MyelofibrosisPhase 2NCT04655118
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
A Phase 2 study testing TL-895 in people with Myelofibrosis and Indolent Systemic Mastocytosis, run by Telios Pharma, Inc. at 52 sites in 13 countries.
Trial summary
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis, Indolent Systemic Mastocytosis
- What is being tested?
- TL-895
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 52 sitesin 13 countries
- Study dates
- 22 Oct 2020to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Adults ≥18 years of age
- Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Adequate hematologic, hepatic, and renal functions
- MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
- Cohort 3 only: Ineligibility for JAKi treatment with a platelet count of ≥ 25 and < 50 x 10^9/L
Show all 9Show fewer
- Adults ≥18 years of age
- Confirmed diagnosis of ISM as defined by WHO diagnostic criteria based on review of bone marrow biopsy pathology report results
- Subject must have moderate-to-severe symptoms
Who cannot join
- Prior treatment with any BTK or BMX inhibitors
- Prior treatment with JAKi within 28 days prior to study treatment
- Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
- Cohort 5
- Prior treatment with any BTK or BMX inhibitors
- Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
- Diagnosis with another myeloproliferative disorder
Trial locations and contacts
52 sites in 13 countries.
52 sites in 13 countries
Italy9 sites
- Active, not recruiting
Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco - Presidio Ospedaliero G. Rodolico
Catania, 95123
- Active, not recruiting
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, 47014
- Active, not recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, 20122
- Active, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
- Active, not recruiting
Azienda Ospedaliero Universitaria Maggiore Della Carita'
Novara, 28100
- Active, not recruiting
Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia
Perugia, 06129
- Active, not recruiting
AUSL della Romagna-Ospedale S.Maria delle Croci
Ravenna, 48121
- Active, not recruiting
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Reggio Calabria, 89124
- Active, not recruiting
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma, 00161
United States6 sites, 2 recruiting
- Completed
University of Colorado - Aurora Cancer Center
Aurora, Colorado, 80045
- Completed
Gabrail Cancer Center
Canton, Ohio, 44718
- Active, not recruiting
University of Cincinnati (UC) Physicians Company, LLC
Cincinnati, Ohio, 45267
- Active, not recruiting
Ohio State University
Columbus, Ohio, 43210
- Recruiting
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Germany5 sites, 3 recruiting
- Recruiting
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
- Completed
Marien Hospital Duesseldorf
Düsseldorf, 40479
- Recruiting
Klinik fur Innere Medizin IV - Hamatologie/Onkologie, Universitatsklinikum Hall
Halle, 07747
- Recruiting
Universitaetsklinikum Jena
Jena, 07743
- Completed
Praxisklinik fur Hamatologie und Onkologie
Koblenz, 56073
Spain5 sites, 4 recruiting
- Recruiting
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908
- Recruiting
Hospital Germans Trias i Pujol
Barcelona, 08916
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Completed
Salamanca University Hospital
Salamanca, 37007
- Recruiting
Hospital Quirónsalud Zaragoza
Zaragoza, 50006
Australia4 sites, 2 recruiting
- Completed
Border Medical Oncology
East Albury
- Completed
Southern Oncology Specialists
Kogarah, 2217
- Recruiting
Royal Perth Hospital
Perth, 6000
- Recruiting
St Vincent's Hospital Sydney
Sydney, 2010
Hungary4 sites
- Completed
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
- Completed
Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, 3300
- Completed
Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktatókórház Megyei-Városi Tüdőgondozó Intézete
Nyíregyháza, 4400
- Completed
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
Poland4 sites, 2 recruiting
- Active, not recruiting
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Klinika Hematologi
Bydgoszcz, 85-168
- Active, not recruiting
Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii
Gdansk, 80-211
- Not yet recruiting
Klinika Hematologii Collegium Medicum Uniwersytetu Jagiellonskiego
Krakow, 31-501
- Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
Wroclaw, 52-007
Taiwan4 sites
- Active, not recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, 80756
- Completed
Chang Gung Memorial Hospital - Kaohsiung Branch
Kaohsiung City
- Completed
China Medical University Hospital
Taichung, 404
- Completed
National Taiwan University Hospital
Taipei
France3 sites
- Active, not recruiting
CH Le Mans
Le Mans, 72037
- Completed
CHU de Nantes - Hôtel-Dieu
Nantes, 44000
- Completed
CHU de Nice - Hopital L' Archet II
Nice, 06200
South Korea3 sites
- Completed
Kyungpook National University Hospital
Daegu
- Completed
Seoul National University Hospital
Seoul
- Completed
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul
Belgium2 sites, 1 recruiting
- Recruiting
Chu De Liège
Liège, 4000
- Active, not recruiting
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, 1200
Bulgaria2 sites
- Completed
University Hospital "St Ivan Rilski"
Sofia, 1431
- Active, not recruiting
Military Medical Academy
Sofia
Brazil1 site
- Completed
Instituto de Estudos e Pesquisas Sao Lucas - IEP - Sao Lucas
São Paulo, 76805
About this study
Official title: A Phase 2 Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
- Conditions
- Myelofibrosis, Indolent Systemic Mastocytosis
- Being tested
- TL-895, Placebo
- Medical subject headings
- Primary Myelofibrosis, Mastocytosis, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TL-895Drug
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.
