Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies
Status:
Terminated
Trial end date:
2020-01-06
Target enrollment:
Participant gender:
Summary
This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I
followed by a disease focused phase II.
The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and
dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in
patients with lymphoma. The safety and toxicity of this combination will be evaluated
throughout the entire study.
If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is
established, the phase II part of the study will be initiated.
Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and
romidepsin for patients with relapsed or refractory T-cell lymphomas.