This trial is active, not recruiting.

Condition hodgkin's lymphoma
Treatment ruxolitinib
Phase phase 2
Targets JAK, JAK1, JAK2
Sponsor The Lymphoma Academic Research Organisation
Collaborator Novartis
Start date July 2013
End date June 2015
Trial size 33 participants
Trial identifier NCT01877005, HIJAK


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.
ruxolitinib JAKAVI

Primary Outcomes

Overall response Rate (ORR) according to Cheson 2007
time frame: 6 months

Secondary Outcomes

Overall response rate (ORR) according to Cheson 1999
time frame: 6 months
Complete response rates (CR) according to Cheson 2007 and 1999
time frame: 2 months, 4 months and 6 months
Best Response Rate (BRR) according to Cheson 1999 and 2007
time frame: 6 months
Safety endpoints
time frame: 30 months
Time to response
time frame: Up to 30 months
Duration of response
time frame: Up to 4.5 years
Progression Free Survival (PFS)
time frame: Up to 4.5 years
Overall Survival (OS)
time frame: Up to 4.5 years
Evaluation of systemic symptoms
time frame: Up to 30 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion critera: - 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 ≤ 3 - Measurable nodal disease: 1 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan cannot be performed). - Patient has the following laboratory values: - Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L [SI units 1.0 x 10^9/L] - Platelet count ≥ 75 x 10^9/L] - Serum creatinine ≤ 1.5 x upper limit of normal (ULN) - Serum bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome) - AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN or ≤ 5.0 x ULN if the transaminase elevation is due to liver disease involvement - Signed written informed consent - Life expectancy ≥ 3 months - Corrected QT interval ≤ 450 mSec - Men and women of childbearing potential must agree to use an adequate method of contraception during the study treatment and for at least 1 week after the last study drug administration - The patient must be covered by a social security system (for inclusions in France) 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.

Additional Information

Official title A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
Principal investigator Eric Van Den Neste, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by The Lymphoma Academic Research Organisation.