Intensive chemo-immunotherapy as first-line treatment in adult patients with peripheral T-cell Lymphoma PTCL - PTCL intensive chemo-immunotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004234-33-IT

Enrollment

111

Registered

2007-02-19

Start date

2006-10-06

Completion date

Unknown

Last updated

2013-04-08

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

Conditions

Non Hodgkin peripheral T-cell lymphomas MedDRA version: 6.1 Level: PT Classification code 10034623

Interventions

Trade Name: L01XC04 - Alemtuzumab Product Name: Alemtuzumab Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Alemtuzumab Current Sponsor code: PTCL-06 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 and 60 years for Study A patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures and 60 and 75 years for Study B patients older than 75 years are excluded because of the intensive chemo-immunotherapy program Histologically proven diagnosis of PTCL, including the following categories PTCL-U peripheral T-cell lymphoma, unspecified , AILD-T angioimmunoblastic-like T-cell lymphoma , ALKneg ALCL ALK-negative anaplastic large cell lymphoma ,intestinal T - NHL Advanced stage disease stage II-IV or stage I and aaIPI score 2 Written informed consent CD52 expression on neoplastic cells 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: Histological PTCL subset other than PTCL-U, AILD-T, ALKneg-ALCL, intestinal T - NHL Central nervous system localization Positive serologic markers for human immunodeficiency virus HIV , hepatitis B virus HBV , and hepatitis C virus HCV infection Serum bilirubin levels 2 the upper normal limit Clearance of creatinine 50 ml/min DLCO 50 Ejection fraction 45 or myocardial infarction in the last 12 months Pregnancy or lactation Patient not agreeing to take adequate contraceptive measures during the study Psychiatric disease Any active, uncontrolled infection Type I hypersensivity or anaphylactic reactions to proteins drugs Active secondary malignancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy ie complete clinical response at one year of an intensified chemo-immunotherapy program in patients with PTCL;Secondary Objective: Overall survival Disease free-survival Treatment related mortality;Primary end point(s): Efficacy of innovative therapies in non Hodgkin peripheral T-cell lymphomas	—

Countries

Italy

Outcome results

None listed

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