A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

Launched by ASTRAZENECA · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with untreated follicular lymphoma, a type of cancer that affects the lymphatic system. The research is comparing a combination of two medications, AZD0486 and rituximab, to standard treatment options that doctors usually prescribe for this condition. The goal is to find out if this new combination is more effective and safe for patients.

To be eligible for this trial, participants need to be at least 18 years old and have a confirmed diagnosis of follicular lymphoma that meets certain criteria. They should not have received any previous treatment for their lymphoma and must have measurable disease that requires treatment. Participants can expect to receive close monitoring throughout the trial, and they will be randomly assigned to either the new treatment or a standard treatment chosen by their doctor. It’s important to know that not everyone will qualify for the study, especially those with more aggressive forms of lymphoma or certain health issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
• • 2. Histologically confirmed diagnosis of FL Grades 1-3A per WHO 2016 classification
• • 3. ECOG performance status of 0 to 2
• • 4. No prior systemic lymphoma-directed therapy
• • 5. Need for systemic treatment meeting at least 1 GELF criteria
• • 6. FDG-avid and measurable disease
• • 7. Adequate liver, hematological, renal and cardiac function.
• • The above is a summary, other inclusion criteria details may apply
• Exclusion Criteria:
• • 1. Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
• • 2. Contra-indication to BR, RCVP, and R-CHOP
• • 3. Participants with or history of CNS lymphoma
• • 4. Presence of \>5000 circulating lymphoma cells
• • 5. Active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study
• • The above is a summary, other exclusion criteria details may apply