Hodgkin's Lymphoma
Conditions
Keywords
Hodgkin's Lymphoma, HDAC, 4SC-201, Resminostat, Phase II
Brief summary
The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
Interventions
DRUGResminostat (4SC-201)
oral administration
Sponsors
4SC AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Patients must have histological or cytological evidence of Hodgkin's Lymphoma (all subtypes are acceptable) * Patients must have relapsed or refractory Hodgkin's Lymphoma (HL) defined as relapse following initial therapy or lack of response to first line therapy and treatment with second-line (salvage therapy). Patients may have also undergone high-dose chemotherapy with autologous stem cell transplantation at least 12 weeks prior to study entry * Patients must have measurable anatomical disease present on CT scan * Patients must have an ECOG Performance Score of 0, 1 or 2 Main
Exclusion criteria
* Patients who have received previous treatment with an HDAC inhibitor * Patients who have undergone allogeneic hematopoietic stem cell transplantation * Patients with known or suspected involvement of the CNS by HL * Patients treated with agents known to prolong the QT interval or with a confirmed QTcF \> 450 msec * Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current PSA \< 0.1 ng/ml; or cervical intraepithelial neoplasia * Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the trial, pose an undue medical hazard or interfere with the interpretation of the trial results, including, but not limited to, patients with congestive heart failure (NYHA Class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring \> 2 medications for adequate control; diabetes mellitus with \> 2 episodes of ketoacidosis in the preceding 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determination of the best overall objective response rate (ORR) based on IWG criteria of Resminostat (4SC-201) in patients with refractory or relapsed Hodgkin's Lymphoma. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the overall survival (OS) | 12 weeks |
| Determination of progression free survival (PFS), including radiological and symptomatic progression | 12 weeks |
| Investigation of the safety and tolerability of repeated oral doses of Resminostat (4SC-201) | 12 weeks |
| Determination of duration of response (DOR) | 12 weeks |
| Assessment of the pharmacokinetics of Resminostat (4SC-201) after oral dosing | 12 weeks |
| Determination of time to progression (TTP), including objective and symptomatic progression | 12 weeks |
Countries
Czechia, Poland, Romania
Outcome results
None listed