GVHD
A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
Incyte Study ID:
INCA34176-254
CT.gov ID:
Eudra ID:
N/A
EU CT Number:
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Oct 2024 - Dec 2029
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
12 Years - NA
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
AZ SINT-JAN BRUGGE - OOSTENDE AV - CAMPUS SINT-JAN
BRUGGE, Belgium, 08000
Status
Recruiting
Name
UNIVERSITAIRE ZIEKENHUIS LEUVEN - GASTHUISBERG
LEUVEN, Belgium, 03000
Status
Recruiting
Name
AZ DELTA
ROESELARE, Belgium, 08800
Status
Recruiting
Name
CENTRE HOSPITALIER UNIVERSITAIRE (CHU) DE LIEGE
LIEGE, Belgium, 04000
Status
Recruiting
Name
JESSA ZIEKENHUIS
HASSELT, Belgium, 03500
Status
Recruiting
Name
PRINCESS MARGARET CANCER CENTRE - UNIVERSITY HEALTH NETWORK
TORONTO, ON, Canada, M5G 2M9
Status
Recruiting
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Key Inclusion and Exclusion Criteria
Inclusion Criteria
- ≥ 12 years of age at the time of informed consent.
- New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
Exclusion Criteria
- Received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
- Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
Requirements information
Inclusion Criteria
- • ≥ 12 years of age at the time of informed consent.
- • New-onset moderate or severe cGVHD, as defined by the 2014 NIH Consensus Development Project Criteria for Clinical Trials in cGVHD, requiring systemic therapy.
- • History of 1 allo-SCT (any type of stem cell donor, any conditioning regimen, and source of hematopoietic stem cells).
- • Adequate hematologic function independent of platelet transfusion and growth factors for at least 7 days prior to study entry: ANC ≥ 0.75 × 109/L and platelet count ≥ 20 × 109/L.
- • Willingness to avoid pregnancy or fathering children.
Exclusion Criteria
- • Received more than 1 prior allo-SCT. Prior autologous HCT is allowed.
- • Has overlap cGVHD, defined as simultaneous presence of features or characteristics of aGVHD in a patient with cGVHD.
- • Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis.
- • Received systemic corticosteroids within 2 weeks prior to C1D1, regardless of indication.
- • Initiated systemic treatment with CNIs or mTOR inhibitors within 2 weeks prior to C1D1.
- • Prior treatment with a JAK inhibitor within 8 weeks before randomization. Participants who received a JAK inhibitor for the treatment of aGVHD are eligible only if they achieved a response (CR or PR) to JAK inhibitor treatment and did not discontinue due to toxicity.
- • Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse.
- • History of acute or chronic pancreatitis.
- • History of thromboembolic events (such as deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction) in the 6 months prior to study entry.
- • Active symptomatic myositis.
- • Severe renal impairment, that is, estimated CrCl < 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage renal disease on dialysis. Participants with CrCl of 30 to 59 mL/min on treatment with fluconazole are not eligible.
- • Impaired liver function, defined as total bilirubin > 1.5 × ULN and/or ALT and AST > 3 × ULN in participants with no evidence of liver cGVHD.
- • Currently active significant cardiac disease, such as uncontrolled arrhythmias, uncontrolled hypertension, or Class 3 or 4 congestive heart failure as defined by New York Heart Association, or a history of myocardial infarction or unstable angina within 6 months prior to randomization.
- • Pregnant or breastfeeding.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Protocol Summary
Incyte Study ID:
INCA34176-254
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
None (Open Label)
Interventions:
Enrollment:
120
Primary Outcome
Open
Objective Response Rate
Timeframe: 6 months
Secondary Outcome
Open
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 2 years and 30 days
Duration of Response
Timeframe: Up to 2 years
Proportion of participants with a ≥ 7-point improvement in modified Lee symptom scale (mLSS) score
Timeframe: Up to 2 years
Best overall response in the first 6 months
Timeframe: 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.
Timeframe: 12 months
Proportion of participants who remain corticosteroid-free
Timeframe: 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.
Timeframe: Up to 2 years
Failure-free Survival (FFS)
Timeframe: Up to 2 years and 30 days
Axatilimab pharmacokinetic (PK) in Plasma
Timeframe: Up to 2 years and 30 days
Ruxolitinib PK in Plasma
Timeframe: Up to 2 years and 30 days