CC-486 + Lenalidomide + Obinutuzumab for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen ByJoseph M. Tuscano

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Joseph Tuscano

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I/Ib trial investigates the side effects of CC-486 and how well it works in combination with lenalidomide and obinutuzumab in treating patients with CD20 positive B-cell lymphoma that has come back (recurrent) or has not responded to treatment (refractory). Chemotherapy drugs, such as CC-486, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide is a drug that alters the immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Obinutuzumab is a type of antibody therapy that targets and attaches to the CD20 proteins found on follicular lymphoma cells as well as some healthy blood cells. Once attached to the CD20 protein the obinutuzumab is thought to work in different ways, including by helping the immune system destroy the cancer cells and by destroying the cancer cells directly. Giving CC-486 with lenalidomide and obinutuzumab may improve response rates, quality, and duration, and minimize adverse events in patients with B-cell lymphoma.

Eligibility Criteria

This trial is for patients with CD20 positive B-cell lymphoma that's returned or hasn't responded to treatment. Participants must have had prior treatments, be able to consent, follow the study schedule, and swallow pills. They should not have other serious medical conditions or be on conflicting medications.

Inclusion Criteria

I can take daily aspirin or a substitute if I'm allergic.

I am not taking HIV drugs that have similar side effects to the study drugs.

I can swallow pills.

I stopped all cancer treatments including radiation, hormonal therapy, and surgery at least 4 weeks ago.

I am mostly active and can carry out daily activities.

I have been treated for a type of lymphoma that tests positive for CD20.

Exclusion Criteria

My lymphoma has spread to my brain or spinal cord.

I am not using any other cancer treatments.

I have been treated for an autoimmune disease in the last 2 years.

I do not have any untreated severe infections.

I have previously used obinutuzumab or CC-486.

I haven't had serious heart problems like heart failure or a heart attack in the last 6 months.

I don't have any bowel or stomach conditions that could affect how a study drug works or cause more side effects.

Participant Groups

The trial tests CC-486 combined with lenalidomide and obinutuzumab for recurrent/refractory B-cell lymphoma. It explores how well this combination works and its safety profile in improving patient outcomes while minimizing side effects.

1Treatment groups

Experimental Treatment

Group I: Treatment (lenalidomide, oral azacitidine, obinutuzumab)Experimental Treatment3 Interventions

Patients receive azacitidine PO QD on days 1-21, obinutuzumab IV over on days 8, 15, 22, and 29, and lenalidomide PO QD on days 8-28 of cycle 1. Treatment continues for 35 days in the absence of disease progression or unacceptable toxicity. Patients then receive azacitidine PO QD on days 1-21, obinutuzumab IV over on day 1, and lenalidomide PO QD on days 1-21. Cycles repeats every 28 days in the absence of disease progression, unacceptable toxicity, or until stem cell transplant. Patients who achieve SD, PR, or CR do not proceed to stem cell transplant may continue treatment for up to 12 cycles in the absence of disease progression or unacceptable toxicity.