A randomised Phase III trial to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP (Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) versus 2-weekly CHOP alone in elderly patients with previously untreated systemic T- cell Lymphoma Short Title: A-CHOP-14 (elderly) - A-CHOP-14 (elderly)

Phase 1

• Conditions: Primary therapy of patients with Alk-negative T-NHL in patients aged 61 - 80 yearsICD classification codes : ICD-O 9702/3; 9717/3; 9716/3; 9708/3; 9705/3; 9714/3; MedDRA version: 17.1Level: LLTClassification code 10025632Term: Malignant lymphomaSystem Organ Class: 100000004864; MedDRA version: 17.1Level: LLTClassification code 10002464Term: Angiomimmunoblastic (AILD, LgX (Kiel Classification)System Organ Class: 100000004864

• Registration Number: EUCTR2007-000821-23-DE
• Lead Sponsor: niversity Medicine Goettingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-29
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

1. Age:61 - 80 years

2. Risk group:All risk groups, including stage I with bulk (= 7.5 cm) and stages II to IV, exept stage I with no further IPI risk factor (LDH, ECOG, stage, E>1) beside the age over 60

3. Histology:Diagnosis of aggressive non-Hodgkin's lymphoma, confirmed by an excisional biopsy of a lymph node or by a sufficiently extensive biopsy of an extranodal involvement if there is no lymph node involvement. It will be possible to treat all peripheral T-lineage lymphomas with the exception of ALK-positive anaplastic large cell lymphoma and primary cutaneous T-cell lymphomas (Mycosis fungoides, Sezary syndrome and primary cutaneous CD30-positive lymphoproliferations, and transformed primary cutaneous T-cell lymphomas). These lymphomas comprise:

T cell -NHL:
peripheral T-cell lymphoma PTCL-NOS
Lennert's lymphoma
T-zone lymphoma
T-cell lymphoma of the AILD type
anaplastic large cell lymphoma
ALK-
extranodal NK/T-cell lymphoma, nasal type
intestinal T/NK-cell lymphoma (? enteropathy)
hepatosplenic gamma-delta lymphoma
subcutaneous panniculitis-like PTCL

4. Performance status:Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100%). The general status of each patient is to be assessed at time of randomisation and can thus take place after initiation of prephase treatment. A performance status of ECOG 3 will allow inclusion, if it is lymphoma related. The pretreatment status is to be documented in the staging CRF; the performance after the prephase treatment is also to be documented in the relevant CRF for the prephase treatment (see Appendix). A definition of the performance status is provided in the Appendix.

5. Declaration of center participation

6. written consent of the patient

7. measurable disease

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

1.Stage I with IPI 0 and without bulk
2.Already initiated lymphoma therapy (except for the prephase treatment specified for this study)
3.Serious accompanying disorder or impaired organ function, in particular:
-Cardiac: angina pectoris CCS >2, cardiac failure NYHA >2 and/or EF <45% or FS<25% in echocardiography/nuclear medicine examination
- Pulmonary: abnormal blood gases; in this case, the patient is to be excluded if the resultant pulmonary function test shows FeV1<50% or a diffusion capacity <50% of the reference values
-Renal: creatinine >2 times the upper reference limit, unless related to NHL
-Hepatic: bilirubin >2 times the upper reference limit, unless related to NHL
-Uncontrollable diabetes mellitus (prephase treatment with prednisone!)
4.Platelets <100 000/mm3, leukocytes <2500/mm3
5.Bone marrow involvement >25%
6.Primary leukemic manifestation of the lymphoma
7.Known hypersensitivity to the medications to be used, especially murine or chimeric antibodies
8.Known HIV-positivity
9.Active hepatitis infection, active CMV infection, active systemic fungal infection, active infection with mycobacterium tuberculosis or atypical tuberculosis
10.Suspicion that patient compliance will be poor
11.Simultaneous participation in any other study protocol
12.Prior chemo- or radiotherapy for malignancy
13.Other concomitant malignant disease (history of active cancer during the past 5 years, except basal carcinoma of the skin or stage 0 cervical carcinoma)
14.Non-conformity to eligibility criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified