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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

No Placebo-Only Group

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 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

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%

SARS-CoV-2 test positive

11%

Sepsis

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%

Study treatment Arm

Bendamustine + Rituximab Crossover Substudy

Venetoclax + Rituximab Re-Treatment Substudy

Venetoclax + Rituximab Main Study

Bendamustine + Rituximab Main Study

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2240

0 / 5Eligibility criteria met