In short
There is currently 1 ongoing clinical trial for Plasmablastic Lymphoma, a rare and aggressive type of non-Hodgkin lymphoma. This trial is investigating a combination treatment approach for patients whose disease has returned or has not responded to previous therapies.
Clinical trial locations
Study on the Effects and Safety of Daratumumab, Bortezomib, and Dexamethasone for Patients with Relapsed or Refractory Plasmablastic Lymphoma
This clinical trial is being conducted in Italy and focuses on patients whose disease has either returned after treatment or has not responded to initial therapies. The study tests a combination of three medications working together to control the disease.
Main inclusion criteria:
- Confirmed diagnosis with cancer cells showing a specific marker called CD38
- Age 18 years or older
- Disease that has returned or not responded after at least one round of standard chemotherapy
- Performance status of 3 or less on the ECOG scale, which measures ability to perform daily activities
- At least one measurable area of disease visible on imaging tests
- Both HIV-negative and HIV-positive patients can participate, provided HIV infection is controlled with treatment
- Agreement to use effective birth control methods during the study period
Main exclusion criteria:
- Patients eligible for stem cell transplantation using their own cells or donor cells
- Patients who have not experienced disease return after a previous stem cell transplantation
Focus and goal: The trial is designed to evaluate how well the three-medication combination works in controlling the disease. It follows a structured approach with two main phases. The induction phase begins with daratumumab given alone as a subcutaneous injection, followed by a combination of all three medications given in cycles. The response is evaluated after cycles 3, 6, and 9. The maintenance phase continues with daratumumab alone to maintain the achieved response, with evaluations after cycles 12 and 15. Throughout the study, researchers monitor how the cancer responds to treatment, how long patients remain free from disease progression, overall survival rates, and effects on the immune system.
Investigational drugs:
- Daratumumab – A monoclonal antibody that targets specific proteins on cancer cell surfaces, helping the immune system identify and destroy these cells. It is administered as an injection under the skin.
- Bortezomib – A proteasome inhibitor that interferes with cancer cell growth by blocking the breakdown of proteins inside cells, leading to cancer cell death. It is also given as an injection under the skin.
- Dexamethasone – A corticosteroid taken orally that reduces inflammation and suppresses immune response, helping to manage symptoms and enhance the effects of other cancer treatments.
Summary
Currently, there is one active clinical trial for Plasmablastic Lymphoma, located in Italy. This trial focuses specifically on patients with relapsed or refractory disease, offering a combination therapy approach using daratumumab, bortezomib, and dexamethasone. The study is particularly notable for its inclusion of both HIV-negative and HIV-positive patients, reflecting the disease's common occurrence in individuals with weakened immune systems. The trial uses a structured two-phase approach, starting with an induction phase to achieve initial response, followed by a maintenance phase to sustain treatment benefits. This research aims to provide valuable information about treating this rare and aggressive form of lymphoma when standard treatments have not been successful.
