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IDH2 Inhibitor

Venetoclax for Acute Myeloid Leukemia

Phase 1 & 2

Waitlist Available

Led By Steven Chan, M.D.

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is testing a new combination of drugs for relapsed or refractory AML patients to see how safe and effective it is.

Eligible Conditions

Acute Myeloid Leukemia
Cancer
IDH2 Mutation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary outcome measures

Dose Limiting Toxicity

Duration of Response

Maximum tolerated dose or Recommended Phase 2 Dose

+1 more

Secondary outcome measures

Event Free Survival

Overall Survival

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

1Treatment groups

Experimental Treatment

Group I: Venetoclax and EnadisenibExperimental Treatment2 Interventions

Enasidenib and venetoclax will be taken by mouth (orally), once a day, every day, continuously. Every 28-day period will be called a cycle. Participants will start venetoclax alone on Cycle 1 Day 1 and continue the study drug alone until Day 15. On Day 15, participants will take enasidenib and venetoclax together and will continue to take the combination of study drugs until intolerable side effects or disease worsening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enasidenib

2020

Completed Phase 2

~560

Venetoclax

2019

Completed Phase 3

~1990

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AbbVieIndustry Sponsor

954 Previous Clinical Trials

501,017 Total Patients Enrolled

University Health Network, TorontoLead Sponsor

1,468 Previous Clinical Trials

484,463 Total Patients Enrolled

CelgeneIndustry Sponsor

636 Previous Clinical Trials

128,944 Total Patients Enrolled

Frequently Asked Questions

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

Is this experimental investigation fresh and innovative?

"Since 2013, Venetoclax has been the topic of numerous medical studies. The initial research was conducted and sponsored by Celgene in 2013; it included 345 participants. After acquiring Phase 1 & 2 approval, subsequent trials have transpired across 48 countries spanning 1204 cities - currently 236 are still active."

Answered by AI

Could you elucidate the experiments conducted regarding Venetoclax?

"Venetoclax was first studied at Local Institution - 201 in 2013, and since then 57 trials have completed. There are presently 236 active studies taking place, with a notable concentration of them located in Toronto, Ontario."

Answered by AI

How many participants have enrolled in this experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, first published on November 5th 2020, is actively recruiting participants. 48 patients must be recruited from 2 different sites to complete the trial."

Answered by AI

Are volunteers currently being welcomed for this experiment?

"As documented on clinicaltrials.gov, this medical trial is presently searching for participants. It was initially made available to the public on November 5th 2020 and its most recent revisions were completed at the end of November 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

2020. "Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04092179.