A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
Overview
- Phase
- Phase 2
- Intervention
- Ruxolitinib
- Conditions
- Hodgkin's Lymphoma
- Sponsor
- The Lymphoma Academic Research Organisation
- Enrollment
- 33
- Locations
- 10
- Primary Endpoint
- Overall response Rate (ORR) according to Cheson 2007
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Ruxolitinib
Outcomes
Primary Outcomes
Overall response Rate (ORR) according to Cheson 2007
Time Frame: 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 Outcomes
- Overall response rate (ORR) according to Cheson 1999(6 months)
- Complete response rates (CR) according to Cheson 2007 and 1999(2 months, 4 months and 6 months)
- Best Response Rate (BRR) according to Cheson 1999 and 2007(6 months)
- Safety endpoints(30 months)
- Time to response(Up to 30 months)
- Duration of response(Up to 4.5 years)
- Progression Free Survival (PFS)(Up to 4.5 years)
- Overall Survival (OS)(Up to 4.5 years)
- Evaluation of systemic symptoms(Up to 30 months)