Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT01877005
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01877005
Study Brief:
Protocol Section:
NCT01877005