Venetoclax for Leukemia

Phase-Based Estimates
2
Effectiveness
3
Safety
Research Site, Shenyang, China
Leukemia+3 More
Venetoclax - Drug
Eligibility
18+
All Sexes
Eligible conditions
Leukemia

Study Summary

This study is evaluating whether a drug called acalabrutinib may help treat chronic lymphocytic leukemia.

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Eligible Conditions

  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Chronic Lymphocytic Leukemia (CLL)

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Venetoclax will improve 1 primary outcome and 2 secondary outcomes in patients with Leukemia. Measurement will happen over the course of 6 years.

6 years
To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared to chemoimmunotherapy fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR] (Arm C): PFS
To evaluate the efficacy of acalabrutinib with venetoclax (Arm A) compared with FCR or BR (Arm C): PFS defined the same as above per investigator assessment.
To evaluate the efficacy of acalabrutinib with venetoclax in combination with obinutuzumab (Arm B) compared with FCR or BR (Arm C): PFS

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

3 Treatment Groups

Chemoimmunotherapy
Acalabrutinib, Venetoclax

This trial requires 780 total participants across 3 different treatment groups

This trial involves 3 different treatments. Venetoclax is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Acalabrutinib, VenetoclaxAcalabrutinib in combination with Venetoclax
Acalabrutinib, Venetoclax, ObinutuzumabAcalabrutinib in combination with Venetoclax with or without Obinutuzumab
Chemoimmunotherapy
Drug
Chemoimmunotherapy FCR: Fludarabine, Cyclophosphamide and Rituximab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
FDA approved
Venetoclax
FDA approved
Obinutuzumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 years for reporting.

Closest Location

Research Site - San Antonio, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants are required to use highly effective birth control throughout the study. show original
Men and women ≥18 years of age.
The Eastern Cooperative Oncology Group (ECOG) performance status is 0-2. show original
The patient has Chronic Lymphocytic Leukemia (CLL) if they meet the published diagnostic criteria. show original
Disease that requires treatment according to the 2018 IWCLL criteria. show original

Patient Q&A Section

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

Can leukemia be cured?

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There are a significant number of patients who do not meet criteria for cure of their leukemia. The disease remains with many patients as an asymptomatic chronic disease in the absence of treatment.

Unverified Answer

How many people get leukemia a year in the United States?

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In 2011, nearly 6 people in the United States are diagnosed with leukemia each day. The number of people diagnosed with leukemia is a lot higher in the Southern part of the country. This information is useful to anyone looking for treatment options, since they are not available everywhere. The most common type of leukemia in adults is acute lymphoblastic leukemia (ALL).

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What are the signs of leukemia?

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There is a high rate of anemia, thrombocytopenia, and pancytopenia among patients with leukemia. A routine use of routine hematological counts during the pre-treatment consultation is strongly advocated.

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What causes leukemia?

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Leukemia can result from genetic abnormalities, including chromosomal rearrangements and non-rearranged chromosome translocations, as well as ionizing radiation and chemicals. Infection with the JC virus in particular has been found to be a significant risk factor for the development of acute myeloid leukemia. The development of leukemia is also linked to other health conditions such as alcoholism, a history of childhood leukemia and exposure to ionizing radiation. A number of genetic mutations and rearrangements have been associated with the development of chronic myeloid leukemia.

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What is leukemia?

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Leukemia is a very dangerous disease with much different prognosis. This disease was named when it was first described by Richard Bright and William Halsted in 1847. What they observed in this disease was the excessive proliferation of blood cells and they noted this condition by what we now call blood smear because they found clusters of these cells. They also found that the peripheral blood cells included different number of cells, some with small size (microcytes) and other with large (macrocytes), some with immature (sideroblasts) and other with mature (polymorphs).

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What are common treatments for leukemia?

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Leukemia is treated with chemotherapy, radiotherapy, chemotherapy and surgery. Bone marrow transplantation is an important treatment for some people. There is also no cure for leukemia.

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What are the common side effects of venetoclax?

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The most frequently observed side effects associated with venetoclax were rash/mesh like or itchy, nausea, fatigue/malaise, diarrhea, and gastrointestinal perforations. Serious side effects (>10% of patients) were hyperprolactinaemia (>5 mg/dL increase), QT interval abnormal, elevated AST/ALT ratios (>2 times normal limits), leukopenia (<1000 nucleated red blood cells/μL), and elevated systolic BP (>90 mm Hg), and elevated creatinine (>1.5 times normal limits). There was also a very rare but serious case of thromboembolism.

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Does leukemia run in families?

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Results from a recent clinical trial, familial occurrence of all forms of leukemia was not found, but the risk of ALL and CLL in siblings of ALL and CLL patients is not eliminated. Therefore, hereditary factors are probably important; however, it is also possible that environmental exposures influence these diseases.

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Is venetoclax safe for people?

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The safety and efficacy data from early clinical trials of the novel BH3 mimetic MK-8041 are promising for the future use of this drug in the treatment of B-cell Chronic Lymphocytic Leukemia (CLL). This suggests venetoclax may be useful for patients in the initial stages of CLL that are not fit for standard therapies and warrant earlier clinical trials.

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What are the latest developments in venetoclax for therapeutic use?

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Venetoclax's clinical profile showed efficacy and safety, and showed a unique effect for the targeted therapy of CLL, and more specifically in SLL patients and in relapsed SLL patients.

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Does venetoclax improve quality of life for those with leukemia?

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In a recent study, findings support the use of venetoclax as a second-line therapy for treating newly diagnosed/refractory systemic juvenile myelomonocytic leukaemia (JML) and previously treated acute myelogenous leukaemia (AML) and show that venetoclax has a significant impact on HRQoL compared with that seen in the general population.

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What is the average age someone gets leukemia?

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The average age of diagnosis is 51.2 as of 2013. People were 3.8 times more likely to be diagnosed in 2013, 2013 onward, compared with 1998. The proportion of people who got leukemia was unchanged between 1998 and 2013. Older men appeared most affected in 2014.

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