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BCL-2 Inhibitor

Venetoclax + Rituximab for Mantle Cell Lymphoma

Phase 2

Recruiting

Led By Lode Swinnen, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

Age ≥ 60

Female subjects not surgically sterile or postmenopausal and non-vasectomized male subjects must practice at least 1 specified method of birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 240 days

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat mantle cell lymphoma in patients over 60 who have not been treated before. The goal is to see if this new combination of drugs is effective in treating this form of cancer without the use of chemotherapy.

Who is the study for?

This trial is for people over 60 with a new diagnosis of mantle cell lymphoma who need treatment but haven't had any yet. They should be in fairly good health, able to perform daily activities, and have decent blood counts and organ function. Pregnant or breastfeeding women can't join, nor can those with certain types of the disease, uncontrolled infections, HIV, hepatitis B or C.Check my eligibility

What is being tested?

The study tests Venetoclax tablets combined with Rituximab injections as an initial therapy for older patients with mantle cell lymphoma. It's an open-label phase II trial aiming to see if this drug combo works well without chemotherapy by measuring overall response rates using PET/CT scans.See study design

What are the potential side effects?

Venetoclax and Rituximab may cause side effects like low blood cell counts leading to increased infection risk or bleeding problems, fatigue, nausea, diarrhea. There might also be allergic reactions related to the infusion of Rituximab.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 years old or older.

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I am using birth control as required.

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My diagnosis is mantle cell lymphoma, confirmed by a biopsy.

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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 240 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~240 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 240 days 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 four cycles of venetoclax and rituximab.

Secondary outcome measures

Proportion of CR

Proportion of PR

Proportion of disease progression

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: venetoclax and rituximab in patients over 60 yrs old with previously untreated mantle cell lymphomaExperimental Treatment1 Intervention

Venetoclax dose escalation for Cycles 1-4. If Complete response (CR) at Cycle 4, continue with cycles 5-12 at fixed venetoclax 400mg dose. If partial response (PR) at Cycle 4, continue with cycles 5-8 at fixed venetoclax 800mg dose. If CR at Cycle 8 after PR, continue with cycles 9-12 at fixed venetoclax 800mg dose. If continued PR at Cycle 8, reduce venetoclax to 400mg and add bendamustine 90 mg/m2.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,880 Total Patients Enrolled

AbbVieIndustry Sponsor

958 Previous Clinical Trials

502,350 Total Patients Enrolled

Lode Swinnen, MDPrincipal InvestigatorJohns Hopkins School of Medicine

2 Previous Clinical Trials

31 Total Patients Enrolled

Media Library

Venetoclax (BCL-2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05025423 — Phase 2

Mantle Cell Lymphoma Research Study Groups: venetoclax and rituximab in patients over 60 yrs old with previously untreated mantle cell lymphoma

Mantle Cell Lymphoma Clinical Trial 2023: Venetoclax Highlights & Side Effects. Trial Name: NCT05025423 — Phase 2

Venetoclax (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05025423 — Phase 2

Frequently Asked Questions

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

What maladies has Venetoclax Oral Tablet [Venclexta] been clinically demonstrated to address?

"Primarily, Venetoclax Oral Tablet [Venclexta] is employed to combat diffuse large b-cell lymphoma (dlbcl). However, it may also prove effective for hodgkin disease, b-cell lymphomas, and polyangium."

Answered by AI

How many individuals are being accepted for participation in this clinical research?

"Affirmative. Clinicaltrials.gov hosts data that confirms this research study, which initially went up on June 21st 2022, is presently recruiting patients. Around 40 participants are required from a single centre of care."

Answered by AI

Has the FDA authorized Venetoclax Oral Tablet [Venclexta] for commercial use?

"According to our team's assessment, the safety of Venclexta Oral Tablet is estimated at a 2 since this medication has yet to complete Phase 3 trials and relies on preliminary data for evidence of its efficacy."

Answered by AI

Are there any preceding research endeavors centering around Venetoclax Oral Tablet [Venclexta]?

"Currently, 630 trials are being conducted on Venetoclax Oral Tablet [Venclexta]. 118 of these studies are in the third stage. While Edmonton, Alberta is where most clinical tests take place for this medication, a total of 21179 sites have been utilized to study its efficacy."

Answered by AI

Are participants being conscripted for this experiment currently?

"Affirmative. According to info on clinicaltrials.gov, this medical trial is actively enlisting participants and was initially posted on June 21st 2022. As of now, 40 individuals need to be recruited from 1 site prior to the 29th of June 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma

2022. "Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05025423.

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