PTCL Clinical Trial
Official title:
A Phase I Trial of Volasertib Plus Romidepsin in Patients With Relapsed/Refractory Peripheral T Cell and Cutaneous T Cell Lymphoma
This is a phase I study of the combination of volasertib and romidepsin in patients with relapsed/refractory peripheral T cell lymphoma (PTCL) or stage IIB-IV cutaneous T cell lymphoma (CTCL). This study will determine the maximum tolerated dose (MTD) of this combination by treating cohorts of patients at a certain dose combination. The investigators will use a Bayesian design to determine the dose combination for the next cohort of patients and to determine the MTD. Overall response rate as well as adverse events will be monitored and reported.
This is a non-randomized, unblinded single arm Phase I multi-center trial to determine the
maximum tolerated dose (MTD) of the combination of volasertib and romidepsin in patients
with relapsed/refractory peripheral T cell (PTCL) and cutaneous T cell (CTCL) lymphoma.
Primary Objectives:
1. Determine the maximum tolerated dose (MTD) of the combination of romidepsin and
volasertib in patients with relapsed/refractory peripheral T cell and cutaneous T cell
lymphoma.
Secondary Objectives:
1. Evaluate the overall response rate (ORR) to the combination of romidepsin and
volasertib in patients with relapsed/refractory peripheral T cell and cutaneous t cell
lymphoma.
2. Define gene expression signatures and patterns of acquired tumor mutations that
dynamically correlate to clinical response to romidepsin/volasertib combination therapy
in cutaneous T cell lymphoma (CTCL) through longitudinal RNA sequencing of tumor
samples.
Dose Combinations
(-1): Volasertib 50mg/m2 Days 1 & 8; Romidepsin 10mg/m2 Days 1, 8 & 15
(1-starting dose): Volasertib 75mg/m2 Days 1 & 8; Romidepsin 12mg/m2 Days 1, 8 & 15 (2):
Volasertib 100mg/m2 Days 1 & 8; Romidepsin 12mg/m2 Days 1, 8 and 15 (3): Volasertib 100mg/m2
Days 1 & 8; Romidepsin 14mg/m2 Days 1, 8 and 15 (4): Volasertib 150mg/m2 Days 1 & 8;
Romidepsin 14mg/m2 Days 1, 8 and 15
Each cycle is 28 days Each drug is given intravenously
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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