A Phase 2 interventional study of KRT-232 and TL-895 in Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV-MF) and Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF), sponsored by Kartos Therapeutics, Inc.. Recruiting at 29 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-09.
Sponsored by Kartos Therapeutics, Inc. (part of Ipsen) · Phase 2, Interventional, and Treatment
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.
625 studies on the registry are indexed under Primary Myelofibrosis; 124 are open to participants now.
This study's planned enrollment of 52 is above the median of 43 across 489 interventional studies indexed under Primary Myelofibrosis.
Browse Primary Myelofibrosis studies →Kartos Therapeutics, Inc. is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
First submitted before Kartos Therapeutics, Inc. became part of Ipsen.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
KRT-232 administered orally as 240 mg once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles
Drug: KRT-232
TL-895 administered orally as 150 mg twice daily continuously in 28-day cycles
Drug: TL-895
Spleen Volume Reduction (SVR)
The proportion of subjects achieving ≥35% SVR at Week 24 by MRI/CT (central review)
Time frame: 24 weeks
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
Time frame: 24 weeks
Spleen Response Duration
Time from initial SVR of ≥35% by MRI/CT (central review) until progression
Time frame: 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
Time frame: 24 weeks
Overall Survival (OS)
Time from first dose to death from any cause
Time frame: 48 months
Progression free survival (PFS)
Time from randomization to either first occurrence of disease progression or death due to any cause
Time frame: 48 months
Started Apr 2021 (actual). Primary completion is estimated for May 2024, 37 months after the start.
Of 30 industry-sponsored phase 2 interventional studies under Primary Myelofibrosis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 66. This study's planned 37 months is above that.
Counting every sponsor, half of 98 studies reached it within 66 months; a quarter within 32 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Navtemadlin · Flixebrutinib