Relapsed or refractory classical Hodgkin's lymphoma MedDRA version: 20.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 100000013069
Conditions
Sponsors
LYSARC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients = 18 years with classical HL relapsing or refractory after at least 1 prior systemic therapy. Patients must have relapsed after high-dose therapy with ASCT, or have been deemed ineligible for high-dose therapy with ASCT - ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Previous treatment with ruxolitinib or another JAK inhibitor - Contraindication to ruxolitinib - Patient received chemotherapy or radiotherapy or any investigational drug within 14 days prior to starting study drug or whose side effects of such therapy have not resolved to = grade 1 - Patient treated with allogeneic hematopoietic stem cell transplant who is currently on, or has received immunosuppressive therapy within 90 days prior to start of screening and/or have = Grade 2 graft versus host disease (GvHD). - Patient with prior history of another active primary malignancy = 2 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix - Any serious active disease or co-morbid medical condition that, according to the investigator’s decision, will substantially increase the risk associated with the subject’s participation in the study. - Uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen or presence of anti HBc antibody without detectable anti HBs antibody. - HIV, HCV or HTLV serology positivity and/or documented infection with active hepatitis B - Prior history of CNS involvement with lymphoma - Pregnant or lactating woman - Adult patient unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib measured by overall response rate (ORR) by IWG criteria (Cheson 2007) occurring after 6 months of oral JAK1/2 inhibitor ruxolitinib treatment in patients with advanced HL for whom no treatment with proven efficacy is available;Secondary Objective: - To assess the safety of oral JAK1/2 inhibitor ruxolitinib treatment in Hodgkin Lymphoma - To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib measured by overall response rate (ORR) by IWG criteria (Cheson 2007) occurring after 2 and 4 cycles of oral JAK1/2 inhibitor ruxolitinib treatment - To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib measured by overall response rate (ORR) by IWG criteria (Cheson 1999) occurring after 2, 4 and 6 cycles of oral JAK1/2 inhibitor ruxolitinib treatment - To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib measured by the time to response, the duration of response, progression free survival rates after 6 and 12 months, overall survival according to IWG criteria (Cheson 1999) - To assess the efficacy of oral JAK1/2 inhibitor ruxolitinib on systemic symptoms such as fever, sweating, fatigue, itching;Primary end point(s): The primary efficacy endpoint is to assess the efficacy of oral JAK1/2 inhibitor by measuring the Overall Response Rate using the IWG criteria (International Workshop to Standardize Response criteria for NHL, Cheson 2007). ;Timepoint(s) of evaluation of this end point: Assessment of response will be done after 6 cycles of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints will assess: • the Overall Response Rate (ORR) at 6 cycles according to Cheson 1999 • Complete Response Rate at 2,4 and 6 cycles according to Cheson 2007 • Complete Response Rate at 2,4 and 6 cycles according to Cheson 1999 • Best Response Rate at 6 cycles according to Cheson 2007 • Best Response Rate at 6 cycles according to Cheson 1999 • Time to response • Duration of response • Progression Free Survival (PFS) • Overall Survival (OS) • Evaluation of systemic symptoms (sweating, fever, pruritus/itching, fatigue);Timepoint(s) of evaluation of this end point: • the ORR at 6 cycles • Complete Response Rate at 2,4 and 6 cycles • Complete Response Rate at 2,4 and 6 cycles • Best Response Rate at 6 cycles • Best Response Rate at 6 cycles • Time to response will be assessed from randomization into the study to the time of attainment of PR or CR according to IWG criteria 2007 • Duration of response will be measured from the time of attainment of CR or PR according to IWG criteria 2007 (Cheson 2007) • Progression Free Survival (PFS) will be measured from randomization into the study to the first observation of disease progression/relapse • Overall Survival (OS) will be measured from randomization into the study to the date of death from any cause • Evaluation of systemic symptoms (sweating, fever, pruritus/itching, fatigue) at each cycle | — |
Countries
Belgium
Contacts
Public ContactElise Hutasse - Project Manager
LYSARC
Outcome results
None listed