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BCL-2 Inhibitor

Venetoclax + Vyxeos for Leukemia

Phase 1

Recruiting

Led By John Perentesis, MD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

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

Must have

Ages 1-39 years

Disease status: Relapsed/Refractory AML, MPAL and AUL, Relapsed/Refractory KMT2A-rearranged ALL, T-cell ALL, ETP ALL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days

Awards & highlights

Study Summary

This trial tests combining two drugs to treat leukemia in young patients who have relapsed or not responded to treatment.

Who is the study for?

This trial is for young patients aged 1-39 with acute leukemia that's relapsed or hasn't responded to treatment. They should have recovered from previous therapies and not have certain other health conditions like Fanconi Anemia or Wilson's Disease, be pregnant, breastfeeding, or unable to swallow pills.Check my eligibility

What is being tested?

The study tests combining Venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients. It aims to assess the safety of this combination therapy in those whose acute leukemia has returned or is resistant to standard treatments.See study design

What are the potential side effects?

While specific side effects are not listed here, common ones associated with Venetoclax include nausea, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems. Vyxeos may cause similar issues along with fever and rash.

Eligibility Criteria

Inclusion Criteria

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

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I am between 1 and 39 years old.

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My leukemia has returned or didn't respond to treatment.

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I can do most activities but may need help.

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I have been diagnosed with a specific type of leukemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feasibility of combining venetoclax and Vyxeos (dose limiting toxicities)

Treatment related toxicities

Secondary outcome measures

Cancer therapeutics-related cardiac dysfunction (CTRCD) in patients who have previously received anthracyclines

Disease response

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%

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: Venetoclax and Vyxeos combinationExperimental Treatment2 Interventions

Venetoclax will be given orally on Days per the assigned dose level. A single course consisting of 3 doses of Vyxeos and 7-21 doses of venetoclax depending on the assigned dose level will be administered to participants in this study. Vyxeos will be administered by central venous catheter over 90 minutes on Day 1, 3, and 5. Venetoclax is given daily by mouth per assigned dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,570 Total Patients Enrolled

7 Trials studying Leukemia

404 Patients Enrolled for Leukemia

John Perentesis, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

27 Total Patients Enrolled

1 Trials studying Leukemia

27 Patients Enrolled for Leukemia

Media Library

Venetoclax (BCL-2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03826992 — Phase 1

Frequently Asked Questions

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

Does this study permit those aged 40 or older to take part?

"According to the guidelines for this research study, only individuals aged between 1 and 39 years can be included as participants."

Answered by AI

To what extent can the usage of Venetoclax be detrimental to patients?

"Based on our assessment, Venetoclax is assigned a score of 1. This rating accounts for the limited evidence available to demonstrate its efficacy and safety as this trial is currently in Phase 1."

Answered by AI

Could you elaborate on the precedent of Venetoclax in clinical trials?

"Presently, 447 clinical trials for Venetoclax are in motion with 85 of those being Phase 3. Edmonton, Alberta is the primary site for these experiments; however 19199 other locations are running tests involving this medication."

Answered by AI

Is there still capacity for recruitment into this experiment?

"Yes, the clinicaltrials.gov information suggests that this trial is presently accepting new recruits. It was originally posted on December 27th 2018 and amended most recently on April 18th 2023. The researchers are searching for 21 patients to take part at a single site."

Answered by AI

Is it possible for me to join this research endeavor?

"Patients hoping to be part of this experiment must have a diagnosis of leukemia and fall into the 1 Year - 39 year age range. It is anticipated that around 21 patients will join the trial."

Answered by AI

How many participants are enrolled in this experiment?

"Affirmative. Clinicaltrials.gov states that this clinical trial, which was first posted on December 27th 2018, is actively enrolling participants. 21 individuals are required between 1 medical centre."

Answered by AI

What are the common indications for Venetoclax?

"Venetoclax is commonly prescribed for the treatment of acute myelocytic leukemia and its blast phase. It can also be used to address lymphoma as well as other forms of acute myeloid leukemia."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia

2018. "Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03826992.

All > Acute Myeloid Leukemia > Leukemia