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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04655118




Registration number
NCT04655118
Ethics application status
Date submitted
24/11/2020
Date registered
7/12/2020
Date last updated
10/05/2024

Titles & IDs
Public title
Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis
Scientific 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
Secondary ID [1] 0 0
TL-895-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myelofibrosis 0 0
Indolent Systemic Mastocytosis 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Blood 0 0 0 0
Other blood disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TL-895
Treatment: Drugs - Placebo

Experimental: Cohort 1a, Relapsed/Refractory Myelofibrosis - 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

Experimental: Cohort 1b, Relapsed/Refractory Myelofibrosis - 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.

Experimental: Cohort 1c, Relapsed/Refractory Myelofibrosis - 300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

Experimental: Cohort 1d, Relapsed/Refractory Myelofibrosis - 450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

Experimental: Cohort 2a, JAKi Intolerant Myelofibrosis - 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

Experimental: Cohort 2b, JAKi Intolerant Myelofibrosis - 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.

Experimental: Cohort 3a, JAKi Ineligible Myelofibrosis with platelet count of = 25 and < 50 × 109/L - 150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.

Experimental: Cohort 3b, JAKi Ineligible Myelofibrosis with platelet count of = 25 and < 50 × 109/L - 300 mg of TL-895 will be administered orally, once daily (QD) continuously starting on Day 1 in a 28-day cycle.

Experimental: Cohort 5a, Indolent Systemic Mastocytosis - 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).

Experimental: Cohort 5b, Indolent Systemic Mastocytosis - TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.

Experimental: Cohort 5c, Indolent Systemic Mastocytosis - TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.

Experimental: Cohort 5d, Indolent Systemic Mastocytosis - TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle in combination with BSC.

Placebo comparator: Cohort 5e, Indolent Systemic Mastocytosis - 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.


Treatment: Drugs: TL-895
TL-895 is an experimental tyrosine kinase inhibitor drug taken by mouth.

Treatment: Drugs: Placebo
Placebo to match TL-895

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cohorts 1-3: Determine the RP2D of TL-895
Timepoint [1] 0 0
9 months
Primary outcome [2] 0 0
Cohort 5: Determine the RP2D of TL-895
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Cohorts 1-3: Spleen volume reduction (SVR) rate
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Cohort 5: Changes in patient reported symptoms
Timepoint [2] 0 0
Week 12

Eligibility
Key inclusion criteria
Cohorts 1-3

Key

* 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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Key Inclusion Criteria:

* 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

Key

* Prior treatment with any BTK or BMX inhibitors
* Prior treatment with Avapritinib, bezuclastinib, or BLU-263/elenestinib
* Diagnosis with another myeloproliferative disorder

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Border Medical Oncology - East Albury
Recruitment hospital [2] 0 0
Southern Oncology Specialists - Kogarah
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment postcode(s) [1] 0 0
- East Albury
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Ohio
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Belgium
State/province [5] 0 0
Liège
Country [6] 0 0
Belgium
State/province [6] 0 0
Woluwe-Saint-Lambert
Country [7] 0 0
Brazil
State/province [7] 0 0
São Paulo
Country [8] 0 0
Bulgaria
State/province [8] 0 0
Sofia
Country [9] 0 0
France
State/province [9] 0 0
Le Mans
Country [10] 0 0
France
State/province [10] 0 0
Nantes
Country [11] 0 0
France
State/province [11] 0 0
Nice
Country [12] 0 0
Germany
State/province [12] 0 0
Dresden
Country [13] 0 0
Germany
State/province [13] 0 0
Düsseldorf
Country [14] 0 0
Germany
State/province [14] 0 0
Halle
Country [15] 0 0
Germany
State/province [15] 0 0
Jena
Country [16] 0 0
Germany
State/province [16] 0 0
Koblenz
Country [17] 0 0
Hungary
State/province [17] 0 0
Debrecen
Country [18] 0 0
Hungary
State/province [18] 0 0
Eger
Country [19] 0 0
Hungary
State/province [19] 0 0
Nyíregyháza
Country [20] 0 0
Hungary
State/province [20] 0 0
Székesfehérvár
Country [21] 0 0
Italy
State/province [21] 0 0
Catania
Country [22] 0 0
Italy
State/province [22] 0 0
Meldola
Country [23] 0 0
Italy
State/province [23] 0 0
Milano
Country [24] 0 0
Italy
State/province [24] 0 0
Novara
Country [25] 0 0
Italy
State/province [25] 0 0
Perugia
Country [26] 0 0
Italy
State/province [26] 0 0
Ravenna
Country [27] 0 0
Italy
State/province [27] 0 0
Reggio Calabria
Country [28] 0 0
Italy
State/province [28] 0 0
Roma
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Daegu
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Seoul
Country [31] 0 0
Poland
State/province [31] 0 0
Bydgoszcz
Country [32] 0 0
Poland
State/province [32] 0 0
Gdansk
Country [33] 0 0
Poland
State/province [33] 0 0
Kraków
Country [34] 0 0
Poland
State/province [34] 0 0
Wroclaw
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Salamanca
Country [38] 0 0
Spain
State/province [38] 0 0
Zaragoza
Country [39] 0 0
Taiwan
State/province [39] 0 0
Kaohsiung City
Country [40] 0 0
Taiwan
State/province [40] 0 0
Kaohsiung
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taichung
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Telios Pharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
John Mei
Address 0 0
Country 0 0
Phone 0 0
650-542-0136
Fax 0 0
Email 0 0
jmei@teliospharma.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.