Study of Venetoclax, Ibrutinib, and Rituximab or Bendamustine Combination for Patients with Untreated Mantle Cell Lymphoma Not Suitable for High-Dose Therapy

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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 exploring the effectiveness of different treatment combinations for patients who have not received prior treatment and are not eligible for high-dose therapy. The treatments being tested include a combination of medications: Venetoclax (also known by its code name ABT-199), Ibrutinib, and Rituximab, as well as a conventional chemotherapy regimen that includes Bendamustine, Ibrutinib, and Rituximab. Venetoclax and Ibrutinib are taken orally, while Bendamustine and Rituximab are administered through intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to evaluate how well these treatment combinations work in terms of failure-free survival, which refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. The study will follow participants over a period of time to see how long they remain free from disease progression. Participants will receive one of the treatment combinations and will be monitored regularly to assess their response to the treatment and any side effects they may experience. The study aims to provide valuable information on the effectiveness and safety of these treatment options for patients with Mantle Cell Lymphoma.

Throughout the study, researchers will also look at other important outcomes, such as progression-free survival, which is the time during and after treatment that a patient lives without the disease worsening, and overall survival, which is the time a patient lives from the start of the study. Additionally, the study will assess the quality of life of participants during the treatment period. This research is important for understanding how these treatments can help manage Mantle Cell Lymphoma and improve the lives of those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of mantle cell lymphoma and ensuring other health criteria are met.

2 treatment allocation

Participants are assigned to one of two treatment groups. One group receives a combination of venetoclax, ibrutinib, and rituximab. The other group receives bendamustine, ibrutinib, and rituximab.

3 medication administration

For the group receiving venetoclax, the medication is taken orally in the form of film-coated tablets. Ibrutinib is administered as hard capsules taken orally. Rituximab is given through an intravenous infusion.

For the group receiving bendamustine, the medication is administered via intravenous infusion. Ibrutinib and rituximab are administered in the same manner as the other group.

4 treatment duration

The treatment is conducted over a specified period, with regular monitoring to assess the effectiveness and safety of the medications. The primary goal is to evaluate failure-free survival at 30 months.

5 monitoring and follow-up

Throughout the trial, participants undergo regular health assessments to monitor progress and any side effects. This includes evaluating overall survival, response rates, and quality of life.

6 completion of trial

The trial is expected to conclude by September 2028. Final assessments will be conducted to determine the long-term efficacy and safety of the treatments.

Who Can Join the Study?

Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL) according to the World Health Organization (WHO) classification.
Creatinine level must be less than or equal to 2 mg/dL, or estimated Glomerular Filtration Rate (eGFR) must be at least 50 mL/min. Creatinine and eGFR are measures of kidney function.
Must provide a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
Sexually active men with female partners who can become pregnant must agree to use highly effective birth control methods.
Must not have received previous treatment for MCL and be in stage II-IV according to the Ann Arbor staging system, which describes the extent of cancer spread.
Must be at least 60 years old and not suitable for a procedure called autologous stem cell transplant (SCT).
Must have at least one measurable lesion, which is an area of cancer that can be measured. If the cancer is only in the bone marrow, a bone marrow aspiration and biopsy are required for all evaluations.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less. This is a scale that measures how well you can perform daily activities.
Must have an absolute neutrophil count (ANC) of at least 1000 cells per microliter. Neutrophils are a type of white blood cell important for fighting infections.
Must have a platelet count of at least 75,000 cells per microliter. Platelets are cells that help with blood clotting.
Must have transaminase levels (AST and ALT) that are no more than 3 times the upper limit of normal (ULN). AST and ALT are enzymes that indicate liver function.
Total bilirubin must be no more than 2 times the ULN unless there is another known reason, such as Gilbert-Meulengracht Syndrome, which is a common and harmless liver condition.

Who Cannot Join the Study?

