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Janus Kinase Inhibitor

KRT-232 or TL-895 for Myelofibrosis

Phase 2
Recruiting
Research Sponsored by Kartos Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG of 0 or 1
Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
Must not have
Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant
Prior splenectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will study two different drugs to treat myelofibrosis in patients who have not received treatment before. The first stage will evaluate the safety and effectiveness of the drugs, and the second stage will enroll more patients in the successful drug group.

Who is the study for?
This trial is for patients with myelofibrosis who haven't had treatment before. They should have a confirmed diagnosis of primary or secondary myelofibrosis, be at high-risk or intermediate risk according to DIPSS, and have good physical functioning (ECOG 0-1). People can't join if they've had certain previous treatments like JAK inhibitors, splenectomy, stem-cell transplant, or if they have specific mutations (p53), heart issues (QTc prolongation), or recent major bleeding.
What is being tested?
The study tests two drugs: KRT-232 and TL-895 in people who haven’t received any prior treatment for myelofibrosis. It's split into two stages; the first checks safety and effectiveness of each drug separately. If successful, stage two will continue with more participants in either one or both groups.
What are the potential side effects?
While not specified here, common side effects for new treatments like KRT-232 and TL-895 might include nausea, fatigue, liver enzyme changes leading to potential liver damage, blood count abnormalities which could increase infection risk or cause anemia/bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I have been diagnosed with a form of myelofibrosis.
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My condition is classified as high or intermediate risk by DIPSS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or plan to have a stem-cell transplant from a donor.
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I have had my spleen removed.
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I have previously received MDM2 or p53-targeted therapy.
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My cancer has a p53 mutation.
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I have had a major organ transplant.
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I have not had a major bleeding or brain bleeding in the last 6 months.
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I have been treated with a JAK inhibitor before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Spleen Volume Reduction (SVR)
Secondary study objectives
Improvement in Total Symptom Score (TSS)
Overall Survival (OS)
Progression free survival (PFS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles
Group II: Arm 1Experimental Treatment1 Intervention
KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TL-895
2020
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Kartos Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
1,998 Total Patients Enrolled

Media Library

KRT-232 (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04878003 — Phase 2
Myelofibrosis Research Study Groups: Arm 1, Arm 2
Myelofibrosis Clinical Trial 2023: KRT-232 Highlights & Side Effects. Trial Name: NCT04878003 — Phase 2
KRT-232 (Janus Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04878003 — Phase 2
~12 spots leftby Nov 2025
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