Study of capivasertib tablets in patients with relapsed or refractory B-cell non-Hodgkin lymphoma

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What is this study about?

This clinical trial focuses on patients with B-cell Non-Hodgkin Lymphoma that has either returned after treatment or did not respond well to previous treatments. The study specifically looks at three types of this blood cancer: Follicular Lymphoma, Marginal Zone Lymphoma, and Mantle Cell Lymphoma. These are different forms of lymphoma, which is a cancer that affects certain white blood cells in the body.

The study will test a medication called capivasertib (also known as TRUQAP) that comes in the form of film-coated tablets taken by mouth. Patients will receive either 160 mg or 200 mg tablets. This medication works by targeting specific processes that cancer cells use to grow and survive.

The main purpose of this study is to determine how well capivasertib works in treating these types of lymphoma by measuring how many patients show improvement after taking the medication. During the study, doctors will monitor patients’ responses to treatment through various medical examinations and imaging tests. They will also track how long any positive responses to the treatment last and evaluate the medication’s safety.

1 Initial medical assessment

Your doctor will confirm the diagnosis of B-cell Non-Hodgkin Lymphoma through medical documentation

A physical examination will be performed to assess your general health status

Your life expectancy should be more than 6 months

If you are female, a pregnancy test will be conducted

2 Medical imaging

You will undergo CT or MRI scanning to measure your disease

The scan must show at least one lymph node larger than 1.5 cm or one lesion outside lymph nodes larger than 1 cm

3 Treatment administration

You will receive TRUQAP tablets for oral use

The medication comes in two strengths: 200 mg and 160 mg film-coated tablets

Your doctor will determine the exact dosage and schedule for taking the medication

4 Regular monitoring

Your response to treatment will be assessed through regular scans

Blood tests will be performed to measure drug levels in your body

You will complete quality of life questionnaires about your symptoms and side effects

Your vital signs will be checked regularly

Heart monitoring through ECG (heart rhythm test) will be performed

5 Treatment duration

The study will continue until June 2025

Your participation may end earlier if your disease progresses or you experience unacceptable side effects

After stopping treatment, your doctor will monitor your health and any subsequent treatments you receive

Who Can Join the Study?

Must be at least 18 years old when signing the consent form
Must have an ECOG performance status of 2 or less (a measure of a person’s ability to perform daily activities)
Must have a life expectancy of more than 6 months
Female patients must not be breastfeeding and must have a negative pregnancy test before starting treatment
For patients with Follicular Lymphoma (FL):
- Must have confirmed FL Grade 1, 2, or 3a
- Must need systemic treatment
- Must have had at least 2 prior treatments that didn’t work
- Must have measurable disease on CT or MRI scans
For patients with Marginal Zone Lymphoma (MZL):
- Must have confirmed splenic, nodal, or extranodal MZL
- Must need systemic treatment
- Must have had at least 2 prior treatments that didn’t work
- Must have measurable disease on CT or MRI scans
For patients with Mantle Cell Lymphoma (MCL):
- Must have confirmed MCL with specific genetic changes
- Must have had at least 2 prior treatments that didn’t work
- Must have previously received BTK inhibitor and anti-CD20 therapy
- Must have measurable disease on CT or MRI scans

Who Cannot Join the Study?

Prior treatment with CAR-T cell therapy (a type of treatment that modifies your immune cells to fight cancer)
Active or untreated brain metastases (cancer that has spread to the brain)
History of another type of cancer within the last 3 years, except for successfully treated skin cancer or early-stage cancer
Severe heart conditions, including:
- Heart failure requiring treatment
- Unstable heart rhythm problems
- Heart attack within the last 6 months
Active, uncontrolled infections requiring treatment
Known HIV, active hepatitis B, or active hepatitis C infection
Pregnancy or breastfeeding
Major surgery within 4 weeks before starting the study treatment
Participation in another clinical trial within 4 weeks before starting this study
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to understand or provide informed consent
Known allergic reactions to study medications or their components

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hvznjskr Vwvf dabgcrzn	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	04.03.2022

Trial locations

Investigated drugs:

Capivasertib

Capivasertib is a targeted therapy medication that works by blocking specific proteins called AKT. It is being studied in patients with B-cell non-Hodgkin lymphoma that has come back or stopped responding to previous treatments. The medication is taken by mouth and works by interfering with signals that cancer cells need to grow and survive.

Investigated diseases:

Non-Hodgkin Lymphoma – A type of blood cancer that develops in the lymphatic system, specifically affecting B-cells, which are important white blood cells that help fight infections. The disease begins when healthy B-cells transform into abnormal cells that grow and multiply uncontrollably, forming tumors in lymph nodes and other parts of the body. In relapsed or refractory cases, the disease either returns after a period of improvement or does not respond adequately to initial treatment. The condition can spread to various parts of the lymphatic system, including lymph nodes, spleen, and bone marrow. The disease can progress at different rates, with some forms developing slowly and others advancing more rapidly.

Trial ID:

2024-516386-36-00

Protocol code:

D361FC00001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of capivasertib tablets in patients with relapsed or refractory B-cell non-Hodgkin lymphoma

What is this study about?

Who Can Join the Study?

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