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Tyrosine Kinase Inhibitor

Lanraplenib + Gilteritinib for Leukemia

Phase 1 & 2
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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
FMS-like tyrosine kinase 3 (FLT3)-mutated disease documented in a local reference laboratory at the time of consideration for enrollment in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a combination of two drugs to treat FLT3-mutated AML, a type of blood cancer. The goal is to see if the combination is safe.

Who is the study for?
This trial is for adults over 18 with a type of blood cancer called FLT3-mutated acute myeloid leukemia (AML) that has come back or didn't respond to treatment. Participants should be in fair health, not pregnant, and free from serious infections like hepatitis B/C or HIV. They can't join if they have certain heart conditions, active COVID-19, other cancers unless specified exceptions apply, or are on immunosuppressive therapy.Check my eligibility
What is being tested?
The study tests the safety of combining two drugs: Lanraplenib (LANRA) and Gilteritinib. It's specifically for patients whose AML has returned after treatment or hasn’t responded at all. The goal is to see how well these patients tolerate this drug combination.See study design
What are the potential side effects?
Possible side effects may include liver problems, bleeding disorders due to coagulation issues, heart complications such as abnormal heartbeat rhythms, and increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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My condition is FLT3-mutated as confirmed by a lab test.
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I am over 18 and have had treatment for acute myeloid leukemia before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Part 1 and Part 2: Number of Participants who Experience a Dose-Limiting Toxicity (DLT) for Lanraplenib (LANRA)
Part 1 and Part 2: Number of Participants who Experience a Treatment-Emergent Adverse Event (TEAE)
Part 1: Maximally Tolerated Dose (MTD) of Lanraplenib (LANRA)
+1 more
Secondary outcome measures
Part 1 and Part 2: Composite Complete Response (CR) Rate
Part 1 and Part 2: Composite Complete Response (CR) with Partial Hematologic Recovery (CRh)
Part 1 and Part 2: Duration of Response (DoR)
+5 more

Side effects data

From 2019 Phase 2 trial • 152 Patients • NCT03100942
11%
Alanine aminotransferase increased
11%
Arthralgia
11%
Rash
11%
Upper respiratory tract infection
11%
Aspartate aminotransferase increased
11%
Fatigue
8%
Gastroenteritis viral
8%
Nasopharyngitis
8%
Diarrhoea
8%
Dizziness
8%
Pyrexia
5%
Laryngitis
5%
Lower respiratory tract infection
5%
Oral herpes
5%
Sinusitis
5%
Myalgia
5%
Dental caries
5%
Neutropenia
5%
Pruritus generalised
5%
Lymphadenopathy
5%
Bronchitis
5%
Nausea
5%
Vomiting
3%
Rheumatoid arthritis
3%
Acute coronary syndrome
3%
Fall
3%
Pancreatitis acute
3%
Suicidal ideation
3%
Seasonal allergy
3%
Furuncle
3%
Influenza
3%
Urinary tract infection
3%
Osteoarthritis
3%
Migraine
3%
Hyperhidrosis
3%
Anaemia
3%
Back pain
3%
Rash pruritic
3%
Insomnia
3%
Musculoskeletal pain
3%
Rash papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo to Tirabrutinib
Placebo on Placebo Controlled Period
Lanraplenib
Filgotinib
Tirabrutinib
Placebo to Lanraplenib
Placebo to Filgotinib

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2: Expansion CohortExperimental Treatment2 Interventions
Following identification of the maximally tolerated dose (MTD) / recommended Phase 2 dose (RP2D) of lanraplenib (LANRA) in combination with gilteritinib in Part 1, an expansion cohort will enroll. The expansion cohort will receive LANRA in combination with gilteritinib at the MTD / RP2D once daily (QD) in each 28 day cycle.
Group II: Part 1: Dose EscalationExperimental Treatment2 Interventions
Sequential cohorts of participants will receive escalating doses of lanraplenib (LANRA) once daily (QD) + gilteritinib QD in each 28 day cycle for determination of the maximally tolerated dose (MTD) / recommended Phase 2 dose (RP2D) of LANRA in combination with gilteritinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lanraplenib
2017
Completed Phase 2
~210
Gilteritinib
2014
Completed Phase 2
~560

Find a Location

Who is running the clinical trial?

Kronos BioLead Sponsor
2 Previous Clinical Trials
295 Total Patients Enrolled

Media Library

Gilteritinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05028751 — Phase 1 & 2
Acute Myeloid Leukemia Research Study Groups: Part 1: Dose Escalation, Part 2: Expansion Cohort
Acute Myeloid Leukemia Clinical Trial 2023: Gilteritinib Highlights & Side Effects. Trial Name: NCT05028751 — Phase 1 & 2
Gilteritinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05028751 — Phase 1 & 2

Frequently Asked Questions

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

Have any other scientific investigations utilized Lanraplenib?

"Lanraplenib was initially studied in 2014 at M D Anderson Cancer Center. Presently, 14 trials have been finalized and 17 are ongoing. The majority of current studies focus on recruiting from the New york City area."

Answered by AI

Are there any vacancies remaining in this clinical investigation?

"Affirmative. Clinicaltrials.gov illustrates that this clinical trial, which was initially advertised on August 5th 2022, is currently recruiting participants. There are 55 slots available in 7 medical sites across the United States of America."

Answered by AI

How many venues are hosting this research endeavor?

"This medical study is running in conjunction with Memorial Sloan Kettering Cancer Center, University of California Los Angeles (UCLA), and the University of Chicago Medical Centre. Additionally, 7 other research facilities are also involved."

Answered by AI

How many participants are currently enrolled in this experiment?

"Kronos Bio is responsible for this clinical trial, which requires 55 eligible patients to commence. Memorial Sloan Kettering Cancer Center of New york and UCLA in Los Angeles are among the locations that will be hosting the study."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Memorial Sloan Kettering Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)
2022. "A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05028751.
~0 spots leftby May 2024
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