Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

16 criteria

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 trial?

14 criteria

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

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Verified sites

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Hospital Universitario Fundacion Jimenez Diaz
Verified
Madrid, Spain

Trial locations

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Investigated drugs

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.

Capivasertib

What is already known about the treatment

Capivasertib - An investigational oral medication being studied for the treatment of relapsed or refractory B-cell Non-Hodgkin Lymphoma. This drug belongs to the class of AKT inhibitors, working by blocking specific cellular signaling pathways involved in cancer cell growth and survival. Capivasertib is administered in tablet form and is currently being evaluated in clinical trials to assess its effectiveness and safety in patients whose lymphoma has returned or stopped responding to previous treatments. The medication works at the molecular level by targeting and inhibiting the AKT protein, which plays a crucial role in cancer cell proliferation and survival.

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.