This study employs a 1:1 randomization of patients to receive romidepsin alone verses romidepsin plus pralatrexate for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The primary objectives will be to identify a 75% improvement in progression free survival (PFS) among patients receiving the combination compared to single agent romidepsin.

NCT03355768

Conditions

1. Lymphoma, T-Cell, Peripheral

Interventions

1. Drug: Romidepsin
2. Drug: Pralatrexate

MeSH:Lymphoma Lymphoma, T-Cell, Peripheral Lymphoma, T-Cell

HPO:Lymphoma T-cell lymphoma

There were 3 dose-limiting toxicities (DLTs) in cohort 4 (pralatrexate 20mg/m2 & romidepsin 12mg/m2given weekly x 2 Q21D) consisting of 2 Grade 3 oral mucositis and 1 Grade 4 sepsis. --- Q21D ---

ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex, inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and topotecan) in some xenograft models (ovary, colon, head & neck, cervix). Anti-tumor activity has been also noted in platinum resistant ovarian cell xenografts and in topoisomerase I mutant prostate cell lines. The acceptable toxicity profile in animals and the activity in camptothecin-resistant cell lines make ST1968 a good candidate for clinical trials.

NCT01748019

Conditions

1. Solid Tumors

Interventions

1. Drug: ST1968

MeSH:Neoplasms

HPO:Neoplasm

A starting dose of 1.5mg/m2 given as a flat dose of 2.5mg is defined, given once on Day 1, Day 8 every 21 Days (D1, D8 Q21D schedule), over 2 h. --- Q21D ---

Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule. --- Q21D ---

Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule. --- Q21D --- --- Q21D ---