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Antimetabolite

Venetoclax + Cytarabine for Acute Myeloid Leukemia

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection

Age > 55 years with no menses for 12 or more months without an alternative medical cause

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization until the primary analysis cut-off date of february 15 2019; the median follow-up time was 12.0 months (range: 0.2-17.0) in the placebo arm and 12.0 months (range: 0.1-17.6) in the venetoclax arm.

Awards & highlights

Study Summary

This trial is testing if a new cancer drug, when combined with another cancer drug, can improve overall survival for people with acute myeloid leukemia.

Who is the study for?

This trial is for treatment-naive patients with acute myeloid leukemia who are unfit for intensive chemotherapy. They must be aged ≥75 or 18-74 with certain health conditions, have an ECOG performance status of 0-3, adequate liver and kidney function, a life expectancy of at least 12 weeks, and agree to contraception if applicable. Exclusions include prior malignancies (with some exceptions), known CNS involvement by AML, active hepatitis B/C infections, HIV infection.Check my eligibility

What is being tested?

The study aims to determine if venetoclax combined with low-dose cytarabine improves survival compared to low-dose cytarabine and placebo in elderly or less fit patients with AML. Participants will either receive the combination therapy or the standard care (cytarabine plus placebo) to assess effectiveness.See study design

What are the potential side effects?

Venetoclax may cause side effects like diarrhea, nausea, risk of infection due to low white blood cell counts (neutropenia), fatigue, coughing up blood (hemoptysis), and potential tumor lysis syndrome which can affect kidneys. Cytarabine can also lead to fever with low white blood cells (febrile neutropenia), bleeding issues due to reduced platelets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys work well enough, with a creatinine clearance rate of at least 30 mL/min.

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I am over 55 and have not had a period for at least 12 months without another health reason.

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I am 55 or younger, haven't had a period for a year without other causes, and my FSH level is over 40.

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My liver is not working perfectly, and my bilirubin levels are a bit high.

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I have AML and can't undergo intensive chemotherapy.

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I have a heart condition that needed treatment or my heart's pumping ability is reduced.

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My kidney function is low but not severely impaired.

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I have some trouble doing my daily activities but don't need constant care.

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I have had surgery to remove my ovaries or uterus, making me unable to have children.

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I am 75 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ response was assessed at the end of cycle 1 and every 3 cycles thereafter to the end of treatment. median treatment duration at the 15 february 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~response was assessed at the end of cycle 1 and every 3 cycles thereafter to the end of treatment. median treatment duration at the 15 february 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively.

This trial's timeline: 3 weeks for screening, Varies for treatment, and response was assessed at the end of cycle 1 and every 3 cycles thereafter to the end of treatment. median treatment duration at the 15 february 2019 cut-off date was 1.7 months (range: 0.1-14.2) and 3.9 months (range: 0.0-17.1) in each group respectively. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Change From Baseline in Global Health Status / Quality of Life

Change From Baseline in Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a

Event-free Survival (EFS)

+14 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471

33%

Neutropenia

11%

Neutrophil count decreased

11%

Blood creatinine increased

11%

Hypokalaemia

11%

Dermatitis

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%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Venetoclax + Low Dose Cytarabine (LDAC)Experimental Treatment2 Interventions

Venetoclax 600 mg orally every day (QD) plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Group II: Placebo + LDACPlacebo Group2 Interventions

Matching placebo to venetoclax orally QD plus LDAC 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Cytarabine

2016

Completed Phase 3

~3310

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor

954 Previous Clinical Trials

500,833 Total Patients Enrolled

AbbVie Inc.Study DirectorAbbVie

264 Previous Clinical Trials

101,346 Total Patients Enrolled

Media Library

Cytarabine (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT03069352 — Phase 3

Acute Myeloid Leukemia Research Study Groups: Placebo + LDAC, Venetoclax + Low Dose Cytarabine (LDAC)

Acute Myeloid Leukemia Clinical Trial 2023: Cytarabine Highlights & Side Effects. Trial Name: NCT03069352 — Phase 3

Cytarabine (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03069352 — Phase 3

Frequently Asked Questions

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

When will Venetoclax likely be available to the public?

"There is both efficacy and safety data available for Venetoclax because it has been studied in a Phase 3 clinical trial."

Answered by AI

What is the precedent for using Venetoclax in medical trials?

"Venetoclax is being studied in 448 active clinical trials, 86 of which are Phase 3 studies. Many of these research projects are based in Edmonton, Alberta; however, there are 16706 total locations where Venetoclax trials are running."

Answered by AI

Is it currently possible to enroll in this trial?

"As of right now, this clinical trial is not actively recruiting patients. The listing was first posted on May 23rd, 2017 and updated most recently on July 15th, 2022. If you're interested in other trials, there are currently 1591 leukemia studies and 448 Venetoclax trials admitting patients."

Answered by AI

How many people are being given the chance to participate in this experiment?

"Currently, this study is not recruiting patients. However, it was first posted on 5/23/2017 and was most recently updated on 7/15/2022. There are 1591 trials actively enrolling patients with leukemia and 448 studies for Venetoclax that are currently looking for participants."

Answered by AI

What are the main medical conditions that Venetoclax is used to manage?

"Venetoclax is used to treat leptomeningeal metastases, but it can also help patients with chronic lymphocytic leukemia (cll), acute promyelocytic leukemia, and meningeal leukemia."

Answered by AI

Recent research and studies

BloodJournal

Venetoclax Plus LDAC for Newly Diagnosed AML Ineligible for Intensive Chemotherapy: A Phase 3 Randomized Placebo-controlled Trial

Wei, Andrew H., Pau Montesinos, Vladimir Ivanov, Courtney D. DiNardo, Jan Novak, Kamel Laribi, Inho Kim, et al.. 2020. “Venetoclax Plus LDAC for Newly Diagnosed AML Ineligible for Intensive Chemotherapy: A Phase 3 Randomized Placebo-controlled Trial”. Blood. American Society of Hematology. doi:10.1182/blood.2020004856.

Blood Cancer JournalJournal

6-month Follow-up of VIALE-C Demonstrates Improved and Durable Efficacy in Patients with Untreated AML Ineligible for Intensive Chemotherapy

Wei, Andrew H., Panayiotis Panayiotidis, Pau Montesinos, Kamel Laribi, Vladimir Ivanov, Inho Kim, Jan Novak, et al.. 2021. “6-month Follow-up of VIALE-C Demonstrates Improved and Durable Efficacy in Patients with Untreated AML Ineligible for Intensive Chemotherapy”. Blood Cancer Journal. Springer Science and Business Media LLC. doi:10.1038/s41408-021-00555-8.

Blood Cancer JournalJournal

6-month Follow-up of VIALE-C Demonstrates Improved and Durable Efficacy in Patients with Untreated AML Ineligible for Intensive Chemotherapy

Clinical Drug InvestigationJournal

Bioavailability Evaluation of Venetoclax Lower-strength Tablets and Oral Powder Formulations to Establish Interchangeability with the 100 Mg Tablet