At a glance
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Phase I/II Study of 5-azacitidine in Combination With Vorinostat in Patients With Relapsed or Refractory DLBCL
In Brief
A Phase 2 clinical trial evaluating azacytidine and vorinostat for Lymphoma. Completed, enrolled 17 participants across 1 site.
Detailed Summary
This will be a phase I/II study of 5-azacitidine in combination with vorinostat in patients with relapsed or refractory DLBCL. Combination therapy with methyltransferase inhibitors and histone deacetylase inhibitors is highly synergistic in DLBCL cells, and both classes of drugs can also synergize powerfully with standard anti-lymphoma chemotheraputics such as doxorubicin in pre-clinical studies. We hypothesize that azacytidine + vorinostat combination therapy will be safe and effective in selected patients with relapsed or refractory DLBCL. We also hypothesize that patients demonstrating objective responses to this combination therapy display specific epigenetic signatures, and that a biomarker or gene classifier can be generated which will identify those patients likely to respond.
Study Details
Timeline
Interventions
* Dose level 1: azacitidine 55 mg/m2 on days 1-5 * Dose level 2: azacitidine 75 mg/m2 on days 1-5 * Dose level 3: azacitidine 55 mg/m2 on days 1-5 * Dose level 4: azacitidine 75 mg/m2 on days 1-5 Each cycle = 28 days. Subjects may receive up to 6 cycles.
* Dose level 1: oral vorinostat at 300 mg BID on Days 1-7. * Dose level 2: oral vorinostat at 200 mg BID on Days 1-7. * Dose level 3: oral vorinostat at 300 mg BID on Days 1-14. * Dose level 4: oral vorinostat at 200 mg BID on Days 1-14. Each cycle = 28 days. Subjects receive up to 6 cycles.