A randomized phase III study to evaluate the efficacy of chemoimmunotherapy with the monoclonal antibody Campath-1H (Alemtuzumab) given in combination with 2-weekly CHOP versus 2-weekly CHOP alone in elderly patients with previously untreated systemic peripheral T-cell lymphomas - HOVON 91 T-NHL / ACT-2 trial

niversity Medicine Goettingen0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•1. Age: 61 - 80 years
•2. All risk groups, including stage I with bulk (>= 7.5 cm) and stages II to IV, except stage I with no further IPI risk factor (LDH, ECOG, stage, E>1) beside the age over 60
•3. Confirmed histological diagnosis of peripheral T cell NHL of the following types:
•peripheral T-cell lymphoma PTCL-NOS
•Angioimmunoblastic T cell lymphoma
•intestinal T/NK-cell lymphoma (± enteropathy)
•hepatosplenic lymphoma
•subcutaneous panniculitis-like PTCL (gamma-delta T-cell lymphoma)
•4. Performance status: ECOG 0 - 2 (Karnofsky index: 60 - 100%). ECOG 3 is acceptable, if lymphoma related.
•5. Measurable disease
•6. written consent of the patient

•1. Stage I with IPI 0 and without bulk
•2. Already initiated lymphoma therapy
•3. Serious accompanying disorder or impaired organ function, in particular:
•- severe cardiac dysfunction (NYHA class II-IV; LVEF <45%)
•- severe pulmonary dysfunction (FeV1<50% or DC <50%)
•- 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. Known hypersensitivity to the medications to be used, especially murine or
•chimeric antibodies
•7. primary leukemic lymphoma
•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

发起方

niversity Medicine Goettingen