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Anti-tumor antibiotic

Bendamustine + Venetoclax + Rituximab for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Led By Nicole Lamanna, MD

Research Sponsored by Nicole Lamanna

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Oncology Cooperative Group (ECOG) performance score of ≤ 2

Age ≥ 18 years of age

Must not have

Treatment with steroid therapy for anti-neoplastic intent, moderate or strong CYP3A inhibitors, or inducers within 7 days prior to the first dose of study drug

Received an allogeneic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Summary

This trial will test if the addition of venetoclax to bendamustine and rituximab can safely and effectively treat patients with relapsed or refractory CLL.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to immune system suppression such as infection risks; infusion-related reactions; blood electrolyte imbalances leading to kidney failure or other serious conditions due to tumor lysis syndrome; and general side effects like fatigue or digestive disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have received a stem cell transplant from a donor.

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I am currently being treated for an autoimmune disease.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate (ORR) after the completion of all therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

FDA approved

Bendamustine

FDA approved

Rituximab

FDA approved

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nicole LamannaLead Sponsor

Nicole Lamanna, MD5.013 ReviewsPrincipal Investigator - Columbia University

Columbia University

2 Previous Clinical Trials

219 Total Patients Enrolled

5Patient Review

I feel incredibly lucky to have been Dr. Lamanna's patient for the last 16 years. Not only is she caring, but she also stays current with all the latest breakthroughs and updates. I have complete confidence in her.