Status:
COMPLETED
A Phase II Study of Oral JAK1/JAK2 Inhibitor INC424 in Adult Patients With Relapsed/Refractory Classical Hodgkin's Lymphoma
Lead Sponsor:
The Lymphoma Academic Research Organisation
Collaborating Sponsors:
Novartis
Conditions:
Hodgkin's Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 4 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2018
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01877005
Start Date
July 4 2013
End Date
June 12 2018
Last Update
August 22 2018
Active Locations (10)
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1
UCL Louvain St Luc
Brussels, Belgium, 10200
2
Université Catholique de Louvain Mont Godinne
Yvoir, Belgium, 5530
3
Chu Cote de Nacre
Caen, France, 14000
4
Hopital Henri Mondor
Créteil, France, 94010