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 and consolidated by autologous stem cell transplant, in young patients with previously untreated systemic peripheral T-cell lymphomas - Alemtuzumab and CHOP in T-cell Lymphoma in young patients, The ACT-1 Trial

ordic Lymphoma Group0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•1. Age: 18-65 years
•2. All stages, including stage I with bulk (>= 7.5 cm)
•3. Confirmed histological diagnosis of peripheral T cell NHL of the following types:
•peripheral T-cell lymphoma PTCL-NOS
•Angioimmunoblastic T cell lymphoma
•Anaplastic large cell lymphoma, only if primary systemic and ALK-negative
•intestinal T/NK-cell lymphoma (± enteropathy)
•hepatosplenic gamma-delta lymphoma
•subcutaneous panniculitis-like PTCL
•extranodal NK/T cell lymphoma, nasal type
•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
•7. life expectancy of 3 months or longer

•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 >150 umol/l, unless related to NHL
•- Hepatic: bilirubin >2.5 times the upper reference limit, unless related to NHL
•- Uncontrollable diabetes mellitus (prephase treatment with prednisone!)
•4. T-cell malignanies of other categories
•5. CNS involvement
•6. Known hypersensitivity to the medications to be used, especially murine or
•chimeric antibodies
•7. uncontrolled asthma or allergy
•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

ordic Lymphoma Group