About this trial
Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.
The goals of this study are to learn:
* About the safety of MK-1045 and rituximab, and if people tolerate them when given together * If people who receive MK-1045 and rituximab have the cancer go away * If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)
Eligibility criteria
Qualifiers
Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.
Has radiographically measurable disease per the Lugano Response Criteria.
Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.
If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).
Disqualifiers
Has received prior systemic anticancer therapy or radiotherapy for FL.
Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.
Has FL that has transformed into a more aggressive type of lymphoma.
History or presence of clinically relevant central nervous system (CNS) diseases.
Trial design
Treatments tested in this trial
- MK-1045
- Rituximab
- Rituximab biosimilar
- Bendamustine
- Cyclophosphamide
- Vincristine
- Prednisone
- Prednisolone
- Doxorubicin Hydrochloride