Pentamidine + Salvage Chemo for Relapsed/Refractory Classical Hodgkin Lymphoma

Summary

Primary Objective: To evaluate dose limiting toxicity and to determine the recommended phase 2 dose (RP2D) of pentamidine in combination with salvage chemotherapy with ifosfamide, carboplatin and etoposide (ICE) on a 3-weeks schedule in relapsed/refractory classical Hodgkin lymphoma (cHL). Secondary Objective: * To estimate the overall best treatment response at 5- and 16-weeks from study enrollment. Although the clinical benefit of these drugs in combination has not been established, offering this treatment may provide a therapeutic benefit. The patients will be carefully monitored for tumor response and symptom relief, in addition to safety and tolerability. * To estimate the duration of response to the proposed combined therapy. * To measure the protein of regenerating liver-3 (PRL-3) level of expression in patients at time of relapse. * To measure circulating biomarkers of response (soluble CD30 (sCD30), and thymus and activation-related chemokine (TARC)) in serum samples collected throughout treatment and inhibition of (pSTAT, pAKT) in peripheral blood mononucleated cells (PBMC). Exploratory Objective: * To measure cell-free messenger RNA (cfmRNA) in peripheral blood. * To measure cell-free DNA in peripheral blood

Timeline

Start

2018-12-19

Primary completion

2019-05-23

Completion

2019-05-23

Drugs

Indications