This study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Axatilimab will be administered at protocol defined dose.
Ruxolitinib will be administered at protocol defined dose.
Corticosteroids will be administered at protocol defined dose.
Objective Response Rate
Defined as Complete Response (CR) or Partial Response (PR) at 6 months 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.
Time frame: 6 months
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment.
Time frame: Up to 2 years and 30 days
Duration of Response
Defined as the time from the first response (PR or CR) to the date of progression of cGVHD, start of new systemic therapy or death from any cause.
Time frame: Up to 2 years
Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score
Time frame: Up to 2 years
Best overall response in the first 6 months
Define as PR or CR in the first 6 months.
Time frame: Up to 6 months
OR at 12 months, defined as CR or PR at 12 months (C14D1) in the absence of new systemic therapy for cGVHD.
Defined as CR or PR at 12 months in the absence of new systemic therapy for cGVHD
Time frame: 12 months
Proportion of participants who remain corticosteroid-free
Time frame: 4 weeks, 8 weeks and 6 months
Organ-specific response in the first 6 cycles and on study, based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mayo Clinic Hospital
Phoenix, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
University of California-Los Angeles Medl Cntr-Oncology Center Bowyer Clinic
Los Angeles, California, United States
Stanford Cancer Center
Stanford, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Smilow Cancer Center-Yale
New Haven, Connecticut, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Northwestern University
Chicago, Illinois, United States
The University of Chicago Medicine
Chicago, Illinois, United States
...and 58 more locations
Based on the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD.
Time frame: Up to 2 years
Failure-free Survival (FFS)
Defined as the time from date of randomization to date of initiation of a new cGVHD treatment, malignancy relapse, or death due to any cause.
Time frame: Up to 2 years and 30 days
Axatilimab pharmacokinetic (PK) in Plasma
Axatilimab concentration in plasma.
Time frame: Up to 2 years and 30 days
Ruxolitinib PK in Plasma
Ruxolitinib concentration in plasma.
Time frame: Up to 2 years and 30 days