IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV)
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|ClinicalTrials.gov Identifier: NCT04262141|
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : October 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Essential Thrombocythemia Polycythemia Vera||Drug: IMG-7289||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigator-Initiated Trial of the LSD1 Inhibitor IMG-7289 for the Treatment of Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) That Have Failed at Least One Standard Therapy|
|Actual Study Start Date :||October 2, 2020|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Experimental: IMG-7289 in ET and PV Patients
Oral daily dose of 0.6 mg/kg/day IMG-7289 will be administered:
Daily oral dose of 0.6 mg/kg/day IMG-7829 capsules. Dose escalation an de-escalation rules applied as necessary.
- Hematologic Response Rates [ Time Frame: 24 Weeks ]As evaluated by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) and European Leukemia Net (ELN) response criteria.
- Incidence of Treatment-Related Toxicity [ Time Frame: Up to 3 Years ]As evaluated by the treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
- Change in Total Symptom Score (TSS) as Measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) [ Time Frame: Baseline, Up to 3 Years ]As measured using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) that includes 14 disease related symptoms each scored from 0 (absent) to 10 (worst imaginable).
- Change in Mutational Allele Burden [ Time Frame: Baseline, Up to 3 Years ]Evaluated via Next Generation Sequencing (NGS) molecular profiling from serum blood sample.
- Change in Spleen Size in Centimeters [ Time Frame: Baseline, Up to 3 Years ]Measured via physical examination and radiologic imaging measurement.
- Change in Fibrosis Score [ Time Frame: Baseline, Up to 3 Years ]Assessed using a slightly modified version of European Consensus Criteria for Grading Myelofibrosis from bone marrow/aspirate sample, as presented in Thiele et al, 2005. Myelofibrosis (MF) scores are graded on a four-point scale, from MF-0 to MF-3, grading the reticulin and collagen content of bone marrow, with MF-0 being the lowest and MF-3 the highest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262141
|Contact: Terrence J Bradley, MDemail@example.com|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Terrence J Bradley, MD firstname.lastname@example.org|
|Principal Investigator: Terrence J Bradley, MD|
|Principal Investigator:||Terrence J Bradley, MD||University of Miami|