A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab (INCA034176) and Corticosteroids as Initial Treatment for Chronic Graft-Versus Host Disease

Conditions

chronic graft-versus-host disease

Brief summary

EFS, defined as the time from the date of randomization to the date of the first EFS event. Events are defined as addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (non-CR or non-PR by Month 6).

Detailed description

OR at 6 months, defined for each treatment group as CR or PR at 6 months (C7D1) in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (refined NIH response algorithm for cGVHD disease in joints and fascia [Inamoto et al 2020])., Response, defined as the proportion of participants with a ≥ 7-point improvement in mLSS total score., EFS2, defined as the time from the date of randomization to the date of the first EFS event. Events are defined as date of progression based on best prior organ status (nadir in score level), addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (non-CR or non-PR by Month 6).

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMETHYLPREDNISOLONE

DRUGAxatilimab (INCA034176)

DRUGPREDNISONE

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
EFS, defined as the time from the date of randomization to the date of the first EFS event. Events are defined as addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (non-CR or non-PR by Month 6).	—

Secondary

Measure	Time frame
OR at 6 months, defined for each treatment group as CR or PR at 6 months (C7D1) in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (refined NIH response algorithm for cGVHD disease in joints and fascia [Inamoto et al 2020])., Response, defined as the proportion of participants with a ≥ 7-point improvement in mLSS total score., EFS2, defined as the time from the date of randomization to the date of the first EFS event. Events are defined as date of progression based on best prior organ status (nadir in score level), addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (non-CR or non-PR by Month 6).	—

Measure

Time frame

OR at 6 months, defined for each treatment group as CR or PR at 6 months (C7D1) in the absence of new systemic therapy for cGVHD. Response assessment will be based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD (refined NIH response algorithm for cGVHD disease in joints and fascia [Inamoto et al 2020])., Response, defined as the proportion of participants with a ≥ 7-point improvement in mLSS total score., EFS2, defined as the time from the date of randomization to the date of the first EFS event. Events are defined as date of progression based on best prior organ status (nadir in score level), addition or initiation of new systemic therapy for cGVHD, death due to any cause, or Day 1 in the case of treatment failure (non-CR or non-PR by Month 6).

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Countries

Austria, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain

Outcome results

None listed