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Bruton's Tyrosine Kinase Inhibitor

Venetoclax + BTK Inhibitors for Chronic Lymphocytic Leukemia

Phase 2
Recruiting
Led By Alessandra Ferrajoli, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have received at least 12 months of ibrutinib or acalabrutinib therapy and have measurable CLL
Patients must have a diagnosis of CLL/CLL and have high-risk cytogenetic features or molecular features, defined as: del(17p), mutated TP53, complex metaphase karyotype
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial looks at venetoclax + ibrutinib to treat high-risk CLL. Both drugs work differently to stop cancer cell growth.

Who is the study for?
Adults with high-risk Chronic Lymphocytic Leukemia (CLL) who've had at least a year of Ibrutinib or Acalabrutinib treatment. They should be relatively healthy, with good kidney and liver function, no severe heart issues, and able to follow the study plan. Pregnant women can't join, nor those with other active cancers or infections.Check my eligibility
What is being tested?
The trial is testing if adding Venetoclax to ongoing Ibrutinib or Acalabrutinib therapy improves outcomes for CLL patients who haven't fully responded after 12 months of treatment. It's an open-label phase II study where everyone knows what treatments are given.See study design
What are the potential side effects?
Venetoclax may cause tumor lysis syndrome (a rapid release of cells into the blood), gastrointestinal symptoms like nausea and diarrhea, low blood cell counts increasing infection risk, fatigue, and possibly liver problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been on ibrutinib or acalabrutinib for over a year for my CLL.
Select...
My CLL diagnosis includes high-risk features like del(17p), mutated TP53, or a complex karyotype.
Select...
I am 18 years old or older.
Select...
I am able to care for myself and perform daily activities.
Select...
My bone marrow is working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The primary endpoint will be the rate of MRD-negativity in the bone marrow, using an assay method with at least 0.01% sensitivity after 12 cycles of combination therapy. One cycle is 4 weeks of treatment.
Secondary outcome measures
Determine complete remission CR/complete remission with incomplete hematologic recovery CRi rate of combination therapy in patients who were not in CR/Cri at study initiation and estimate the time to best response with this combination.
Determine the cumulative rate of bone marrow minimal residual disease (MRD)-free complete responders by an assay method with at least 0.01% sensitivity and median time to MRD-negativity.
Determine the overall survival.
+2 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Dermatitis
11%
Hypokalaemia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, ibrutinib, acalabarutinib)Experimental Treatment3 Interventions
Patients receive venetoclax PO QD and ibrutinib PO QD and acalabrutinib PO BID. Treatment repeat every 4 weeks for up to 24 cycles in the absence of disease progression or unaccepted toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880
Venetoclax
2019
Completed Phase 3
~1990
Acalabrutinib
2020
Completed Phase 2
~2050

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,306 Total Patients Enrolled
Alessandra Ferrajoli, MDPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
357 Total Patients Enrolled
Philip A ThompsonPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
8 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03128879 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (venetoclax, ibrutinib, acalabarutinib)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT03128879 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03128879 — Phase 2

Frequently Asked Questions

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

What is the upper limit of participation for this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that recruitment for this drug trial is ongoing, having been initially posted on June 16th 2017 and last updated on September 21st 2022. The research seeks to enroll 90 individuals at one medical location."

Answered by AI

What other experimental trials have included Venetoclax as a component?

"At the present time, 343 clinical trials are being conducted to examine the efficacy of Venetoclax. Of those active studies, 45 have reached Phase 3 status. Moreover, there are over 11 thousand medical centres running these experiments around the world - with a large concentration in Edmonton, Alberta."

Answered by AI

Could members of the public join this trial at present?

"According to clinicaltrials.gov, this medical trial is currently recruiting subjects. The study was initially posted on June 16th 2017 and the most recent update was made on September 21st 2022."

Answered by AI

How is Venetoclax typically deployed to ameliorate ailments?

"Venetoclax can be a viable treatment option for individuals dealing with waldenstrom macroglobulinemia, small lymphocytic lymphoma and the common chronic lymphocytic leukemia (cll)."

Answered by AI

Has Venetoclax been formally endorsed by the FDA?

"The safety of Venetoclax has been rated a 2 due to the fact that it is in Phase 2 clinical trials, meaning there exist some data that demonstrate its security but not yet evidence for efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
2017. "Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03128879.
~12 spots leftby Jun 2025
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