Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT05011058
Brief Summary:
A Phase 2 study to evaluate the efficacy of nanatinostat in combination with valganciclovir in patients with relapsed/refractory EBV-positive lymphomas
Detailed Description:
Patients with EBV-associated lymphomas have inferior outcomes with standard-of-care therapies compared to those with EBV-negative disease. Nanatinostat is a selective class I HDAC inhibitor which induces EBV lytic phase protein generation, activating (val)ganciclovir to its cytotoxic form. This open-label, multicenter, multinational, single-arm, Phase 2 basket study employs a Simon's 2-stage design to allow termination of enrollment into cohorts where treatment appears futile, and will include the following cohorts of patients with EBV+ relapsed/refractory lymphomas:
1. Diffuse large B-cell lymphoma (DLBCL)
2. Extranodal natural killer/T-cell lymphoma (ENKTL)
3. Peripheral T-cell lymphoma (PTCL), including angioimmunoblastic T-cell lymphoma (AITL) and PTCL not otherwise specified (PTCL-NOS)
4. Hodgkin lymphoma (HL)
5. Post-transplant lymphoproliferative disorders (PTLD)
6. Human immunodeficiency virus (HIV)-associated lymphomas (HIV-L)
7. EBV+ lymphomas other than the above
The study was terminated prematurely and did not reach its target enrollment.
Study:
NCT05011058
Study Brief:
Protocol Section:
NCT05011058