Venetoclax Extension Study for Leukemia

Not currently recruiting at 111 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Venetoclax

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study the long-term safety of a treatment called venetoclax for leukemia. Researchers are testing venetoclax on individuals who have already been using it successfully, meaning they tolerate it well and experience benefits. The trial is open to those currently participating in another venetoclax study and continue to find it helpful. The goal is to ensure the treatment remains safe and effective over time. Individuals who have been part of a venetoclax study and find it effective might find this trial suitable. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the treatment's potential availability to a broader population.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on continuing venetoclax for those already benefiting from it.

Is there any evidence suggesting that venetoclax is likely to be safe for humans?

Research has shown that venetoclax has been widely studied in patients with various types of leukemia. In one study with 158 participants, researchers assessed the safety of venetoclax. Most participants tolerated the treatment well, though some experienced side effects, with low blood cell counts and digestive issues like nausea being the most common.

Another study focused on patients with chronic lymphocytic leukemia (CLL), where safety was also a key concern. Participants experienced similar side effects, which were generally manageable.

Since the FDA has already approved venetoclax for certain types of leukemia, its safety profile is well-understood. This ongoing study aims to gather more long-term safety information. Overall, venetoclax is considered relatively well-tolerated, though monitoring for side effects remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Venetoclax is unique because it specifically targets and inhibits the BCL-2 protein, which plays a critical role in keeping cancer cells alive. Unlike traditional chemotherapy options for leukemia, which often broadly attack rapidly dividing cells, Venetoclax offers a more targeted approach, potentially reducing harm to healthy cells and minimizing side effects. Researchers are excited about Venetoclax because it represents a more precise and potentially more effective way to induce cancer cell death, offering hope for better outcomes and quality of life for patients with leukemia.

What is the effectiveness track record for Venetoclax in treating leukemia?

Research has shown that venetoclax effectively treats certain types of leukemia, such as chronic lymphocytic leukemia (CLL). In one study, patients with CLL that had returned or did not respond to previous treatments experienced a 60% overall response rate, meaning more than half of the patients had a positive reaction to the treatment. Another study found that venetoclax helped patients live longer. These findings suggest that venetoclax can be a promising option for people with specific types of leukemia, helping them manage their condition more effectively. Participants in this trial will continue receiving venetoclax at the same dose administered during their previous study. ^{1 2 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people who have been part of a venetoclax study, are still benefiting from it without major issues, and aren't pregnant or breastfeeding. Men must agree not to donate sperm during the trial.

Inclusion Criteria

I am currently taking venetoclax for my condition and it's working without severe side effects.

I am not pregnant or breastfeeding.

I agree not to donate sperm.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Extension

Participants continue to receive venetoclax at the same dose as in their previous study to obtain long-term safety data

Up to approximately 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Venetoclax

Trial Overview The study continues giving venetoclax to participants from previous trials to gather more information on its long-term safety and ongoing effectiveness in treating various types of blood cancers.

How Is the Trial Designed?

Group I: Venetoclax Experimental Treatment 1 Intervention

Venetoclax at the same dose administered to each subject during the previous study in which they were enrolled.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Venetoclax is a highly effective treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), achieving response rates of about 80% in clinical trials involving 240 patients from 2011 to 2016.

While venetoclax has an acceptable safety profile, common side effects include neutropenia and diarrhea, and there is a risk of tumor lysis syndrome (TLS), which can be managed through careful dose ramp-up and patient education, leading to no reported TLS events in ongoing trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . Brumbaugh Paradis, H., Alter, D., Llerandi, D.[2018]

In the phase III CLL14 trial, a 12-month treatment with venetoclax combined with obinutuzumab significantly improved progression-free survival and rates of undetectable minimal residual disease compared to traditional chemoimmunotherapy with chlorambucil and obinutuzumab in patients with untreated chronic lymphocytic leukaemia.

Venetoclax + obinutuzumab is a well-tolerated, chemotherapy-free treatment option for CLL, with manageable side effects like neutropenia, making it suitable for patients who cannot undergo intensive chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia. Blair, HA.[2021]

Venetoclax is an oral medication that selectively inhibits the BCL-2 protein, which helps cancer cells survive, thereby restoring the ability of these malignant cells to undergo programmed cell death (apoptosis).

