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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
Must not have
Diagnosis of one of the following: Acute Promyelocytic Leukemia (APML), Acute leukemia with CNS status 3 involvement, Philadelphia chromosome positive leukemia (Ph+ ALL, MPAL, or AUL), Fanconi Anemia, Shwachman-Diamond syndrome, or any other bone marrow failure syndrome or DNA repair disorder, Wilson's Disease or other copper-metabolism disorder, Pregnant or breastfeeding, Uncontrolled infection, Received greater than 13.6 Gray (Gy) prior radiation to the mediastinum, Unable to swallow tablets, Receipt of growth factors within 7 days prior to enrollment, Currently receiving another investigational drug, Currently receiving anti-cancer agents (with the exception of intrathecal (IT) agents or hydroxyurea), Unable to comply with the safety monitoring requirements of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have been diagnosed with certain types of leukemia, genetic disorders, or other medical conditions. You are pregnant or breastfeeding, have an uncontrolled infection, have received a high amount of radiation to the chest area, cannot swallow pills, have recently received certain medications or treatments, are currently taking experimental drugs or other anti-cancer medications (with a few exceptions), or are unable to follow the safety monitoring requirements of the study.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of combining venetoclax and Vyxeos (dose limiting toxicities)
Treatment related toxicities
Secondary study objectives
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%
Sepsis
11%
SARS-CoV-2 test positive
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
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: 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
~2200

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
827 Previous Clinical Trials
6,564,426 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
~1 spots leftby Jan 2025
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