Trials Sponsors Conditions Drugs Pricing

Conditions

Relapsed or Refractory Peripheral T-cell Lymphomas

Outcome Measures

Primary Outcomes (1)

ORR at the end of 4 courses of S-IDE

Secondary Outcomes (7)

DOR
18-months PFS
18-months OS
TRM
CR by histotypes
+2 more secondary outcomes

Interventions

ETOPOSIDE TEVA 20 mg/ml, concentrato per soluzione per infusione.Type not reported

HOLOXAN 1 g polvere per soluzione per infusioneType not reported

NEXPOVIO 20 mg film-coated tabletsType not reported

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
HOLOXAN 1 g polvere per soluzione per infusione
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
NEXPOVIO 20 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

HOLOXAN 1 g polvere per soluzione per infusione
Named ingredient: Ifosfamide
View registry record
NEXPOVIO 20 mg film-coated tablets
Named ingredient: selinexor
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Histologically confirmed diagnosis of angioimmunoblastic T cell lymphoma (AITL), anaplastic large cell lymphoma ALK negative lymphoma (ALK neg), peripheral T cell lymphoma not otherwise specified (PTCL-NOS), or T helper follicular lymphoma (TFH) according to 2016 WHO classification

Sponsors & Collaborators

Fondazione IRCCS Istituto Nazionale Dei Tumori
Type not reportedlead

Study Sites (8)

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Brescia, 25123, Italy

Alessadro Re+390303998572 alessandro.re@asst-spedalecivili.it

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Bari, Italy

Pellegrino Musto+390805593471 pellegrino.musto@policlinico.ba.it

Universita' Degli Studi Di Torino

Turin, 10126, Italy

Federica Cavallo

Central Study Contacts

S.C di Ematologia

0223902950 paolo.corradini@istitutotumori.mi.it

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

April 9, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-513295-18-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 04:59:53 UTC

Documents

D1_Protocollo 2024-513295-18-00 Redacted

You may not qualify if:

Any significant medical condition, or psychiatric illness that would prevent the subject from participating in the study
Active, unstable cardiovascular function, as indicated by the presence of: o Symptomatic ischemia, or o Uncontrolled clinically significant conduction abnormalities (eg, patients with ventricular tachycardia on anti-arrhythmics are excluded; patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block will not be excluded), or o Congestive heart failure of New York Heart Association Class ≥3 or known left ventricular ejection fraction <40%, or o Myocardial infarction within 6 months prior to C1D1
Female subject who is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to treatment initiation are acceptable
Prior radiation therapy within 30 days prior to starting SIDE
Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. Prior to study entry, any ECHO or MUGA scan abnormality at Screening has to be documented by the investigator as not medically relevant
Subjects with active hepatitis B virus (HBV) or active hepatitis C (HCV)
Known seropositivity for or active viral infection with human immunodeficiency virus (HIV)
Any active gastrointestinal dysfunction interfering with the patient’s ability to swallow tablets, or any active gastrointestinal dysfunction that could interfere with absorption of study treatment
Contraindication to any of the required concomitant drugs or supportive treatments
Patient has received other investigational drugs within 30 days before enrollment
Other severe acute or chronic medical or psychiatric condition, including uncontrolled diabetes, malabsorption, resection of the pancreas or upper small bowel, requirement for pancreatic enzymes, any condition that would modify small bowel absorption of oral medications, or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrollment in this study
Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations