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

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What is this study about?

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.

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

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

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Rostock University Medical Center	Rostock	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Vaesterbotten	Umea	Sweden
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
St. Olavs Hospital HF	Trondheim	Norway
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Odense University Hospital	Odense	Denmark
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Karolinska University Hospital	Solna	Sweden
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Region Sjaelland	Holbæk	Denmark
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Ukgzdjaahrqdencdsjhru Etqvq Ahi	Essen	Germany
Hkypuuez Ulncsdolyxjwn De Lw Pbufsgwh	Madrid	Spain
Hyueozqp Ujlbffthnmlms Mjhhjxd Db Vjuovmmwwt	Santander	Spain
Uivfcuw Ucqhvcnqwa Hkdbjlxg	Uppsala	Sweden
Udpdabsfyahqfadmsvyeh Meyjrpus Aib	Munster	Germany
Ksfdryrx dhr Uncpciilihhf Mjryoudg Aem	Munich	Germany
Ikxvkmsw Cffnll Dgtljwwxcmnnylkwe	L'hospitalet De Llobregat	Spain
Usdkrrtxcy Mfcwpmt Cssyvh Hbvjspqjmfgqsvhma	Hamburg	Germany
Hynkhhvu Vkgy dyxkeksa	Barcelona	Spain
Ufmponohsxobtswclcenu Dzegeytxxzy Aio	Duesseldorf	Germany

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.06.2025
Germany	Recruiting	01.06.2025
Norway	Not yet recruiting	01.06.2025
Spain	Recruiting	01.06.2025
Sweden	Recruiting	01.06.2025

Trial locations

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.

Investigated diseases:

Mantle cell lymphoma

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.

Trial ID:

2024-512922-27-00

Protocol code:

PLATO

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?