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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

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

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

Primary outcome measures

Spleen Volume Reduction (SVR)

Secondary outcome measures

Improvement in Total Symptom Score (TSS)

Overall Survival (OS)

Progression free survival (PFS)

+2 more

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kartos Therapeutics, Inc.Lead Sponsor

15 Previous Clinical Trials

1,398 Total Patients Enrolled

3 Trials studying Primary Myelofibrosis

537 Patients Enrolled for Primary Myelofibrosis

Media Library

KRT-232 (Janus Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04878003 — Phase 2

Primary Myelofibrosis Research Study Groups: Arm 1, Arm 2

Primary 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

Frequently Asked Questions

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

Is KRT-232 a new medication?

"KRT-232 is being studied in 13 different ongoing clinical trials, one of which is in Phase 3. 582 research sites are conducting the trials for KRT-232 with several based out of Katowice and New york City."

Answered by AI

Could you inform me how many hospitals are participating in this clinical trial?

"To make the enrollment process as convenient as possible for patients, this clinical trial has 4 locations with plans to enroll patients. These sites are situated in Houston, Canton, Whittier, and other cities."

Answered by AI

How many test subjects are in this experiment?

"In order to conduct this study, 52 patients that fit the pre-determined inclusion criteria are required. The sponsor, Kartos Therapeutics, Inc., has chosen MD Anderson Cancer Center in Houston, Texas and Gabrail Cancer Center in Canton, Ohio as two of the locations where the trial will take place."

Answered by AI

Has KRT-232 received any official recognition from the FDA?

"KRT-232 falls into the category of a Phase 2 trial drug, which means that while there is data suggesting it is safe, there is none affirming that it is an effective treatment. Our team has given it a safety score of 2."

Answered by AI

Are there any vacancies in this experiment for new participants?

"Yes, the information available on clinicaltrials.gov indicates that this study is still looking for patients. This trial was first posted on April 13th 2021 and was last updated on May 5th, 2022. The study requires 52 participants who will be recruited from 4 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

2021. "Study of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04878003.

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