Study to Evaluate the Association Between Lenalidomide and Tumor Flare Reactions and High Tumor Burden in Patients with Relapsed or Refractory Mantle Cell Lymphoma
- Gender
- Women and men
- Age
- 18 years and older
- Trial type
- Observational
- Line of therapy
- Relapsed / refractory
- Phase
- —
What is this trial about?
Mantle cell lymphoma is a type of lymphoma that can vary greatly in its response to treatment. Lenalidomide can be used to treat relapses or patients who did not respond to initial treatment (refractory). The goal of the study is to investigate and characterize the relationship between lenalidomide and the so-called tumor flare reaction as well as tumor burden in people with relapsed/refractory mantle cell lymphoma. No drug or therapy is being tested in this study. Patients who have received at least one dose of lenalidomide and are at least 18 years old are eligible to participate in the study.
Detailed description
Mantle cell lymphoma (MCL) is a rare form of lymphoma in which certain white blood cells—B cells—undergo malignant changes. In most cases, the disease progresses slowly; however, some patients have an aggressive subtype that requires more intensive treatment. Standard treatments include chemotherapy, immunotherapy, and stem cell transplantation, but in some patients, the disease returns after treatment or no longer responds to it. Lenalidomide, also known by the brand name Revlimid, is a medication that supports the immune system and inhibits the growth of cancer cells. It is commonly used today in the treatment of recurrent or treatment-refractory cases of MCL. This study investigates the relationship between lenalidomide and the so-called tumor flare reaction (TFR) and overall tumor burden in patients with relapsed or refractory MCL. A tumor flare reaction is a temporary worsening of tumor-related symptoms after the start of treatment, which can sometimes be difficult to distinguish from disease progression. Tumor burden refers to the number of cancer cells in the body. The study design is non-interventional and retrospective, meaning that existing data from patients who have received lenalidomide will be analyzed. No new drug or treatment will be tested in the study; it is purely observational. Data are being collected from various European clinics that have used lenalidomide in MCL patients to investigate the frequency and characteristics of TFR and tumor burden. Eligible participants are adults who have received at least one dose of lenalidomide as part of their MCL treatment.
Facts
- Disease: Mantle cell lymphoma (MCL).
- Cancer characteristics: Relapsed or refractory (unresponsive to treatment).
- What the study investigates: The relationship between lenalidomide and tumor flare reaction (TFR) and tumor burden. No medication or new form of therapy is being tested.
- Study objective: To investigate tumor flare reaction and tumor burden in MCL.
- Study duration: Observation period up to approximately 8.5 years ago.
- Study characteristics: Retrospective, non-interventional—i.e., a purely observational study
Trial sites
3 trial sites in Germany are listed.
Berufsausuebungsgemeinschaft Kiehl/Stein
15236 Frankfurt/ Oder Brandenburg
Status unknownPraxis fuer Haematolgie, Onkologie und Palliativmedizin
04289 Leipzig
Status unknownUniversitätsklinikum Würzburg
97080 Würzburg
Status unknown
This list is compiled to the best of our knowledge but without guarantee: it may be incomplete, and a site's recruitment status can change at any time.
- Dr. med. Sebastian SommerSpecialist in internal medicine with a focus on hematology and oncology
- PD Dr. med. Matthias FröhlichSpecialist in internal medicine, immunology and emergency medicine
This description is based on the public trial registry (NCT03647124) and was translated into plain language by our medical editorial team. Whether participation is an option for you is a decision you make together with your treating physician.


