RADIOCHEMIOTERAPIA CON TEMOZOLOMIDE CONCOMITANTE E ADIUVANTE NEL TRATTAMENTO DEI LINFOMI CEREBRALI PRIMITIVI DOPO METOTREXATE AD ALTE DOSI: STUDIO DI DOSE ESCALATION - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003254-28-IT

Enrollment

Registered

2008-04-09

Start date

2008-03-15

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

primary central nervous lymphoma MedDRA version: 9.1 Level: HLGT Classification code 10025323 Term: Lymphomas NEC

Interventions

Trade Name: TEMODAL Pharmaceutical Form: Capsule, hard INN or Proposed INN: Temozolomide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: histologic diagnosis of PCNSL ND-MTX Exclusive localization of intracranial disease written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: hiv pregnancy organ failure

Design outcomes

Primary

Measure	Time frame
Main Objective: evaluation of maximum tolerated dose of temozolomide concomitant to radiation therapy in patients treated with HD-MTX;Secondary Objective: evaluation of response rate and survival;Primary end point(s): concomitant temozolamide mtd	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026