- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01877005
A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma (HIJAK)
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Brussels, Belgium, 10200
- UCL Louvain St Luc
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Yvoir, Belgium, 5530
- Université Catholique de Louvain Mont Godinne
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Caen, France, 14000
- CHU côte de Nacre
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Creteil, France, 94010
- Hopital Henri Mondor
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Dijon, France, 21000
- CHU Dijon
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Lille, France, 59037
- CHRU de Lille
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Lyon, France, 69373
- Centre Léon Bérard
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Lyon, France, 69495
- Centre Hospitalier Lyon Sud
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Nantes, France, 44093
- CHU de Nantes, Hotel Dieu
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Rouen, France, 76038
- Centre Henri Becquerel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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. |
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response Rate (ORR) according to Cheson 2007
Time Frame: 6 months
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR) according to Cheson 1999
Time Frame: 6 months
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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. |
6 months
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Complete response rates (CR) according to Cheson 2007 and 1999
Time Frame: 2 months, 4 months and 6 months
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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. |
2 months, 4 months and 6 months
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Best Response Rate (BRR) according to Cheson 1999 and 2007
Time Frame: 6 months
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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. |
6 months
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Safety endpoints
Time Frame: 30 months
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Description of all adverse events, vital signs measurements, clinical laboratory measurements and concomitant medications.
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30 months
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Time to response
Time Frame: Up to 30 months
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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.
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Up to 30 months
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Duration of response
Time Frame: Up to 4.5 years
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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. |
Up to 4.5 years
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Progression Free Survival (PFS)
Time Frame: Up to 4.5 years
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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. |
Up to 4.5 years
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Overall Survival (OS)
Time Frame: Up to 4.5 years
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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. |
Up to 4.5 years
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Evaluation of systemic symptoms
Time Frame: Up to 30 months
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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
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Up to 30 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Anatomopahtological study
Time Frame: baseline
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baseline
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Franck MORSCHHAUSER, MD, Lymphoma Study Association
- Principal Investigator: Eric Van Den Neste, MD, Lymphoma Study Association
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIJAK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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