Study of BGB-11417 for Patients with Relapsed or Refractory 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, specifically in patients whose disease has returned or has not responded to previous treatments. The trial is testing a new treatment called BGB-11417, which is a medication taken as a film-coated tablet. The purpose of the study is to evaluate the safety and effectiveness of BGB-11417 in treating this condition.

The study is divided into two parts. In the first part, the main goal is to determine how safe and tolerable BGB-11417 is for patients, and to find the best dose to use in the second part of the study. The second part aims to assess how well the treatment works at the recommended dose. Patients will take the medication orally, and the study will monitor their response to the treatment over time.

Throughout the study, researchers will collect information on any side effects experienced by participants and how the drug affects their health. The trial will also look at how the drug is processed in the body, which is known as pharmacokinetics. This information will help determine if BGB-11417 is a suitable treatment option for patients with Mantle Cell Lymphoma that has relapsed or is refractory, meaning it has not responded to other treatments.

1 initial assessment

Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing your medical history and performing necessary tests to ensure you meet the study criteria.

You will be asked to provide consent to participate in the study, acknowledging that you understand the procedures and potential risks involved.

2 treatment initiation

The treatment involves taking a medication called BGB-11417, which is provided in the form of a film-coated tablet.

The medication is taken orally, meaning you will swallow the tablet with water.

3 dose ramp-up

The study begins with a ramp-up dosing schedule to determine the safest and most effective dose for you. This means the dose of BGB-11417 will gradually increase over time.

The specific dosage and frequency will be explained to you by the study team, and you will be monitored closely for any side effects.

4 regular monitoring

Throughout the study, regular monitoring will be conducted to assess your response to the treatment and to ensure your safety.

This includes routine blood tests, physical examinations, and possibly imaging tests to evaluate the status of your condition.

5 follow-up visits

You will have scheduled follow-up visits with the study team to discuss your progress and any concerns you may have.

These visits are important for adjusting the treatment plan if necessary and for collecting data on the effectiveness of the medication.

6 end of treatment

At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the medication.

You will be informed about the next steps, which may include additional follow-up or transitioning to other treatments if needed.

Who Can Join the Study?

Must have a confirmed diagnosis of Mantle Cell Lymphoma (MCL). This means that a doctor has verified the presence of this specific type of cancer.
Must have received previous treatments for MCL, including:
- At least one treatment that targets a protein called CD20, which is often found on the surface of cancer cells.
- At least one treatment with a Bruton Tyrosine Kinase Inhibitor (BTKi), which is a type of medication that blocks certain signals in cancer cells.
The disease must be relapsed (returned after treatment) or refractory (not responding to treatment).
Must have measurable disease, meaning the cancer can be measured in size or amount.
Must have tissue samples available that confirm the diagnosis of MCL, or be willing to have a new biopsy, which is a procedure to take a small sample of tissue for testing.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. This is a scale used to assess how well a person can perform daily activities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
Must have adequate organ function, meaning the organs are working well enough to participate in the study.
Open to both male and female participants.
Participants must be adults.

Who Cannot Join the Study?

Patients who have a different type of cancer other than refractory mantle cell lymphoma cannot participate. Refractory means that the cancer does not respond to treatment.
Patients who are currently receiving treatment for another type of cancer are not eligible.
Patients with severe or uncontrolled medical conditions that could interfere with the study are excluded.
Patients who have had a recent heart attack or have severe heart problems cannot join the study.
Patients with active infections that require treatment are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 4 weeks are excluded.
Patients with known allergies to the study drug or similar drugs cannot join the study.
Patients who have had a major surgery within the last 4 weeks are not eligible.
Patients with a history of drug or alcohol abuse that could interfere with the study are excluded.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Centre Hospitalier Le Mans	Le Mans	France
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Pratia S.A.	Skorzewo	Poland
Assistance Publique Hopitaux De Paris	Paris	France
Universitair Ziekenhuis Gent	Gent	Belgium
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Algemeen Ziekenhuis Delta	Roeselare	Belgium
Isfeivlz Rmkckeiiv Pqz Lw Stbpgy Dko Tgpaly Dhqg Aulusqr Izgt Svmdvt	Meldola	Italy
Uqthqqcekjbulgqxbsumj Dejeorxfuvw Aiu	Duesseldorf	Germany
Ukcyguhhmzxdzn Cppshyp Kghgatnkx	Gdansk	Poland
Hkepnxrn Uqgefslcqmcbg Hupkyvdr Tzudz y Pyjqjo Ixartsft Cupnxw dwofkkgiffkycraja (qarw	Badalona	Spain
Hpabjfjw Vzre dvtzipbs	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	15.12.2022
France	Not recruiting	15.12.2022
Germany	Not recruiting	15.12.2022
Italy	Not recruiting	15.12.2022
Poland	Not recruiting	15.12.2022
Spain	Not recruiting	15.12.2022

Trial locations

Investigated drugs:

N-[4-({[(1R,4R)-4-Hydroxy-4-Methylcyclohexyl]Methyl}Amino)-3- Nitrobenzene-1-Sulfonyl]-4-(2-{(2S)-2-[2-(Propan-2-Yl)Phenyl]Pyrrolidin1-Yl}-7-Azaspiro[3.5]Nonan-7-Yl)-2-[(1H-Pyrrolo[2,3-B]Pyridin-5- Yl)Oxy]Benzamide

BGB-11417 is a medication being studied for its potential to treat a type of cancer called mantle cell lymphoma, which has come back or has not responded to previous treatments. This medication works by blocking a protein that helps cancer cells survive. By inhibiting this protein, BGB-11417 aims to kill the cancer cells or stop them from growing. The study is looking at how safe and tolerable this medication is for patients, as well as determining the best dose to use in future studies. The trial also examines how effective BGB-11417 is in treating this specific type of lymphoma. Patients in the study receive BGB-11417 alone, without any other cancer treatments, to see how well it works on its own.

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, a kind of white blood cell. It typically begins in the lymph nodes but can also affect other areas such as the spleen, bone marrow, and digestive tract. The disease progresses as the cancerous B-cells grow uncontrollably, forming tumors in the lymph nodes and potentially spreading to other parts of the body. As the lymphoma advances, it can lead to symptoms like swollen lymph nodes, fatigue, fever, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others. The disease is considered rare and often requires specialized medical attention.

Trial ID:

2022-500687-35-00

Protocol code:

BGB-11417-201

NCT ID:

NCT05471843

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of BGB-11417 for Patients with Relapsed or Refractory Mantle Cell Lymphoma

What is this study about?

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