← Back to Search

Bcl-2 Inhibitor

Bcl-2 Inhibitor + Obinutuzumab + Ibrutinib 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

Must not have

Specific mutations or resistance to certain treatments

Known HIV infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Select...

I have CLL, show symptoms, haven't had chemotherapy, and meet certain lab criteria.

Select...

I have been diagnosed with CLL according to WHO standards.

Select...

I am following the required birth control methods.

Exclusion Criteria

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

Select...

My cancer has specific mutations or is resistant to some treatments.

Select...

I am HIV positive.

Select...

My heart condition limits my physical activity.

Select...

My condition has progressed to Richter's transformation.

Select...

My lymphoma or leukemia has spread to my brain or spinal cord.

Select...

I do not have any uncontrolled illnesses.

Select...

I have not had any other cancers in the last 3 years.

Select...

I have not received a live vaccine recently.

Select...

I have uncontrolled autoimmune blood disorders.

Select...

I am following specific medication and diet rules.

Select...

I have experienced severe side effects from Bcl-2 inhibitors.

Select...

I cannot swallow pills or have stomach problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 years

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

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

Primary study objectives

Neoplasm, Residual

Secondary study objectives

Baseline prognostic factors

Emotional distress assessment

Health related quality of life

+8 more

Awards & Highlights

No Placebo-Only Group

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

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

Obinutuzumab

2014

Completed Phase 3

~3470

Ibrutinib

2014

Completed Phase 4

~2060