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Bcl-2 Inhibitor

Bcl-2 Inhibitor GDC-0199 for Chronic Lymphocytic Leukemia

Phase 1 & 2
Waitlist Available
Led By Kerry Rogers, MD
Research Sponsored by Kerry Rogers
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Treatment-naïve CLL patients in Phase II must meet specific requirements including symptomatic disease, no prior chemotherapy, and specified laboratory values
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing a combination of drugs to treat CLL that has returned or is unresponsive to treatment, or is previously untreated. The drugs work by blocking enzymes needed for cell growth.

Who is the study for?
This trial is for adults with Chronic Lymphocytic Leukemia (CLL) that's untreated, returned after treatment, or hasn't responded to past treatments. They should be relatively healthy otherwise (ECOG <=1), have adequate kidney function, and not pregnant or able to become pregnant without proper birth control measures. People can't join if they've had certain recent treatments, active infections like HIV or hepatitis B/C, severe allergies to monoclonal antibodies, other cancers within the last 3 years (with some exceptions), or conditions affecting drug absorption.Check my eligibility
What is being tested?
The trial tests a combination of drugs: GDC-0199 (a Bcl-2 inhibitor), obinutuzumab (a monoclonal antibody), and ibrutinib against CLL. It aims to find the safest doses and see how well these drugs work together in treating CLL by blocking enzymes cancer cells need for growth and targeting specific cells.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as infusion reactions from obinutuzumab; liver enzyme changes due to GDC-0199; bleeding risks from Ibrutinib; fatigue; digestive issues like nausea or diarrhea; blood cell count changes which could increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active and can carry on all pre-disease activities without restriction.
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I have CLL, show symptoms, haven't had chemotherapy, and meet certain lab criteria.
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I have been diagnosed with CLL according to WHO standards.
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I am following the required birth control methods.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neoplasm, Residual
Maximum tolerated dose of Bcl-2 inhibitor GDC-0199 in combination with obinutuzumab and ibrutinib (Phase Ib)
Secondary outcome measures
Baseline prognostic factors
Emotional distress assessment
Health related quality of life
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (obinutuzumab, ibrutinib, Bcl-2 inhibitor GDC-0199)Experimental Treatment6 Interventions
Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

Kerry RogersLead Sponsor
1 Previous Clinical Trials
Kerry Rogers, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
64 Total Patients Enrolled

Frequently Asked Questions

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

What goals is this experiment attempting to achieve?

"The primary goal of this trial, monitored for up to two months post-treatment, is to determine the maximum tolerated dose of Bcl-2 inhibitor GDC-0199 in combination with obinutuzumab and ibrutinib (Phase Ib). Secondary objectives include tracking adverse events according to National Cancer Institute Common Terminology Criteria version 4.0; recording patients that reach a target dose of Bcl-2 inhibitor GDC-0199; and examining baseline prognostic factors through logistic regression analysis."

Answered by AI

What is the limit of enrollees for this scientific experiment?

"Unfortunately, no more participants are being sought for this experiment. The study was first published on August 3rd 2015 and the most recent update took place November 16th 2022. However, there is a plethora of alternative studies recruiting; 1520 trials with CLL patients and 400 involving GDC-0199 inhibitors require enrolment currently."

Answered by AI

What maladies does Bcl-2 Inhibitor GDC-0199 typically address?

"Bcl-2 Inhibitor GDC-0199 is traditionally used to treat small lymphocytic lymphoma, though its therapeutic applications extend to refractory follicular lymphoma and waldenstrom macroglobulinemia as well."

Answered by AI

What prior research has been undertaken concerning the effects of Bcl-2 Inhibitor GDC-0199?

"Presently, there are 52 Phase 3 clinical trials and 400 active studies studying Bcl-2 Inhibitor GDC-0199. Out of the 13115 locations running these trials, most of them can be found in Edmonton, Alberta."

Answered by AI

Are there still vacancies available for this research endeavor?

"This trial is not accepting participants as of the present moment. It was first put on clinicaltrials.gov in August 3rd 2015, and its last edit was November 16th 2022. For those looking for alternative studies, there are 1,520 trials searching for patients with chronic lymphocytic leukemia (CLL) and 400 recruiting individuals who need Bcl-2 inhibitor GDC-0199 treatment."

Answered by AI
Recent research and studies
~7 spots leftby Dec 2024