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Antineoplastic Agent

Entospletinib for Acute Myeloid Leukemia

Phase 3
Waitlist Available
Research Sponsored by Kronos Bio
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 cycle 1 day 1 to 30 days following study treatment completion, (cycle length = 42 days) maximum up to 198 days
Awards & highlights

Study Summary

This trial will compare the effectiveness of a new drug, entospletinib, to a placebo when given with standard chemotherapy to patients with a specific type of acute myeloid leukemia who have not been treated before. The primary outcome measure will be the rate of molecularly defined measurable residual disease.

Eligible Conditions
  • NPM1-mutated Acute Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cycle 1 day 1 to 30 days following study treatment completion, (cycle length = 42 days) maximum up to 198 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 day 1 to 30 days following study treatment completion, (cycle length = 42 days) maximum up to 198 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
Number of Participants With Measurable Residual Disease (MRD) Negative Complete Response (CR) Rate
Secondary outcome measures
Event-free Survival (EFS)
Number of Participant With Complete Response (CR) After 2 Cycles of Chemotherapy
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
+2 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358
65%
Infusion related reaction
59%
Neutrophil count decreased
41%
Upper respiratory infection
29%
Aspartate aminotransferase increased
29%
Platelet count decreased
24%
Alanine aminotransferase increased
18%
Sinusitis
18%
Urinary tract infection
12%
Tooth infection
6%
Bronchial infection
6%
Acute Coronary Syndrome
6%
Febrile neutropenia
6%
Sepsis
6%
Infections and infestations - Other, specify
6%
Nail infection
6%
Rhinitis infective
6%
Tumor lysis syndrome
6%
Infusion Related Reaction
6%
Wound infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2 and MTD (800 mg Entospletinib Daily)
Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intensive Chemotherapy + Entospletinib (ENTO)Experimental Treatment3 Interventions
Participants received intensive chemotherapy (cytarabine and anthracycline [daunorubicin or idarubicin]) in combination with entospletinib (ENTO).
Group II: Intensive Chemotherapy + PlaceboPlacebo Group3 Interventions
Participants received intensive chemotherapy (cytarabine and anthracycline [daunorubicin or idarubicin]) in combination with the matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Entospletinib
2017
Completed Phase 2
~120
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

Kronos BioLead Sponsor
2 Previous Clinical Trials
304 Total Patients Enrolled

Frequently Asked Questions

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

Could you tell me if this experiment is available to people who are less than 60 years old?

"In order to be a part of this study, individuals must be between 18-74 years old. Out of the 527 clinical trials available for patients under 18 and 1371 for those over 65, this is the only one that meets these age requirements."

Answered by AI

If I qualify, may I take part in this experiment?

"This clinical trial is looking for 180 participants total, who currently have leukemia, myeloid, acute. The patients must also meet the following criteria: be between 18 and 74 years old, have untreated de novo acute myeloid leukemia (AML), AML with myelodysplastic syndromes (MDS) features, or therapy-related AML,, be a candidate for intensive induction therapy., Nucleophosmin-1 (NPM1)-mutated disease documented in a local or the Sponsor's central testing facility., Note: Participants with local test results for nucleophosmin-1"

Answered by AI

Are there any open positions for test subjects in this experiment?

"From what is available on clinicaltrials.gov, it appears that this particular trial is open for recruitment. The initial posting was on 11/30/2021 with the most recent update taking place on 10/24/2022."

Answered by AI

How many people are being asked to participate in this clinical trial?

"One hundred and eighty individuals that fit the pre-determined inclusion criteria are necessary for this clinical trial. Eligible patients have the opportunity to participate at Princess Margaret Cancer Centre in Toronto, South carolina or Hollings Cancer Center in Charleston, Texas."

Answered by AI

What are the primary medical conditions that Entospletinib has been shown to improve?

"leptomeningeal metastases can often be treated with Entospletinib. This pharmaceutical is also effective against acute promyelocytic leukemia, meningeal leukemia, and blast phase chronic myelocytic leukemia."

Answered by AI

Are there other precedents for Entospletinib's therapeutic effect?

"As of now, there are 251 live studies researching Entospletinib with 62 trials in Phase 3. While most of the clinical trials for Entospletinib are based in Providence, Rhode island, there are 9883 locations operating clinical trials for Entospletinib."

Answered by AI

In how many different areas is this experiment being conducted today?

"So far, this clinical trial has recruited patients from Princess Margaret Cancer Centre in Toronto, South carolina, Hollings Cancer Center in Charleston, Texas, and St. Francis Cancer Center in Greenville, Indiana with 14 other locations currently being scouted."

Answered by AI

Are there long-term repercussions to taking Entospletinib?

"There is some data that entospletinib is efficacious and it has undergone multiple rounds of testing for safety, so it received a score of 3."

Answered by AI
~4 spots leftby Mar 2025