Ibrutinib + Venetoclax for Mantle Cell Lymphoma

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Pharmacyclics LLC.

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing whether a combination of two drugs, ibrutinib and venetoclax, is more effective than just using ibrutinib in patients with Mantle Cell Lymphoma (MCL). Ibrutinib works by stopping cancer cells from growing, while venetoclax helps to kill them. The goal is to see if this combination can better treat MCL. Ibrutinib and venetoclax have shown promising results in treating relapsed or refractory Mantle Cell Lymphoma (MCL) and are being tested together for their potential synergistic effects.

Eligibility Criteria

This trial is for adults with Mantle Cell Lymphoma who've had 1-5 prior treatments but haven't responded well. They must have a confirmed diagnosis, measurable disease on scans, and good organ function. Excluded are those with allergies to study drugs, recent heart attacks or strokes, active infections like HIV/HCV/HBV, severe liver issues, or gastrointestinal problems that affect drug absorption.

Inclusion Criteria

My cancer is confirmed as MCL with specific markers or genetic evidence.

I have had between 1 and 5 treatments for mantle cell lymphoma.

My last cancer treatment did not work or my cancer got worse after it.

I have a recent or preserved tissue sample available.

I am able to get out of my bed or chair and move around.

Exclusion Criteria

I have a history of HIV or active hepatitis B or C.

I have or had lymphoma in my brain or spinal cord.

I have not had major surgery in the last 4 weeks.

I cannot take pills due to issues with my digestive system.

I am not in another treatment study and have not taken ibrutinib or similar drugs.

I am not in another drug study and haven't taken ibrutinib or similar drugs.

I do not have any ongoing infections that aren’t being treated.

I have a known bleeding disorder like von Willebrand's or hemophilia.

I am willing and able to follow all study requirements.

My condition is a specific type of mantle cell lymphoma.

I finished IV treatment for a serious infection less than 14 days ago.

I have been treated with venetoclax or similar medications before.

I am 18 or older and have a TP53 mutation.

I have not had a heart attack or unstable heart conditions in the last 6 months.

My liver disease is moderate to severe.

Treatment Details

The SYMPATICO study tests the effectiveness of combining Ibrutinib (a known cancer drug) with Venetoclax versus Ibrutinib with a placebo in treating Mantle Cell Lymphoma. Participants will be randomly assigned to one of these two groups without knowing which one they're in.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment-naiveExperimental Treatment2 Interventions

This open-label arm is designed to explore the efficacy and safety of the combination of ibrutinib and venetoclax in subjects with treatment-naive MCL. Approximately 75 subjects (of which \~25 subjects with TP53 mutation) will be enrolled and treated with ibrutinib and venetoclax.

Group II: Safety Run-in PeriodExperimental Treatment2 Interventions

Subjects are enrolled into the open-label Safety Run-in Period to evaluate the occurrence of tumor lysis syndrome (TLS) and DLTs with the concurrent administration of ibrutinib and venetoclax. Safety run-in phase for the study is closed to further enrollment as of 07-Nov-2018.

Group III: Phase 3: Ibrutinb + VenetoclaxExperimental Treatment2 Interventions

Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity

Group IV: Phase 3: Ibrutinib + PlaceboPlacebo Group2 Interventions

Subjects will be randomized to receive ibrutinib and venetoclax/placebo until clinical disease progression or unacceptable toxicity

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

🇪🇺 Approved in European Union as Imbruvica for: