An Open-Label Phase 2 Trial of Nanatinostat Plus Valganciclovir in Patients With EBV+ Relapsed/Refractory Lymphomas

Duration of Response (DOR)

Interval of time from date of first observed complete or partial response per 2007 International Working Group (IWG) criteria to the date of documented disease progression or death due to any cause, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. DOR was censored at the time of study withdrawal for hematopoietic stem cell transplant, or at the time of study termination, whichever was earlier, for patients whose disease was still in response.

Time frame: Up to approximately 2 years

Time to Next Anti-Lymphoma Treatment (TTNLT)

Interval of time from the start of study drug treatment to the date of next anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy, or immunotherapy).

Time frame: Up to approximately 3 years

Time to Progression (TTP)

Interval of time from the start of study drug treatment to the date of disease progression, where disease progression is defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir. TTP was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression.

Time frame: Up to approximately 3 years

Progression-Free Survival (PFS)

Interval of time from the start of study drug treatment to the date of first documented disease progression (defined by 2007 IWG criteria as any new lesion or increase by ≥ 50% of previously involved sites from nadir), initiation of new antineoplastic therapy, or death from any cause, whichever occurred first. PFS was censored at the time of study withdrawal for hematopoietic stem cell transplant, at the time of study treatment withdrawal (or at the time of crossover from monotherapy to combination therapy), or at the time of study termination, whichever was earliest, for patients without reported disease progression or death.

Time frame: Up to approximately 3 years

Overall Survival (OS)

Interval of time from the start of study drug treatment to the date of death for any reason. OS was censored at the time of study withdrawal or study termination, whichever was earlier, for patients without reported death.

Time frame: Up to approximately 3 years

Number (Percentage) of Participants With Adverse Events (AEs)

Number (percentage) of patients experiencing at least one treatment-emergent adverse event, defined as those untoward medical events with onset after the first dose of study drug or existing events that worsened after the first dose during the study

Time frame: Up to approximately 2 years

Pharmacokinetic (PK) Parameter - Time to Maximum Plasma Concentration [Tmax]

Defined as the time required to reach peak plasma concentration \[Cmax\] after study drug administration

Time frame: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

Pharmacokinetic (PK) Parameter - Maximum Plasma Concentration [Cmax]

Defined as the peak plasma concentration \[Cmax\] after study drug administration

Time frame: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

Pharmacokinetic Parameter - Area Under the Plasma Concentration-Time Curve [AUC0-t]

Defined as the area under the concentration-time curve from time 0 to the last measurable plasma concentration

Time frame: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)

Pharmacokinetic (PK) Parameter - Half-Life [t1/2]

Defined as the time required to reduce plasma concentration by 50% after study drug administration

Time frame: Cycle 1 Day 1 and Cycle 6 Day 1 at pre-dose and 1, 2, 4, and 6 hours post-dose (each cycle was 28 days)