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BCL-2 Inhibitor

Venetoclax + Chemotherapy for Acute Myeloid Leukemia

Madera, CA

Phase 2

Recruiting

Led By Hiroto Inaba, MD, PhD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study enrollment to disease resistance, relapse, development of a second malignancy, or death due to any cause (up to 3 years after the last enrollment).

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if adding venetoclax to chemo can help kids with AML, by measuring if it's safe and how well it works.

See full description

Who is the study for?

This trial is for pediatric patients aged over 28 days and under 22 years with newly diagnosed acute myeloid leukemia (AML), who haven't had prior treatment except possibly one dose of intrathecal therapy or specific low-dose chemotherapy. Participants must be able to tolerate the protocol therapy, not have certain infections or diseases that could affect safety or results, and agree to use effective contraception if applicable.

What is being tested?

The study tests whether adding Venetoclax to standard chemotherapy is tolerable and effective in children with AML. It aims to see if this combination can reduce disease traces after one treatment course and improve rates of complete remission, event-free survival, and overall survival.See study design

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to lowered blood counts; plus any specific reactions related to Venetoclax which may involve gastrointestinal symptoms or liver function changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from protocol enrollment until death (up to 3 years after the last enrollment).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from protocol enrollment until death (up to 3 years after the last enrollment).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from protocol enrollment until death (up to 3 years after the last enrollment). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of death or unacceptable adverse event

Minimal residual disease (MRD)-negativity rate

Secondary study objectives

Event-free survival

Overall survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Low RiskExperimental Treatment8 Interventions

All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Cytabrine, Danunorubicin Hydrochloride, Gemtuzumab Ozogamicin, Etoposide, Mitoxantrone Hydrochloride, Gilteritinib

Group II: Intermediate RiskExperimental Treatment9 Interventions

All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Cytabrine, Danunorubicin Hydrochloride, Fludarabine Phosphate, Gemtuzumab Ozogamicin, Etoposide, Idarubin Hydrochloride, Mitoxantrone Hydrochloride, Gilteritinib

Group III: High RiskExperimental Treatment9 Interventions

All eligible patients receive intervention according to the Detailed Description section with the following: Venetoclax, Azacitidine, Cytabrine, Danunorubicin Hydrochloride, Fludarabine Phosphate, Gemtuzumab Ozogamicin, Etoposide, Idarubin Hydrochloride, Gilteritinib

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~2290

Fludarabine Phosphate

1997

Completed Phase 3

~2390