PlaceboDrug
Placebo to match TL-895
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a, Relapsed/Refractory Myelofibrosis | Experimental | 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. Receives: Drug: TL-895 |
| Cohort 1b, Relapsed/Refractory Myelofibrosis | Experimental | 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. Receives: Drug: TL-895 |
| Cohort 1c, Relapsed/Refractory Myelofibrosis | Experimental | 300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. Receives: Drug: TL-895 |
| Cohort 1d, Relapsed/Refractory Myelofibrosis | Experimental | 450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. Receives: Drug: TL-895 |
| Cohort 2a, JAKi Intolerant Myelofibrosis | Experimental | 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. Receives: Drug: TL-895 |
| Cohort 2b, JAKi Intolerant Myelofibrosis | Experimental | 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. Receives: Drug: TL-895 |
| Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L | Experimental | 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. Receives: Drug: TL-895 |
| Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L | Experimental | 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. Receives: Drug: TL-895 |
| Cohort 5a, Indolent Systemic Mastocytosis | Experimental | TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with best supportive care (BSC). Receives: Drug: TL-895 |
| Cohort 5b, Indolent Systemic Mastocytosis | Experimental | TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC. Receives: Drug: TL-895 |
| Cohort 5c, Indolent Systemic Mastocytosis | Experimental | TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC. Receives: Drug: TL-895 |
| Cohort 5d, Indolent Systemic Mastocytosis | Experimental | TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC. Receives: Drug: TL-895 |
| Cohort 5e, Indolent Systemic Mastocytosis | Placebo comparator | Placebo to match TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts 1-3: Determine the RP2D of TL-895
The RP2D for Cohorts 1, 2 and 3 will be reported
Measured: 9 months
Cohort 5: Determine the RP2D of TL-895
The RP2D for Cohort 5 will be reported
Measured: Week 24
Secondary outcomes (2)
Cohorts 1-3: Spleen volume reduction (SVR) rate
The proportion of subjects achieving ≥35% SVR at Week 24 by MRI or CT scan (central review).
Measured: Week 24
Cohort 5: Changes in patient reported symptoms
Mean change in patient reported symptom assessment
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start22 Oct 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telios Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655118
- Sponsor's protocol ID
- TL-895-201
- Status last verified
- May 2024
- First submitted
- 24 Nov 2020
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter Study of TL-895 in Subjects With Relapsed/Refractory Myelofibrosis, Janus Kinase Inhibitor Intolerant Myelofibrosis, Janus Kinase Inhibitor Treatment Ineligible Myelofibrosis, or Indolent Systemic Mastocytosis
- ClinicalTrials.gov ID
- NCT04655118
- Acronym / sponsor ID
- TL-895-201
- Conditions
- Myelofibrosis, Indolent Systemic Mastocytosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Telios Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a, Relapsed/Refractory Myelofibrosis | Experimental | Drug: TL-895150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. |
| Cohort 1b, Relapsed/Refractory Myelofibrosis | Experimental | Drug: TL-895300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. |
| Cohort 1c, Relapsed/Refractory Myelofibrosis | Experimental | Drug: TL-895300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. |
| Cohort 1d, Relapsed/Refractory Myelofibrosis | Experimental | Drug: TL-895450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. |
| Cohort 2a, JAKi Intolerant Myelofibrosis | Experimental | Drug: TL-895150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. |
| Cohort 2b, JAKi Intolerant Myelofibrosis | Experimental | Drug: TL-895300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. |
| Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L | Experimental | Drug: TL-895150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle. |
| Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L | Experimental | Drug: TL-895300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle. |
| Cohort 5a, Indolent Systemic Mastocytosis | Experimental | Drug: TL-895TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with best supportive care (BSC). |
| Cohort 5b, Indolent Systemic Mastocytosis | Experimental | Drug: TL-895TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC. |
| Cohort 5c, Indolent Systemic Mastocytosis | Experimental | Drug: TL-895TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC. |
| Cohort 5d, Indolent Systemic Mastocytosis | Experimental | Drug: TL-895TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC. |
| Cohort 5e, Indolent Systemic Mastocytosis | Placebo comparator | Drug: PlaceboPlacebo to match TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults ≥18 years of age
- Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- Adequate hematologic, hepatic, and renal functions
- MF symptoms as defined by having at least 2 symptoms with an average baseline (Day -7 to Day -1) score of at least 1 for each of the 2 symptoms per MFSAF v4.0
Key exclusion criteria (7 listed)
- Prior treatment with any BTK or BMX inhibitors
- Prior treatment with JAKi within 28 days prior to study treatment
- Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment
- Cohort 5
- Prior treatment with any BTK or BMX inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TL-895TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth. | Drug | Cohort 1a, Relapsed/Refractory Myelofibrosis, Cohort 1b, Relapsed/Refractory Myelofibrosis, Cohort 1c, Relapsed/Refractory Myelofibrosis, Cohort 1d, Relapsed/Refractory Myelofibrosis, Cohort 2a, JAKi Intolerant Myelofibrosis, Cohort 2b, JAKi Intolerant Myelofibrosis, Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L, Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of ≥ 25 and < 50 × 109/L, Cohort 5a, Indolent Systemic Mastocytosis, Cohort 5b, Indolent Systemic Mastocytosis, Cohort 5c, Indolent Systemic Mastocytosis, Cohort 5d, Indolent Systemic Mastocytosis |
| PlaceboPlacebo to match TL-895 | Drug | Cohort 5e, Indolent Systemic Mastocytosis |
Primary outcome
Cohorts 1-3: Determine the RP2D of TL-895
Time frame: 9 months
The RP2D for Cohorts 1, 2 and 3 will be reported
Cohort 5: Determine the RP2D of TL-895
Time frame: Week 24
The RP2D for Cohort 5 will be reported
2 secondary outcomes
Cohorts 1-3: Spleen volume reduction (SVR) rate
Time frame: Week 24
Cohort 5: Changes in patient reported symptoms
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
52 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TL-895 in people with Myelofibrosis and Indolent Systemic Mastocytosis, run by Telios Pharma, Inc. at 52 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Italy, United States, Germany, Spain, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Mei (650-542-0136, jmei@teliospharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohorts 1-3: Determine the RP2D of TL-895 (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.