MK-1045 and Rituximab in Follicular Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial examines the safety and effectiveness of combining MK-1045 with rituximab in adults with CD19+/CD20+ follicular lymphoma. The study includes phases 2 and 3 to assess tolerability, response rates, and progression-free survival compared with standard rituximab-based therapy. Participants have measurable disease, specific FL risk factors, and meet criteria related to HIV, HBV, and HCV status. Interventions may include rituximab alone, rituximab with MK-1045, or other components such as bendamustine and cyclophosphamide as part of standard regimens. Primary interests are safety, tumor response, and whether the combination improves outcomes over conventional treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).
* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.
* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.

Exclusion Criteria:

* 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.
* Has history of serious cardiovascular and cerebrovascular diseases.
* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Has known active CNS lymphoma or involvement.
* Has an active autoimmune disease that has required systemic treatment in the past 2 years.
* Has active infection requiring systemic therapy.
* Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.
* Has not adequately recovered from major surgery or has ongoing surgical complications.

Where it's running

• City of Hope - Duarte Cancer Center ( Site 1301)
  Duarte, California, United States Recruiting
• University of Kentucky ( Site 1303)
  Lexington, Kentucky, United States Recruiting
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 1311)
  Hackensack, New Jersey, United States Recruiting
• Icahn School of Medicine at Mount Sinai ( Site 1325)
  New York, New York, United States Recruiting
• Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307)
  Durham, North Carolina, United States Recruiting
• University Hospitals of Cleveland ( Site 1321)
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.