This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
426
Administered intravenous (IV) in accordance with the protocol-defined requirements.
Best Available Therapy (BAT) will be selected by the investigator.
Durable clinicohematologic response (DCR)
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Time frame: Week 24
Reduction from baseline in calreticulin exon 9 frameshift mutation(s) (mutCLAR) variant allele frequency (VAF)
Reduction in mutCALR VAF as defined in the protocol.
Time frame: Week 24
Durable clinicohematologic response (DCR)
Normalization of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Time frame: Week 48
Durable partial clinicohematologic response (DPR)
Improvement of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Time frame: Week 24
Durable partial clinicohematologic response (DPR)
Improvement of platelet and white blood cell (WBC) counts and absence of disease progression as defined in the protocol.
Time frame: Week 48
Longest duration of complete hematologic response (CHR)
Longest time from documented CHR until the loss of CHR as defined in the protocol.
Time frame: Up to Week 48
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Defined as any adverse event occurring after the first dose of study drug until up to 60 days after the last dose of study drug.
Time frame: Up to Week 48 and 60 days after last dose
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Banner Md Anderson Cancer Center
Gilbert, Arizona, United States
NOT_YET_RECRUITINGCity of Hope Medical Center
Duarte, California, United States
NOT_YET_RECRUITINGMarin Cancer Care
Greenbrae, California, United States
RECRUITINGUniversity of California, Los Angeles Medical Center
Los Angeles, California, United States
NOT_YET_RECRUITINGStanford Cancer Center
Palo Alto, California, United States
NOT_YET_RECRUITINGRocky Mountain Cancer Centers-Lone Tree
Lone Tree, Colorado, United States
NOT_YET_RECRUITINGMedstar Georgetown Medical Center, Inc
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITINGFlorida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
NOT_YET_RECRUITINGUniversity of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
NOT_YET_RECRUITINGCleveland Clinic
Weston, Florida, United States
NOT_YET_RECRUITING...and 165 more locations
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.
Time frame: Up to Week 48 and 60 days after last dose
Number of participants with a reduction in mutCALR VAF
Number of participants with a reduction in mutCALR VAF as defined in the protocol.
Time frame: Week 24 and Week 48
Molecular response
Overall reduction in mutCALR VAF as defined in the protocol.
Time frame: Week 24 and Week 48
Change from baseline in Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) total symptom score (TSS)
Defined as the proportion of participants who achieve a protocol defined reduction in TSS.
Time frame: Up to Week 48
Change from baseline in Brief Fatigue Inventory (BFI) fatigue score
The BFI is a 9 item scored from 0 (no fatigue) -10 (as bad as you can imagine), items are averaged with total score from 0-10, with higher score indicating more fatigue.
Time frame: Up to Week 48
Patient Global Impression of Change (PGIC) score
The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.
Time frame: Up to Week 48