Combination Immunotherapy + Chemotherapy for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByLiana Nikolaenko

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a combination of immune-boosting proteins, a growth-blocking drug, and chemotherapy in patients with certain types of lymphoma that have returned or are resistant to standard treatments. The treatment aims to attack the cancer in multiple ways by boosting the immune system, blocking cancer growth, and killing cancer cells.

Eligibility Criteria

This trial is for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or mantle cell lymphoma (MCL). They must have a life expectancy over 3 months, be in fairly good health (ECOG score of 0-2), and have adequate organ function. Women should not be pregnant and both genders must agree to use contraception. Exclusions include prior treatments with certain drugs, active infections, other cancers within the last 3 years, severe heart conditions, CNS disease history, and autoimmune diseases.

Participant Groups

The trial tests the combination of monoclonal antibodies avelumab, utomilumab, rituximab with chemotherapy agents ifosfamide, carboplatin etoposide phosphate plus Ibrutinib in patients who've had their lymphoma return or resist treatment. It aims to find safe dosages and observe how well these drugs work together against these types of cancer.

2Treatment groups

Experimental Treatment

Group I: Cohort II (avelumab, utomilumab, rituximab, ibrutinib)Experimental Treatment5 Interventions

Patients receive rituximab IV on day 1, avelumab IV over 60 minutes on days 2 and 16, and ibrutinib PO QD or rituximab IV on day 1, avelumab IV over 60 minutes on days 2 and 16, utomilumab IV on day 2, and ibrutinib PO QD. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. (Closed as of 12/12/2019)

Group II: Cohort I (avelumab, utomilumab, RICE)Experimental Treatment8 Interventions

Patients receive rituximab IV on day 1, etoposide phosphate IV on days 1-3, avelumab IV over 60 minutes on day 2, ifosfamide IV over 24 hours on day 2, and carboplatin IV on day 2 or rituximab IV on day 1, etoposide phosphate IV on days 1-3, avelumab IV over 60 minutes on days 2, utomilumab IV over 60 minutes on day 2, ifosfamide IV over 24 hours on day 2, and carboplatin IV on day 2. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients may then undergo autologous hematopoietic stem cell transplantation.

Avelumab is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Bavencio for: