Ongoing Clinical Trials for Adult T-cell Lymphoma/Leukaemia Refractory
There are currently 2 ongoing clinical trials for patients with adult T-cell lymphoma/leukaemia that has not responded to previous treatments or has returned after treatment. These studies are testing different combinations of medications to find better treatment options for this challenging condition.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- France
- Germany
- Italy
- Netherlands
- Poland
- Spain
Study Comparing Duvelisib with Gemcitabine or Bendamustine for Patients with Relapsed or Resistant T Cell Lymphoma Originating from T Follicular Helper Cells
This trial is comparing different treatment approaches for patients with a specific type of T-cell lymphoma that originates from T follicular helper cells. The study is testing whether a medication called Duvelisib works better than two commonly used chemotherapy drugs, Gemcitabine or Bendamustine.
Who can participate:
- Patients must have a confirmed diagnosis of nodal T-cell lymphoma with T follicular helper cell features, including types such as Angioimmunoblastic T-cell lymphoma and follicular T-cell lymphoma
- The disease must have returned after treatment or not responded to at least one previous therapy
- Patients must have measurable disease that can be tracked through medical imaging
- Participants should have an ECOG Performance Status of 0, 1, or 2, meaning they can perform daily activities with varying levels of ability
- Both male and female patients can participate
Who cannot participate:
- Patients whose disease has not relapsed or worsened
- Patients outside the specified age range for the study
- Patients who do not meet the clinical trial group requirements
What the trial involves:
The main goal of this study is to see how long patients can live without their disease getting worse. Participants will be randomly assigned to receive either Duvelisib as oral capsules taken twice daily, or intravenous infusions of either Gemcitabine or Bendamustine as chosen by their doctor. The study will follow participants for up to three years, monitoring disease progression, overall survival, quality of life, and any side effects experienced.
Investigational drugs:
Duvelisib is an oral medication that works by blocking certain proteins that help cancer cells grow and survive. It is a PI3K inhibitor, meaning it targets a specific pathway that cancer cells use to thrive. Gemcitabine is a chemotherapy drug given through a vein that interferes with cancer cell DNA, preventing them from growing and dividing. Bendamustine is also given intravenously and damages cancer cell DNA, stopping them from multiplying and leading to their death.
Study of Selinexor, Ifosfamide, Etoposide, and Dexamethasone for Patients with Relapsed or Refractory Peripheral T-cell Lymphomas
This trial is testing a combination of four medications to treat patients with peripheral T-cell lymphoma that has either returned after treatment or has not responded to previous therapies. The study aims to find out how effective this combination treatment is and how well patients tolerate it.
Who can participate:
- Patients must have a confirmed diagnosis of specific types of T-cell lymphomas as defined by the World Health Organization classification
- Age must be between 18 and 75 years
- The disease must have relapsed or not responded to at least one previous treatment that included anthracycline chemotherapy
- Patients must have measurable disease that can be detected by imaging tests like CT or MRI
- Performance status should be 2 or less, meaning patients can care for themselves but may have limited ability to work
- Life expectancy should be at least 3 months
- Organs must function normally, with specific requirements for kidney, heart, and liver function
- Female and male patients of reproductive age must use effective birth control during the study and for 90 days after
- Tissue samples from the tumor must be available
Who cannot participate:
- Patients whose disease has not relapsed or worsened
- Patients who cannot safely take the study medications
- Pregnant or breastfeeding women
- Patients with serious health conditions that could interfere with the study
- Patients currently participating in another clinical trial
- Patients with central nervous system involvement or a history of psychiatric disease
What the trial involves:
The study aims to determine the overall response rate, which includes both complete and partial responses to treatment. Participants will receive a combination of four medications: Selinexor taken orally as tablets, and Ifosfamide, Etoposide, and Dexamethasone given as infusions or injections. Treatment is given in cycles, and after four cycles, doctors will evaluate how well the treatment is working. The study will also monitor long-term outcomes such as progression-free survival and overall survival, along with any side effects.
Investigational drugs:
Selinexor is an oral medication that blocks certain proteins in cancer cells, potentially leading to their death. It is a selective inhibitor of nuclear export, targeting specific pathways in cancer cells. Ifosfamide is a chemotherapy drug given intravenously that interferes with cancer cell DNA, preventing them from multiplying. It belongs to a class called alkylating agents. Etoposide is administered by infusion and stops cancer cell growth by inhibiting enzymes essential for DNA replication. It is classified as a topoisomerase inhibitor. Dexamethasone is a steroid given by infusion or orally that helps reduce inflammation and suppress the immune system, often used to manage side effects and improve treatment effectiveness.
Summary
There are currently two ongoing clinical trials for patients with adult T-cell lymphoma/leukaemia that has not responded to treatment or has returned after therapy. One trial is being conducted across multiple European countries including Germany, Poland, France, Belgium, Netherlands, Denmark, Spain, Italy, and Czechia, while the other is taking place exclusively in Italy.
The first study compares a newer oral medication, Duvelisib, with established chemotherapy drugs Gemcitabine and Bendamustine. This trial offers the convenience of oral medication for one treatment group while the comparison group receives traditional intravenous chemotherapy. The second trial tests a four-drug combination including Selinexor, Ifosfamide, Etoposide, and Dexamethasone, focusing on patients with peripheral T-cell lymphomas.
Both studies accept patients whose disease has relapsed or not responded to previous treatment, though they have different age ranges and specific requirements. The trials aim to provide valuable information about treatment effectiveness, quality of life, and safety to help improve future care options for patients with these challenging conditions.
