MAINTENANCE TREATMENT WITH ALEMTUZUMAB Campath AS AN ALTERNATIVE TO ALLOGENIC TRANSPLANTATION IN PATIENTS WITHOUT COMPATIBLE DONOR IN PATIENTS WITH PERIPHERAL T CELL LYMPHOMA - ND

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001164-24-IT

Enrollment

Registered

2006-08-03

Start date

2006-11-14

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

patients with Perpheral T cell Lymphoma MedDRA version: 6.1 Level: HLGT Classification code 10025321

Interventions

Trade Name: MABCAMPATH*IV 3F 3ML 10MG/ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Alemtuzumab Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed diagnosis of Peripheral T cell Lymphoma Entheropathy-type T-cell Lymphoma; Hepatosplenic T-cell Lymphoma; Subcutaneous Panniculitis-like T-cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Peripheral T-cell Lymphoma, unspecified - Stage I IV - Performance Status ECOG 0 3 - Age 18 65 years - CD52 positivity - Previous induction therapy with CHOP or DHAP, followed by autologous bone marrow transplantion - Complete or partial 75 response at the time of inclusion into the study - HIV, HbsAg, HCV negativity - CMV Ag and/or Ab anti CMV IgM negativity - ANC 1.500 x 109/L and PLT 75 x 109/L - Normal renal and hepatic functions - LVEF 50 - Documented absence of infections - No previous or concomitant neoplasms - No CNS involvement - Use of effective contraception - Negative pregnancy test - 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Cardiopathy- LVEF 40 - No previous treatment - Myelodysplasic syndromes - HbsAg, HIV and HCV-RNA positivity

Design outcomes

Primary

Measure	Time frame
Main Objective: to assess the efficacy of Campath as maintenance therapy in T cell lymphomas, after induction therapy with chemotherapy followed by autologous bone marrow transplantation, in terms of progression free survival;Secondary Objective: to assess overall survival, response duration and toxicity;Primary end point(s): progression free survival	—

Countries

Italy

Outcome results

None listed

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