It has been approved in the USA for treating chronic lymphocytic leukaemia (CLL) in patients with a specific genetic marker (17p deletion) who have already undergone at least one prior therapy, and it is being studied for various other blood cancers and conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venetoclax: First Global Approval. Deeks, ED.[2018]

Venetoclax is an effective oral treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), showing durable responses and a manageable safety profile in clinical trials, including patients with poor prognostic factors.

In combination with rituximab, venetoclax significantly improved progression-free survival and achieved undetectable minimal residual disease compared to bendamustine plus rituximab, with benefits lasting for at least 36 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia. Scott, LJ.[2020]

In a study of 82 adult patients with acute myeloid leukemia (AML), 57% were able to start venetoclax treatment safely in an outpatient setting, demonstrating its feasibility outside of the hospital.

The risk of tumor lysis syndrome (TLS) was very low, with only 2.1% of patients experiencing TLS after starting venetoclax, and 98% of patients did not require hospitalization for TLS within the first week of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient initiation of venetoclax in patients with acute myeloid leukemia. Palmer, S., Patel, A., Wang, C., et al.[2023]

Venetoclax is an effective and well-tolerated treatment for advanced hematological malignancies, particularly in patients with chronic lymphocytic leukemia, showing a satisfactory overall event rate of 73%.

The most common adverse events associated with venetoclax include nausea, diarrhea, and thrombocytopenia, but these are generally mild and manageable, with few cases of severe complications like tumor lysis syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Bcl-2 Inhibitor Venetoclax in Hematological Malignancy: A Systematic Review and Meta-Analysis of Clinical Trials. Li, Q., Cheng, L., Shen, K., et al.[2020]

In a study of 18 pediatric and young adult patients with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL), venetoclax demonstrated a complete remission rate of 61%, indicating its potential efficacy in this population.

No new safety concerns were identified with venetoclax, with myelosuppression being the most common side effect, and no deaths occurred within 30 days of starting treatment, suggesting it is a safe option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venetoclax for Children and Adolescents with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Gibson, A., Trabal, A., McCall, D., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5026291/

The potential of venetoclax (ABT-199) in chronic lymphocytic ... In the phase I trial in R/R CLL and lymphoma patients, the ORR with ibrutinib was 60%, including 16% CRs and median PFS of 13.6 months. Results varied by ...

2. venclextahcp.com venclextahcp.com/cll/efficacy/ven-g/data.html

VENCLEXTA efficacy results: 6-year overall survival 1 In patients with CLL, Grade 3 or 4 neutropenia developed in 63% to 64% of patients and Grade 4 neutropenia developed in 31% to 33% of patients when treated with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01889186?term=venetoclax&viewType=Table&rank=6

NCT01889186 | A Study of the Efficacy of ABT-199 in ... This was an open-label, multicenter, global study to determine the efficacy of ABT-199 ( Venetoclax ) monotherapy in participants with relapsed/refractory (R/R) ...

4. aacrjournals.org aacrjournals.org/cancerdiscovery/article/6/10/1106/5537/Efficacy-and-Biological-Correlates-of-Response-in

Efficacy and Biological Correlates of Response in a Phase II ... A and B, the median leukemia-free survival was 2.3 months (range, 1.0–2.7), and the median overall survival was 4.7 months (range, 2.3–6.0), in patients with ...

5. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M14-032

A Phase 2 Open-Label Study of the Efficacy and Safety ... This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy and safety of ABT-199 in 127 participants with relapsed or refractory ...

6. abbvie.com abbvie.com/content/dam/abbvie-dotcom/us/clinical-trials/venetoclax_M13-982.pdf

Venetoclax (ABT-199) M13-982 Clinical Study Report Safety was assessed in all 158 subjects; 107 subjects in the main cohort and 51 subjects in the safety expansion cohort. The data cutoff date for this final ...

7. ashpublications.org ashpublications.org/blood/article/126/23/254/112989/A-Phase-1-Study-of-Venetoclax-ABT-199-GDC-0199

A Phase 1 Study of Venetoclax (ABT-199 / GDC-0199 ... We present updated data on the safety profile and efficacy as of June 10, 2015. ... Clinical Outcomes of Venetoclax Therapy in Patients ...