Study to obtain preliminary efficacy data of oral JAK1/JAK2 inhibitor INC424 in adult patients with relapsed/refractory classical Hodgkin’s lymphoma
- Conditions
- Relapsed or refractory classical Hodgkin's lymphomaMedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000013069Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2012-004246-15-BE
- Lead Sponsor
- YSARC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
- 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 109/L [SI units 1.0 x 109/L]
• Platelet count = 75 x 109/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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
- 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 & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method