INCA34176-254: A Phase 2, Open-Label, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease

Conditions

chronic graft-versus-host disease

Brief summary

Overall response (OR) at 6 months, defined for each treatment group as CR or PR at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Criteria

Detailed description

Safety and tolerability will be assessed by evaluating the frequency and severity of AEs (including SAEs) and changes in clinical and laboratory assessments., DOR (in responders only), Proportion of participants with ≥ 7-point improvement in mLSS total score., Best overall response in the first 6 months and on study, based on the 2014 NIH Consensus Criteria, OR at 12 months, defined as CR or PR at 12 months, PK parameters for axatilimab and ruxolitinib, • EFS, defined as the time from the date of randomization to the date of addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (ie, non-CR or non-PR by Month 6), whichever occurs first.

Related papers

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Interventions

DRUGPREDNISONE

DRUGJakavi 5 mg tablets

DRUGAxatilimab (INCA034176)

DRUGMETHYLPREDNISOLONE

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall response (OR) at 6 months, defined for each treatment group as CR or PR at 6 months in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Criteria	—

Secondary

Measure	Time frame
Safety and tolerability will be assessed by evaluating the frequency and severity of AEs (including SAEs) and changes in clinical and laboratory assessments., DOR (in responders only), Proportion of participants with ≥ 7-point improvement in mLSS total score., Best overall response in the first 6 months and on study, based on the 2014 NIH Consensus Criteria, OR at 12 months, defined as CR or PR at 12 months, PK parameters for axatilimab and ruxolitinib, • EFS, defined as the time from the date of randomization to the date of addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (ie, non-CR or non-PR by Month 6), whichever occurs first.	—

Measure

Time frame

Safety and tolerability will be assessed by evaluating the frequency and severity of AEs (including SAEs) and changes in clinical and laboratory assessments., DOR (in responders only), Proportion of participants with ≥ 7-point improvement in mLSS total score., Best overall response in the first 6 months and on study, based on the 2014 NIH Consensus Criteria, OR at 12 months, defined as CR or PR at 12 months, PK parameters for axatilimab and ruxolitinib, • EFS, defined as the time from the date of randomization to the date of addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (ie, non-CR or non-PR by Month 6), whichever occurs first.

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Countries

Belgium, Germany, Italy, Spain

Outcome results

None listed