← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am 18 years old or older.

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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 / 4Eligibility 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.

Media Library

Bendamustine (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03609593 — Phase 2

Chronic Lymphocytic Leukemia Research Study Groups: BR followed by venetoclax and rituximab

Chronic Lymphocytic Leukemia Clinical Trial 2023: Bendamustine Highlights & Side Effects. Trial Name: NCT03609593 — Phase 2

Bendamustine (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03609593 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What deleterious effects is Bendamustine known to have on individuals?

"Taking into account the Phase 2 trial status of Bendamustine, our team at Power believes it is suitable to assign a score of two in regards to its safety. There is evidence regarding Bendamustine's security but no concrete data yet that affirms efficacy."

Answered by AI

Is participation in this trial available to individuals aged 65 and over?

"The entry requirements for this medical trial set the lower age limit at 18 and cap it off with a maximum of 99 years."

Answered by AI

Has Bendamustine been evaluated in any past research endeavors?

"At the present moment, there are 630 active clinical studies researching Bendamustine with 118 of them currently in Phase 3. Edmonton, Alberta is one of many locales conducting trials for this drug, and across 21179 locations research is ongoing."

Answered by AI

Is enrollment currently available for this experimental program?

"Affirmative. Based on the information provided by clinicaltrials.gov, this research endeavour is actively seeking out participants for its trial which was first posted in November 2018 and last amended in August 2022. This study requires 45 individuals to be recruited from two medical sites."

Answered by AI

What are the typical conditions that Bendamustine is prescribed to address?

"Bendamustine is primarily employed to treat diffuse large b-cell lymphoma, yet it also has efficacy managing Hodgkin's disease and other B cell lymphomas as well as polyangium."

Answered by AI

Could I be accepted as a participant in this clinical research?

"To be eligible, patients must have leukemia or lymphoid malignancies and they should fall between the ages of 18-99. The clinical trial is searching for a total of 45 participants to join."

Answered by AI

How many participants are involved in this medical research?

"Affirmative. On clinicaltrials.gov, there is evidence that this medical trial went live on November 12th 2018 and the most recently revised information was put up on August 10th 2022. 45 entrants need to be enrolled at 2 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia

Nicole Lamanna 2018. "Bendamustine/Rituximab Followed by Venetoclax and Rituximab for Treatment of Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03609593.

All > Cll > Chronic Lymphocytic Leukemia