Patients with other types of cancer besides Mantle Cell Lymphoma cannot participate. Mantle Cell Lymphoma is a specific type of cancer that affects the lymph nodes.
Patients who have not failed previous treatments for Mantle Cell Lymphoma are excluded. This means the study is for those whose previous treatments did not work.
Patients who are under 18 years old or over 65 years old cannot join the study. The study is only for adults within this age range.
Patients who are pregnant or breastfeeding are not allowed to participate. This is to ensure the safety of both the mother and the baby.
Patients with serious health conditions that could interfere with the study are excluded. This includes conditions that might make it unsafe for them to participate.
Patients who are unable to follow the study procedures or attend regular check-ups are not eligible. This is important for the accuracy and safety of the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Rostock University Medical Center	Rostock	Germany
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Azienda Sanitaria Universitaria Giuliano Isontina	Trieste	Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Azienda Unita Sanitaria Locale Di Piacenza	Piacenza	Italy
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Kliniken Maria Hilf GmbH Moenchengladbach	Moenchengladbach	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH	Trier	Germany
Universitaetsklinikum Brandenburg an der Havel GmbH	Brandenburg An Der Havel	Germany
ARNAS Garibaldi Di Catania	Catania	Italy
Johannes Wesling Klinikum Minden	Minden	Germany
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts	Mutlangen	Germany
OncoResearch Lerchenfeld GmbH	Hamburg	Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbH	Essen	Germany
Saarland University Hospital	Homburg	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbH	Paderborn	Germany
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Kliniken Suedostbayern AG	Traunstein	Germany
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universita Degli Studi Di Brescia	Brescia	Italy
Ucobcbpgxf Mscvsmc Chycki Hpxmnbxfuifooispa	Hamburg	Germany
Ucjabekjifzjalddekqie Emkto Aig	Essen	Germany
Gnwpxwsntyeqjkfbkopsn Mrnpbiaozfl gevel	Koblenz	Germany
Axmdege Ooizsmdocfm Uquelafsaiyll Crtpbdfaiasn Drnav Szudvs E Dfeep Syisdyx Dk Tnpstq	Turin	Italy
Akuliji Ocewgkxbpgv Nlbzqlmwe Sn Aqoughg E Bfgygn E C Adiynz Actiwbzpoiq	Alexandria	Italy
Kjunrrme dto Uwnkchmuiyuz Mihqoxrh Abj	Munich	Germany
Avslqeu Ukfns Sktwxvrdz Lnaguw Dy Bhoqwvw	Bologna	Italy
Kgbte Ssa Piccsk Grlp	Dortmund	Germany
Unvjjpskcl Dcapr Stxwy Dk Rcst Lm Shyqsryz	Rome	Italy
Myxptedmjwpdtpwnjptjjpxntq Hsqhbmzkxvlyxccw	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	31.03.2023
Italy	Recruiting	31.03.2023

Trial locations

Investigated drugs:

Venetoclax is a medication used to help treat certain types of blood cancers. It works by targeting and blocking a specific protein that cancer cells need to survive, which can help to kill the cancer cells and slow down the progression of the disease.

Ibrutinib is a type of medication known as a BTK inhibitor. It is used to treat certain blood cancers by blocking a protein that helps cancer cells grow and divide. This can help to stop the spread of cancer and reduce symptoms.

Rituximab is a medication that targets specific cells in the immune system. It is used to treat certain types of blood cancers by helping the immune system to destroy cancer cells. It can also help to reduce the size of tumors and slow the progression of the disease.

Bendamustine is a type of chemotherapy used to treat certain types of blood cancers. It works by damaging the DNA of cancer cells, which can prevent them from growing and dividing. This can help to reduce the number of cancer cells in the body and slow the progression of the disease.

Investigated diseases:

Mantle cell lymphoma

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, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others. It is considered a challenging condition due to its tendency to be diagnosed at an advanced stage.

Trial ID:

2022-501808-96-00

Protocol code:

20-01434

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Venetoclax, Ibrutinib, and Rituximab or Bendamustine Combination for Patients with Untreated Mantle Cell Lymphoma Not Suitable for High-Dose Therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?