A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
- Registration Number
- NCT01877005
- Lead Sponsor
- The Lymphoma Academic Research Organisation
- Brief Summary
Phase II study to assess the efficacy of 6 cycles of oral JAK1/2 inhibitor ruxolitinib in patients with advanced Hodgkin's lymphoma for whom no curative option is available.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ruxolitinib Ruxolitinib Induction period: Ruxolitinib will be given twice daily during 6 cycles of 28 days. Maintenance period: patients who achieve at least a stable disease (according Cheson 2007) at the end of cycle 6 and for whose a clinical benefit is observed according to the Investigator's opinion will be eligible for maintenance treatment by ruxolitinib twice daily every day of 28-day cycles.
- Primary Outcome Measures
Name Time Method Overall response Rate (ORR) according to Cheson 2007 6 months Overall Response Rate according to the International Working Group criteria (Cheson 2007) is defined as patient with Complete response or Partial response.
Patient without response assessment (due to whatever reason) will be considered as non responder.
- Secondary Outcome Measures
Name Time Method Overall response rate (ORR) according to Cheson 1999 6 months Overall Response Rate according to the International Working Group criteria (Cheson 1999) is defined as patient with Complete response, unconfirmed Complete response or Partial response.
Patient without response assessment (due to whatever reason) will be considered as non responder.Complete response rates (CR) according to Cheson 2007 and 1999 2 months, 4 months and 6 months Assessment of response will be based on the International Workshop to Standardize Response criteria for lymphoma: Cheson, 1999 and 2007.
Patient without response assessment (due to whatever reason) will be considered as nonresponder.Best Response Rate (BRR) according to Cheson 1999 and 2007 6 months Disease response evaluation at 2; 4 and 6 months will be used to determine the Best Response Rate, according to Cheson 1999 and 2007.
The Best Complete Response and Best Overall Response will be presented. Patient without response assessment (due to whatever reason) will be considered as nonresponder.Safety endpoints 30 months Description of all adverse events, vital signs measurements, clinical laboratory measurements and concomitant medications.
Time to response Up to 30 months Time to response will be defined as the time from inclusion into the study to the time of attainment of PR or CR according to Cheson 2007 criteria.
Duration of response Up to 4.5 years Duration of response will be measured from the time of attainment of CR or PR according to Cheson 2007 cirteria to the date of first documented disease progression, relapse or death from any cause.
Patients alive and free of progression will be censored at their last follow-up date.Progression Free Survival (PFS) Up to 4.5 years PFS is defined at the time from inclusion into the study to the first observation of documented disease progression/relapse according to Cheson 2007 criteria or death due to any cause.
If a subject has not progressed or died, PFS will be censored at the time of last visit.Overall Survival (OS) Up to 4.5 years OS will be measured from the date of inclusion to the date of death from any cause.
Patients who did not died will be censored at the time of last visit.Evaluation of systemic symptoms Up to 30 months Evaluation of efficacy of ruxolitinib on systemic symptoms such as fever, sweating, fatigue and itching will be done via systemic symptoms Questionnaire designed for this purpose and completed at Baseline and then at Day1 of each visit during Induction and Maintenance period of the study
Trial Locations
- Locations (10)
Chu Cote de Nacre
🇫🇷Caen, France
Hopital Henri Mondor
🇫🇷Creteil, France
UCL Louvain St Luc
🇧🇪Brussels, Belgium
Université Catholique de Louvain Mont Godinne
🇧🇪Yvoir, Belgium
Chu Dijon
🇫🇷Dijon, France
Chru de Lille
🇫🇷Lille, France
Centre Leon Berard
🇫🇷Lyon, France
Centre Hospitalier Lyon Sud
🇫🇷Lyon, France
CHU de Nantes, Hotel Dieu
🇫🇷Nantes, France
Centre Henri Becquerel
🇫🇷Rouen, France