Pentamidine + Salvage Chemo for Relapsed/Refractory Classical Hodgkin Lymphoma
Status:
Completed
Trial end date:
2019-05-23
Target enrollment:
Participant gender:
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