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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
UCL Louvain St Luc
Brussels, Belgium
Université Catholique de Louvain Mont Godinne
Yvoir, Belgium
Chu Cote de Nacre
Caen, France
Hopital Henri Mondor
Créteil, France
Overall response Rate (ORR) according to Cheson 2007
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.
Time frame: 6 months
Overall response rate (ORR) according to Cheson 1999
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.
Time frame: 6 months
Complete response rates (CR) according to Cheson 2007 and 1999
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.
Time frame: 2 months, 4 months and 6 months
Best Response Rate (BRR) according to Cheson 1999 and 2007
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.
Time frame: 6 months
Safety endpoints
Description of all adverse events, vital signs measurements, clinical laboratory measurements and concomitant medications.
Time frame: 30 months
Time to response
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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
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.
Time frame: Up to 30 months
Duration of response
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.
Time frame: Up to 4.5 years
Progression Free Survival (PFS)
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.
Time frame: Up to 4.5 years
Overall Survival (OS)
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.
Time frame: Up to 4.5 years
Evaluation of systemic symptoms
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
Time frame: Up to 30 months