Ongoing Clinical Trials for Mantle Cell Lymphoma Stage II
There are currently 2 clinical trials investigating new treatment approaches for mantle cell lymphoma stage II. These studies are exploring innovative therapies including CAR-T-cell treatment and combinations of targeted medications to improve outcomes for patients with this rare form of non-Hodgkin’s lymphoma.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- Finland
- France
- Germany
- Italy
- Netherlands
- Norway
- Poland
- Portugal
- Spain
- Sweden
Study on CAR-T-cell Therapy with Rituximab and Ibrutinib for Patients with High-Risk Mantle Cell Lymphoma
This trial is exploring an innovative treatment approach for patients with high-risk mantle cell lymphoma who have not yet received treatment. The study compares an experimental CAR-T-cell therapy strategy with standard treatment methods.
Main inclusion criteria:
- Confirmed diagnosis of mantle cell lymphoma with specific markers such as overexpression of cyclin D1 or the genetic change t(11;14)
- Age between 18 and 75 years
- At least one measurable tumor or lesion
- Stage II-IV disease according to the Ann Arbor staging system
- At least one high-risk feature, such as a high score on the MIPI-c risk index or a TP53 genetic mutation
- No prior treatment for the condition
- ECOG performance status of 2 or less, meaning patients can perform self-care activities
- Specific laboratory values within acceptable ranges for white blood cells, platelets, kidney function, and liver function
- No evidence of disease in the central nervous system
- Ability to reach the study site within 2 hours in case of emergency
Main exclusion criteria:
- Previous treatment for mantle cell lymphoma
- Not meeting the high-risk criteria
- Outside the specified age range
- Belonging to a vulnerable population group
- Not meeting other specific health criteria required for safety
Treatment approach:
The study divides participants into two groups. The experimental group receives a shortened induction therapy with Rituximab and Ibrutinib, followed by CAR-T-cell therapy using KTE-X19 (also known as brexucabtagene autoleucel or Tecartus). This involves collecting and modifying the patient’s own immune cells to better target cancer cells. After the CAR-T-cell treatment, patients continue with Ibrutinib maintenance therapy for 6 months. The control group receives standard treatment, which may include combinations of chemotherapy medications administered according to current best practices.
Investigational drugs:
- Rituximab: A medication that targets specific proteins on cancer cells, helping the immune system destroy them. It is given through intravenous infusion
- Ibrutinib: An oral medication that slows or stops cancer cell growth by interfering with pathways cancer cells use to survive. It is given during both treatment and maintenance phases
- KTE-X19: A CAR-T-cell therapy that modifies patients’ own immune cells to recognize and attack cancer cells more effectively. It is administered through intravenous infusion
The study aims to evaluate whether this CAR-T-cell therapy approach can improve outcomes compared to standard care, measuring factors such as failure-free survival, progression-free survival, and overall response rates.
Study on Ibrutinib and Drug Combination for Patients with Generalized Mantle Cell Lymphoma
This trial is investigating different treatment strategies for patients with generalized mantle cell lymphoma, comparing the addition of Ibrutinib to standard chemotherapy regimens and evaluating whether stem cell transplantation can be omitted in certain treatment approaches.
Main inclusion criteria:
- Confirmed diagnosis of mantle cell lymphoma according to WHO classification
- Age between 18 and 65 years
- No previous treatment for the condition
- Stage II-IV disease according to the Ann Arbor staging system
- At least one measurable tumor
- Suitable for high-dose treatment, including high-dose Ara-C chemotherapy
- ECOG/WHO performance status of 2 or less
- Adequate laboratory values for neutrophils (at least 1000 cells), platelets (at least 100,000 cells), liver enzymes (no more than 3 times the upper limit), bilirubin (no more than 2 times the upper limit), and kidney function (creatinine clearance at least 50 mL/min)
- Men and women of childbearing potential must agree to use highly effective birth control methods during the study and for a specified period afterward
Main exclusion criteria:
- Any other type of cancer besides generalized mantle cell lymphoma
- Previous different cancer within the last 5 years, unless fully treated and in remission
- Serious heart problems or uncontrolled infections
- Pregnancy or breastfeeding
- Major surgery within the last 4 weeks
- Current participation in another clinical trial
- Known allergies to the study drugs
- Severe liver or kidney disease
- History of drug or alcohol abuse
Treatment approach:
Participants are randomly assigned to one of three treatment groups. The control group receives standard R-CHOP chemotherapy followed by R-DHAP and autologous stem cell transplantation (ASCT). The first experimental group receives R-CHOP combined with Ibrutinib, followed by R-DHAP, stem cell transplantation, and Ibrutinib maintenance therapy. The second experimental group receives R-CHOP with Ibrutinib followed by R-DHAP and Ibrutinib maintenance therapy, but without stem cell transplantation. This design allows researchers to evaluate whether adding Ibrutinib improves outcomes and whether stem cell transplantation is necessary when using Ibrutinib.
Investigational drugs and procedures:
- Rituximab: Targets specific immune system cells involved in cancer growth, administered intravenously
- Ibrutinib: An oral medication that blocks signals cancer cells need to grow and divide
- Ara-C (cytarabine): A chemotherapy drug that interferes with cancer cell DNA to prevent their growth
- R-CHOP: A combination of several chemotherapy drugs that attack cancer cells in different ways
- R-DHAP: Another combination of chemotherapy medications used to target cancer cells through multiple mechanisms
- ASCT (autologous stem cell transplantation): A procedure where healthy stem cells are collected from the patient and used to replace damaged bone marrow after intensive chemotherapy
The study monitors participants through regular assessments to evaluate treatment response, measuring failure-free survival, progression-free survival, and overall survival while tracking any side effects.
Summary
Both clinical trials for mantle cell lymphoma stage II are investigating ways to improve treatment outcomes for patients who have not yet received therapy. A notable pattern is the focus on Ibrutinib, a targeted medication that appears in both studies, highlighting its importance in modern treatment approaches for this condition.
The trials show significant geographical diversity, with the second study being conducted across 12 European countries (Germany, Italy, Poland, Denmark, Sweden, Netherlands, Norway, Belgium, Finland, Portugal, Spain, and Czechia), while the first trial operates in 5 countries (Germany, France, Spain, Netherlands, and Czechia). This wide distribution provides opportunities for patients across Europe to access innovative treatments.
The studies represent two different innovative approaches: one exploring the potential of CAR-T-cell therapy combined with targeted medications, and another comparing different chemotherapy combinations with and without stem cell transplantation. Both trials are designed for patients aged 18-65 or 18-75 years with stage II-IV disease who have not previously received treatment.
These studies reflect ongoing efforts to personalize treatment approaches and potentially reduce treatment intensity while maintaining or improving effectiveness. Patients interested in participating should discuss eligibility with their healthcare team, as both trials have specific medical requirements for participation.
