Primary Myelofibrosis (PMF)Phase 2NCT04878003

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

A Phase 2 study testing KRT-232 and TL-895 in people with Primary Myelofibrosis (PMF) and Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), run by Kartos Therapeutics, Inc. at 29 sites in 9 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF) The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)
What is being tested?: KRT-232 and TL-895
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 29 sitesin 9 countries
Study dates: 13 Apr 2021to Oct 2025
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
High-risk, or intermediate-1 and 2 risk, defined by Dynamic International Prognostic System (DIPSS)
ECOG of 0 or 1

Who cannot join

Subjects who are positive for p53 mutation (Arm 1)
Prior MDM2 inhibitor therapy or p53-directed therapy (Arm 1)
Prior treatment with any JAK inhibitor
Prior splenectomy
Splenic irradiation within 24 weeks prior to randomization
Prior allogeneic stem-cell transplantation or plans for allogeneic stem-cell transplant

Show all 9Show fewer

History of major organ transplant
Grade 2 or higher QTc prolongation
Major hemorrhage or intracranial hemorrhage within 24 weeks prior to randomization

Trial locations and contacts

29 sites in 9 countries.

John Mei contact

650-542-0136

jmei@kartosthera.com

Jordan Blevins contact

650-542-0136

jblevins@kartosthera.com

Country

City, postcode or hospital

Sites recruiting now only

29 sites in 9 countries

Russia6 sites, 6 recruiting

Botkin City Clinical Hospital
Moscow, 125284
Recruiting
Republican Hospital n.a. V.A. Baranov
Petrozavodsk, 185019
Recruiting
Pavlov First Saint Petersburg State Medical University
Saint Petersburg, 197022
Recruiting
Almazov National Medical Research Center
Saint Petersburg, 197341
Recruiting
Almazov National Medical Research Centre
Saint Petersburg, 197341
Recruiting
Samara State Medical University
Samara, 443099
Recruiting

Other trials in Russia

Bulgaria5 sites, 5 recruiting

UMHAT Georgi Stranski
Pleven, 5800
Recruiting
Medical Centre Hipokrat N
Plovdiv, 4000
Recruiting
UMHAT Sv. Ivan Rilski EAD
Sofia, 1431
Recruiting
Military Medical Academy
Sofia, 1606
Recruiting
Specialized Hospital for Active Treatment of Hematologic Diseases
Sofia, 1756
Recruiting

Other trials in Bulgaria

United States4 sites, 4 recruiting

Gabrail Cancer Center
Canton, Ohio, 44718
Recruiting
Innovative Clinical Research Institute
Glendale, California, 90603
Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Recruiting
Innovative Clinical Research Institute
Whittier, California, 90603
Recruiting

Other trials in United States

Mexico4 sites, 4 recruiting

Centro de Investigacion Medica Aquascalientes (CIMA)
Aguascalientes, 20116
Recruiting
Unidad de Investigacion CIMA SC
Chihuahua City, 31200
Recruiting
Centro de Investigacion Clinica de Oaxaca (CICLO)
Oaxaca City, 68020
Recruiting
Sociedad de Metabolismo Y Corazon - SOMECO
Veracruz, 91900
Recruiting

Other trials in Mexico

Georgia3 sites, 3 recruiting

JSC EVEX Hospitals
Kutaisi, 4600
Recruiting
LTD M.Zodelava Hematology Centre
Tbilisi, 112
Recruiting
K.Eristavi National Center of Experimental and Clinical Surgery
Tbilisi, 159
Recruiting

Other trials in Georgia

Poland3 sites, 3 recruiting

Samodzielny Publiczny Zakład Opieki Zdrowotnej Zespół Szpitali Miejskich
Katowice, 40-519
Recruiting
Szpital Wojewodzki w Opolu Sp. z o.o., Oddzial Hematologii i Onkologii Hematologicznej
Opole, 45-061
Recruiting
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o.
Słupsk, 76-200
Recruiting

Other trials in Poland

Belarus2 sites, 2 recruiting

Republican Scientific Practical Center of Radiation Medicine and Human Ecology
Belarus’, 246040
Recruiting
Minsk Scientific and Practice Center of Surgery, Transplantology and Hematology
Minsk, 220045
Recruiting

Other trials in Belarus

South Africa1 site, 1 recruiting

Wits Baragwanath Clinical Hematology Department
Soweto, 1519
Recruiting

Other trials in South Africa

Ukraine1 site, 1 recruiting

City Hematology Center of Municipal Non-Profit Enterprise City Clinical Hospital #4 of Dnipro City Council
Dnipro, 49102
Recruiting

Other trials in Ukraine

About this study

Official title: An Open-Label, Multicenter, Phase 2 Study Assessing the Safety and Efficacy of KRT-232 or TL-895 in Janus Associated Kinase Inhibitor Treatment-Naïve Myelofibrosis

This study evaluates either KRT-232 or TL-895 in treatment naïve patients with myelofibrosis (MF)

The study will be conducted in 2 stages. Stage 1 will evaluate safety, tolerability, and efficacy of either KRT-232 (Arm 1) or TL-895 (Arm 2) in treatment naïve patients. Stage 2 will expand enrollment in Arm 1 and/or Arm 2 if expansion criteria is met.

Conditions: Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)
Being tested: KRT-232, TL-895
Keywords: navtemadlin
Medical subject headings: Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KRT-232Drug
KRT-232, administration by mouth
TL-895Drug
TL-895, administration by mouth

Study groups in NCT04878003
Study group	Role	What they receive
Arm 1	Experimental	KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles Receives: Drug: KRT-232
Arm 2	Experimental	TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles Receives: Drug: TL-895

What is being measured

The primary outcome is the main question the study is designed to answer.

Spleen Volume Reduction (SVR)
The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)
Measured: 24 weeks

Secondary outcomes (5)

Improvement in Total Symptom Score (TSS)
The proportion of subjects who have at least a 50% reduction from Baseline to Week 24 in the total symptom score as measured by the MF-SAF v4.0
Measured: 24 weeks
Spleen Response Duration
Time from initial SVR of ≥35% by MRI/CT (central review) until progression
Measured: 48 months
Rate of conversion from RBC transfusion dependent to independent
The proportion of subjects who convert from transfusion dependent to transfusion independent at Week 24
Measured: 24 weeks
Overall Survival (OS)
Time from first dose to death from any cause
Measured: 48 months
Progression free survival (PFS)
Time from randomization to either first occurrence of disease progression or death due to any cause
Measured: 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 2021Oct 2025

First posted7 May 2021
Study start13 Apr 2021
Primary completionMay 2024 (estimated)
Study completionOct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Primary Myelofibrosis (PMF)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04878003
Sponsor's protocol ID: KRT-232-114
Status last verified: May 2022
First submitted: 4 May 2021
Last updated: 9 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

John Mei

650-542-0136

jmei@kartosthera.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
Not yet recruitingPhase 2
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
RecruitingPhase 1
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Polycythemia Vera (PV), Myelofibrosis (MF)
Active, not recruitingPhase 1
Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (Post-PV MF)
Active, not recruitingPhase 2
Extended Access of Momelotinib in Adults With Myelofibrosis
Neoplasms, Post-polycythemia Vera Myelofibrosis (Post-PV MF)

All Primary Myelofibrosis (PMF) trials