Angioimmunoblastic T-cell lymphoma refractory Trials in Disease

Study on the Effectiveness and Safety of Azacitidine, Gemcitabine, and Bendamustine Hydrochloride for Patients with Relapsed or Refractory Angioimmunoblastic T-cell Lymphoma

This clinical trial is examining treatment options for patients whose disease has either returned after previous treatment or has not responded to standard therapies. The study compares oral azacitidine, a medication taken by mouth, to other treatments chosen by doctors, such as gemcitabine and bendamustine hydrochloride, which are given through infusion directly into the bloodstream.

Main inclusion criteria:

• Patients must be 18 years or older
• Confirmed diagnosis of angioimmunoblastic T-cell lymphoma or related conditions with T-follicular helper cell characteristics, verified by biopsy showing specific markers (CD10, CXCL13, PD1, ICOS, or BCL6)
• Disease must have relapsed or not responded to at least one previous line of systemic therapy
• At least one measurable tumor lesion (larger than 1.5 cm for lymph nodes or 1.0 cm for lesions outside lymph nodes)
• Adequate blood counts, including neutrophils at least 1.5 x 10⁹/L (or 1 x 10⁹/L if bone marrow is affected), platelets at least 75 x 10⁹/L (or 50 x 10⁹/L if bone marrow is affected), and hemoglobin at least 8 g/dL
• Performance status of 0 to 3 on the ECOG scale, which measures how the disease affects daily activities
• Life expectancy of at least 3 months
• Women of childbearing potential must have negative pregnancy tests and agree to use effective birth control during the study and for 6 months afterward
• Male patients must also agree to use birth control during the study and for 6 months afterward

Main exclusion criteria:

• Patients with other types of cancer not related to this specific lymphoma
• Previous cancer that was not successfully treated or has returned recently
• Uncontrolled serious infections
• Pregnancy or breastfeeding
• Known allergies to the study medications or their ingredients
• Medical conditions that would make participation unsafe according to study doctors
• Current participation in another clinical trial
• Recent major surgery
• History of certain heart or lung conditions
• Patients with only skin involvement are excluded

Focus and goals: The primary goal of this trial is to determine how well patients do without their disease getting worse when treated with oral azacitidine compared to other therapies. The study will also monitor overall survival, quality of life, and the safety of the treatments. Patients will be randomly assigned to receive either oral azacitidine or another treatment selected by their doctor. Throughout the trial, participants will undergo regular assessments including blood tests and imaging studies to monitor disease response and any side effects. After treatment ends, patients will enter a follow-up period with periodic check-ins to monitor long-term outcomes.

Investigational drugs: The main medication being tested is oral azacitidine (CC-486), taken as a tablet by mouth. This is a chemotherapy drug that works by interfering with DNA in cancer cells, which can stop them from growing and dividing. The study also involves comparison to other treatments including gemcitabine and bendamustine hydrochloride, both of which are administered through infusion.