Phase I, open-label, 3+3 dose-escalation trial evaluating duvelisib (PI3K-δ/γ inhibitor) combined with oral azacitidine (BMS-986345) in 14 patients with relapsed/refractory T-cell lymphoma to identify the maximum tolerated dose (MTD).
ORR was 46% (6/14), with 31% CR (4/14) and 15% PR (2/14); all 4 evaluable TFH-phenotype patients achieved CR. Median PFS was 2.2 months, median OS 10.2 months, and median duration of response was not reached (3 responders bridged to allogeneic transplant).
Very small sample (N=14) limits generalizability; single-arm design with no comparator; TFH subtype finding is hypothesis-generating only given the small denominator.
Duvelisib plus oral azacitidine shows a manageable toxicity profile and meaningful activity—especially deep responses in TFH-phenotype TCL that enabled bridge to transplant. Clinicians should consider TFH subtype selection in future trials; randomized evaluation in this subgroup is warranted.
