Phase II of Lenalidomide After Salvage Therapy in R/R Non-Hodgkin T-cell Lymphoma (NCT03730740) | Clinical Trial Compass
UnknownPhase 2
Phase II of Lenalidomide After Salvage Therapy in R/R Non-Hodgkin T-cell Lymphoma
South Korea79 participantsStarted 2018-11-16
Plain-language summary
This study is to evaluate the efficacy and safety of lenalidomide maintenance therapy in patients with T-cell lymphoma who have undergone more than one treatment or relapsed after treatment and who acquired a response of more than a partial response after rescue chemotherapy. This is a phase 2 clinical trial.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. The following subtypes of T-cell lymphoma histologically diagnosed based on WHO classification:
✓. Relapse or progression after one or more previous therapies.
✓. Partial response or more to a salvage therapy and at least 4 cycles of that salvage therapy at the time of participation in the clinical study.
✓. Where autologous stem cell transplantation is unattainable due to poor physical conditions over 65 years of age or secondary transplantation is unattainable due to relapse after primary autologous stem cell transplantation.
✓. Non-pregnant female patients who satisfy the following:
✓. Male patients who can satisfy the following even if they are surgically infertile (with vasectomy):
✓. 0 - 2 points in performance ability based on the classification of the eastern Cooperative Oncology Group (ECOG).
✓. Appropriate condition of bone marrow, kidney, and liver.
Exclusion criteria
✕. Anyone classified into a histological subtype outside the selection criteria;
✕. When autologous or allogenic stem cell transplantation is planned after salvage therapy;
✕. Patients with symptomatic or uncontrolled angina pectoris or congestive heart failure, arrhythmia requiring chemotherapy, or major hazards anticipated due to clinically significant myocardial infarction that occurred 6 months in prior to participating in this clinical test;
✕. In case of an infection exceeding Grade 2 under Common Terminology Criteria for Adverse Events, Version 4.03;
✕. Anyone with an accompanied disease that is severe and uncontrolled;
✕. Anyone with uncontrolled active Type B or C hepatitis (excluding healthy Type B hepatitis carriers who can be controlled by preventive antiviral agents);
✕. Anyone infected with human immunodeficiency virus (HIV);
✕. Anyone with allogenic organ transplantation or allogenic stem cell transplantation;