This clinical trial is for women and men age 18 and older with HTLV-1 associated adult T-cell lymphoma/leukemia (ATLL).
There is no standard of care for ATLL. For patients with aggressive disease, the most promising regimen studied in prospective phase 2 and 3 trials is VCAP-AMP-VECP (also known as LSG15), which includes treatment with vincristine, cyclophosphamide, doxorubicin, prednisone, ranimustine, vindesine, etoposide, and carboplatin. This regimen is associated with significant toxicity. Antiviral therapy (AZT plus interferon) has also been studied in small trials and retrospective analyses, suggesting some benefit.
The primary objective of the study is to investigate the safety and tolerability of multiple subcutaneous or intravenous administration of MRG-106 in subjects with HTLV-1 associated adult T-cell leukemia/lymphoma (ATLL).
A 14-day screening period will be used to determine eligibility. Length of treatment varies. Patients will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.
For Part A: Intratumoral administration of MRG-106
For Part B: MRG-106 administered by various routes
For Part C: MRG-106 as monotherapy