RecruitingRare disease

Study of Glofitamab and Pirtobrutinib Treatment in Patients with Mantle Cell Lymphoma Who Have Failed Previous Therapy and in Previously Untreated Patients

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 Mantle Cell Lymphoma (MCL), a type of blood cancer that affects white blood cells. The study evaluates a combination treatment using three medications: glofitamab, pirtobrutinib, and obinutuzumab. Glofitamab and obinutuzumab are given through an infusion into a vein, while pirtobrutinib is taken as a tablet by mouth.

The purpose of this research is to determine how effective the combination of glofitamab and pirtobrutinib is in treating patients with Mantle Cell Lymphoma, both in those who have previously received treatment and in those who have never been treated before. The study includes two groups of patients: those whose disease has returned or worsened after previous treatments, and elderly patients who have not yet received any treatment for their condition.

During the study, patients will receive treatment for up to 36 months. The treatment involves regular doses of medication according to a specific schedule. Patients will be monitored throughout the study period to assess how well the treatment is working and to check for any side effects. The study team will track whether the cancer improves, stays the same, or gets worse over time.

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 treatment phase
You will receive three medications during the treatment: obinutuzumab, glofitamab, and pirtobrutinib
Two medications will be given through an intravenous infusion (directly into your vein): obinutuzumab and glofitamab
One medication (pirtobrutinib) will be taken by mouth
Step 2
Treatment monitoring at 8 months
Your response to the treatment will be evaluated after completing the glofitamab treatment, before cycle 13
A PET scan (special imaging test) will be performed to check how well the treatment is working
Your doctor will assess if you have achieved a complete or partial response to the treatment
Step 3
Continued treatment phase
Treatment will continue if you are responding well and not experiencing significant side effects
Regular monitoring of your health status will continue throughout the treatment
Step 4
24-month evaluation
A major evaluation of your progress will occur at 24 months from the start of treatment
Another PET scan will be performed before cycle 30
Your doctor will assess if the disease has progressed
Side effects will continue to be monitored and documented
Step 5
Safety monitoring
Throughout the entire treatment period, you will be monitored for side effects
Special attention will be paid to specific reactions including CRS (a type of immune response) and ICANS (effects on the nervous system)
Any side effects will be graded according to standardized criteria to ensure proper management

Who can join the trial?

13 criteria

Must be at least 18 years old for patients with relapsed/recurring disease, or 65 years or older (or 60+ if not suitable for intensive treatment) for previously untreated patients
Must have confirmed Mantle Cell Lymphoma with specific genetic markers
Disease must be at stage II-IV with at least one measurable tumor (larger than 1.5 cm if in lymph nodes, or larger than 1 cm if outside lymph nodes)
Must have acceptable blood test results, including: - Adequate platelet count - Sufficient hemoglobin levels - Normal kidney function - Acceptable liver function - Normal blood clotting
Must have good heart and lung function, including: - Heart pumping strength of at least 45% - No significant fluid around heart or lungs - Normal oxygen levels when breathing room air
Must have good physical function (able to perform daily activities with minimal assistance)
Must be able to take oral medications
Must agree to use effective birth control methods during the study and for 6 months after
Women who can become pregnant must have a negative pregnancy test
Must provide tissue samples for laboratory testing
Must be able to understand and follow study instructions
Must not have cancer that has spread to the brain or spinal cord
For previously treated patients: Must have had at least one prior treatment that included specific types of cancer medications

Who cannot join the trial?

16 criteria

Prior treatment with glofitamab or pirtobrutinib (these are the study medications)
Active or history of central nervous system (brain and spinal cord) lymphoma
Known allergic reactions or severe sensitivity to biological treatments
Significant heart problems, including:
- Heart failure requiring treatment
- Irregular heartbeat that is not well controlled
- Heart attack within the past 6 months
- Active or chronic infections, including:
  - Hepatitis B
  - Hepatitis C
  - HIV
  - Tuberculosis
  - Severe liver problems
  - Severe kidney problems requiring dialysis
  - Other types of cancer requiring treatment (except for successfully treated skin cancer or cervical cancer)
  - Pregnancy or breastfeeding
  - Unable to follow study procedures or attend scheduled visits
  - Participation in another clinical trial within the past 28 days

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Verified sites

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Region Midtjylland
Responsive
Aarhus, Denmark
Region Oestergoetland
Responsive
Linkoping, Sweden
Region Vaesterbotten
Responsive
Umea, Sweden

Trial locations

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Investigated drugs

Glofitamab
is a medication designed to target and fight specific types of blood cancer cells. It works by helping your immune system recognize and attack cancer cells, particularly in patients with mantle cell lymphoma.
Pirtobrutinib
is a medication that works by blocking specific proteins that help cancer cells grow and survive. It's used to treat various types of blood cancers, including mantle cell lymphoma.
Ibrutinib
is a medication that helps treat blood cancers by blocking certain proteins that cancer cells need to survive and multiply. It's used as a comparison treatment in this study.
Bendamustine
is a chemotherapy medication that works by damaging the DNA of cancer cells, which prevents them from growing and dividing.
Rituximab
is an antibody therapy that targets specific proteins on the surface of certain blood cancer cells, helping the immune system to identify and destroy these cells.

What is already known about the treatment

Glofitamab
A novel bispecific antibody administered through intravenous infusion, targeting both CD20 and CD3 proteins in the treatment of Mantle Cell Lymphoma (MCL). This medication works by bringing T-cells into close proximity with B-cells, enabling the immune system to attack cancer cells more effectively. Currently undergoing clinical trials, it belongs to the class of immunotherapy agents and shows promising results in treating relapsed/refractory MCL patients.
Pirtobrutinib
An oral medication belonging to the class of Bruton's tyrosine kinase (BTK) inhibitors, specifically designed for treating blood cancers including Mantle Cell Lymphoma (MCL). This next-generation BTK inhibitor works by blocking specific cellular signaling pathways that cancer cells need to survive and proliferate. Currently being studied in clinical trials, it shows potential benefits for both treatment-naive and previously treated MCL patients, particularly when combined with other therapeutic agents.

Investigated diseases

Mantle Cell Lymphoma (MCL) - A rare type of non-Hodgkin lymphoma that develops in the outer edge (mantle zone) of lymph nodes. It begins when B-cells, a type of white blood cell in the immune system, become abnormal and start growing uncontrollably. The disease typically affects lymph nodes, but can spread to other parts of the body including the bone marrow, liver, and digestive system. MCL usually progresses gradually and can affect people of any age, though it's more common in older adults. The condition causes symptoms such as enlarged lymph nodes, fatigue, and unexplained weight loss.