A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
HIJAK
1 other identifier
interventional
33
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2013
Longer than P75 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2013
CompletedFirst Posted
Study publicly available on registry
June 13, 2013
CompletedStudy Start
First participant enrolled
July 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2018
CompletedAugust 22, 2018
August 1, 2018
1.9 years
June 11, 2013
August 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Other Outcomes (1)
Anatomopahtological study
baseline
Study Arms (1)
Ruxolitinib
EXPERIMENTALInduction 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.
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Lymphoma Academic Research Organisationlead
- Novartiscollaborator
Study Sites (10)
UCL Louvain St Luc
Brussels, 10200, Belgium
Université Catholique de Louvain Mont Godinne
Yvoir, 5530, Belgium
Chu Cote de Nacre
Caen, 14000, France
Hopital Henri Mondor
Créteil, 94010, France
Chu Dijon
Dijon, 21000, France
Chru de Lille
Lille, 59037, France
Centre Leon Berard
Lyon, 69373, France
Centre Hospitalier Lyon Sud
Lyon, 69495, France
CHU de Nantes, Hotel Dieu
Nantes, 44093, France
Centre Henri Becquerel
Rouen, 76038, France
Related Publications (1)
Van Den Neste E, Andre M, Gastinne T, Stamatoullas A, Haioun C, Belhabri A, Reman O, Casasnovas O, Ghesquieres H, Verhoef G, Claessen MJ, Poirel HA, Copin MC, Dubois R, Vandenberghe P, Stoian IA, Cottereau AS, Bailly S, Knoops L, Morschhauser F. A phase II study of the oral JAK1/JAK2 inhibitor ruxolitinib in advanced relapsed/refractory Hodgkin lymphoma. Haematologica. 2018 May;103(5):840-848. doi: 10.3324/haematol.2017.180554. Epub 2018 Jan 19.
PMID: 29351986DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Van Den Neste, MD
Lymphoma Study Association
- PRINCIPAL INVESTIGATOR
Franck Morschhauser, MD
Lymphoma Study Association
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2013
First Posted
June 13, 2013
Study Start
July 4, 2013
Primary Completion
June 1, 2015
Study Completion
June 12, 2018
Last Updated
August 22, 2018
Record last verified: 2018-08