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Pilot phase II study of Selinexor in combination with Ifosfamide, Etoposide and Dexamethasone (SIDE) in patients with relapsed or refractory Peripheral T-cell Lymphomas

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513295-18-00
Acronym
PTCL S-IDE
Enrollment
30
Registered
2024-05-20
Start date
2022-08-10
Completion date
Unknown
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Peripheral T-cell Lymphomas

Brief summary

ORR at the end of 4 courses of S-IDE

Detailed description

DOR, 18-months PFS, 18-months OS, TRM, CR by histotypes, Proportion of patients able to undergo SCT, Adverse events (grading/onset/severity) according to SOC and within the CTCAE v.5.0 category

Interventions

DRUGNEXPOVIO 20 mg film-coated tablets
DRUGHOLOXAN 1 g polvere per soluzione per infusione
DRUGDecadron “8 mg/2 ml Soluzione iniettabile”
DRUGETOPOSIDE TEVA 20 mg/ml
DRUGconcentrato per soluzione per infusione.

Sponsors

Fondazione IRCCS Istituto Nazionale Dei Tumori
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
ORR at the end of 4 courses of S-IDE—

Secondary

MeasureTime frame
DOR, 18-months PFS, 18-months OS, TRM, CR by histotypes, Proportion of patients able to undergo SCT, Adverse events (grading/onset/severity) according to SOC and within the CTCAE v.5.0 category—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026