therapeutic confirmatory (Phase III)

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