Studies of romidepsin as a single agent for treating mature T-cell lymphomas.
Studies | Setting | Study design | N | PTCL subtypes | Median N of prior therapies | ORR | CR rate | PFS | Median duration of response |
---|---|---|---|---|---|---|---|---|---|
Coiffeir |
RR | Phase 2, multicenter | 130 | PTCL NOS (N=69, 53%) | 2 (1–8) | 25% | 15% | 4 mo | 28 (1–48+) mo |
PTCL | AITL (N=27, 21%) | ||||||||
Piekarz |
RR | Phase 2, multicenter | 47 | PTCL NOS (N=27, 59%) | 3 (1–11) | 38% | 18% | 8.9 mo | 8.9 (2–74) mo |
PTCL | AITL (N=7, 15%) | ||||||||
Maruyama |
RR | Phase 1/2 multicenter | 50 | PTCL NOS (N=20, 42%) | 7.1 (1.2–82.9) | 44% | 23% | 5.6 mo | 11.1 mo |
PTCL | AITL (N=21, 44%) | ||||||||
CTCL |
Abbreviations: AITL, angioimmunoblastic T-cell lymphoma; CR, complete response; ORR, overall response rate; PFS, progression-free survival; PTCL NOS, peripheral T-cell lymphoma not otherwise specified; RR PTCL, relapsed and refractory PTCL.