A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft vs host disease after allogeneic stem cell transplantation (REACH 3) (CINC424D2301)
- Conditions
- Graft versus host disease na stamcel transplantatieGraft vs host disease
- Registration Number
- NL-OMON50350
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
•Female and male patients >= 12 years old.
•Having undergone allogenic stem cell transplantation, see protocol section 5
for details.
•Absolute neutrophil count > 1000/mm3 and platelet count > 25,000/ mm3.
•Patients with clinically diagnosed cGvHD staging of moderate to severe
according to NIH Consensus Criteria, see protocolsection 5 for details.
•Currently receiving systemic or topical corticosteroids for the treatment of
cGvHD for a duration of < 12 months prior to Cycle 1 Day 1, and have a
confirmed diagnosis of corticosteroid refractory cGvHD defined per 2014 NIH
consensus criteria irrespective of the concomitant use of a calcineurin
inhibitor (CNI), see protocol section 5 for details.
•ECOG performance status 0-1-2 or Lansky performance score 60-100%.
•Patient must accept to be treated with only one of the following BAT (best
available therapy) options. Additions and changes are allowed during the course
of the study, but only with BAT from the following options: extracorporeal
photopheresis, low-dose methotrexate, mycophenolate mofetil, everolimus or
sirolimus, infliximab, rituximab, pentostatin, imatinib or ibrtinib.
Concomitant use of CNI and steroids is allowed.
•Having received 2 or more systemic treatment for cGvHD in addition to
corticosteroids ± CNI for cGvHD.
•Overlap syndrome, see protocol section 5 for details.
•Treated with prior JAK inhibitors for acute GvHD, see protocol section 5 for
exceptions.
•Failed prior allogenic stem cell transplantation within the past 6 months.
•Relapsed primary malignancy, or who having been treated for relapse after the
allogenic stem cell transplantation was performed.
•History of progressive multifocal leuko-encephalopathy.
•Active uncontrolled bacterial, fungal, parasitic, or viral infection, see
protocol section 5 for details.
•Mechanical ventilation or resting O2 saturation <90%.
•Any corticosteroid therapy for indications other than cGvHD at doses >1
mg/kg/day methylprednisolone or equivalent within 7 days of Cycle 1 Day 1.
•Treatment with medications that interfere with coagulation or platelet
function, see protocol section 5 for details.
•Pregnancy, lactation, insufficient contraception for females of childbearing
potential, see protocol section 5 for details.
•For male patients randomized to BAT: Sexually active males, unless they use a
condom during intercourse, see protocol section 5 for details.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Overall response rate</p><br>
- Secondary Outcome Measures
Name Time Method <p>Failure free survival, change in modified Lee cGvHD Symptom Scale score. Best<br /><br>overall response, duration of response, overall survival, non-relapse<br /><br>mortality, proportion of patients with >=50% reduction in the daily steroid dose<br /><br>at Cycle 7 Day 1, proportion of patients who successfully tapered off all<br /><br>steroids at Cycle 7 Day 1. Cumulative incidence of Malignancy<br /><br>Relapse/Recurrence. Change in FACT-BMT and EQ-5D. PK of ruxolitinib. Safety and<br /><br>tolerability of ruxolitinib and BAT. Medical resource utilization.</p><br>