Oral Panobinostat Adult Patients DLBCL Relapsed/Refractory Stem Cell Transfusion (ASCT) or Not Eligible for ASCT
Status:
Completed
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
Treatment of adult patients with Diffuse Large B-cell Lymphoma (DLBCL), relapsed or
refractory to previous CHOP-R (or CHOP-R like regimen) front line therapy, relapsed or
refractory to second or subsequent salvage therapies which included high dose therapy with
autologous stem cell support (ASCT).
Treatment of adult patients with DLBCL relapsed or refractory to front line therapy with
CHOP-R (or CHOP-R like regimen) or subsequent treatments, who are not consider eligible for
ASCT consolidation because of age, co-morbidities, impossibility to perform ASCT.
The trial is conducted according to the optimal two-stage design of Simon with alpha 0.05 and
beta 0.10, considering the following two hypotheses: first a response rate (RR) less than 10%
is of no further interest; and second, an RR 30% is clinically meaningful. In the initial
stage, 18 patients have to enter onto the study. If less than 3 responses (Phase:
Phase 2