Bendamustine + Venetoclax + Rituximab for Chronic Lymphocytic Leukemia

Palo Alto (17 mi)

Dr. Nicole Lamanna - Medical Oncology ...

Overseen byNicole Lamanna, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Nicole Lamanna

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to determine the efficacy of bendamustine and rituximab (BR) followed by venetoclax for 12 months. The total time on therapy is 15 months. Bendamustine and rituximab is a commonly used treatment for CLL. Venetoclax is an oral drug that blocks a protein called BCL-2 which is present on CLL cells. It is approved for patients with relapsed (the cancer has come back) or refractory (the cancer did not respond) CLL who harbor a deletion in the short arm of chromosome 17 \[del(17p)\]. When this drug is used by itself, many patients needed to be admitted to the hospital to monitor for a complication known as tumor lysis syndrome. This is an oncologic emergency that is caused by massive destruction of tumor cells with the release of large amounts of electrolytes and other molecules into the blood that can lead to renal failure and potentially death.

Eligibility Criteria

Adults diagnosed with Chronic Lymphocytic Leukemia (CLL) who have not had prior treatment for their condition, except corticosteroids for symptom relief. Participants must be over 18, able to use contraception, and have adequate organ function. Excluded are those with allergies to trial drugs, active non-CLL cancers within the last 2 years (with some exceptions), significant health issues as assessed by the investigator, or current severe infections.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

I am 18 years old or older.

I have not received any treatment for CLL, except possibly corticosteroids for other conditions.

I have been diagnosed with chronic lymphocytic leukemia (CLL).

Exclusion Criteria

I haven't taken steroids or certain strong medications for cancer within the last week.

I have received a stem cell transplant from a donor.

I am currently being treated for an autoimmune disease.

I do not have an active infection, hepatitis B or C, HIV, or serious heart issues.

Treatment Details

The study is testing a combination of treatments: initially Bendamustine and Rituximab (BR) followed by Venetoclax plus Rituximab for CLL. The total therapy duration is 15 months. Venetoclax targets a protein on CLL cells but requires hospital monitoring due to risk of tumor lysis syndrome—a potentially fatal complication from rapid cancer cell breakdown.

1Treatment groups

Experimental Treatment

Group I: BR followed by venetoclax and rituximabExperimental Treatment3 Interventions

Subjects will be on Bendamustine 50-90 mg/m2 on days 1-2 for three cycles with each cycle being 28 days, and Rituximab 375 mg/m2 on day 1 or days 1-2 for three cycles with each cycle being 28 days. Venetoclax will then be started in a step-wise fashion per the package insert.

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

🇺🇸 Approved in United States as Treanda for: