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

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Joseph Tuscano

Must be taking: Aspirin

Must not be taking: Efavirenz, Stavudine, Zidovudine

Disqualifiers: Active hepatitis B or C, Autoimmune disease, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 cycles (approximately 48 weeks)

8 Participants Needed

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.

Research Team

Joseph M. Tuscano

Principal Investigator

University of California, Davis

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

Patients must be willing to be followed at a minimum of approximately every 3 months by physician expert in HIV disease management

All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategies (REMS) program, and be willing and able to comply with the requirements of the REMS program

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

Exclusion Criteria

My lymphoma has spread to my brain or spinal cord.

I am not using any other cancer treatments.

I have hepatitis B or C but am on treatment with no liver damage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive azacitidine, obinutuzumab, and lenalidomide in cycles. Initial cycle lasts 35 days, followed by 28-day cycles for up to 12 cycles.

Up to 12 cycles (approximately 48 weeks)

Multiple visits per cycle for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• CC-486
• Lenalidomide
• Obinutuzumab

Trial Overview 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.

Participant Groups

Group I: Treatment (lenalidomide, oral azacitidine, obinutuzumab) Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

Joseph Tuscano

Lead Sponsor

Trials

8

Recruited

180+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Celgene

Industry Sponsor

Trials

649

Recruited

130,000+

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Jay Backstrom

Celgene

Chief Medical Officer since 2016

MD

Mark Alles

Celgene

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania