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
- Conditions
- T cell lymphoma10025321
- Registration Number
- NL-OMON31642
- Lead Sponsor
- ordic Lymphoma Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Event-free survival at 3 yr</p><br>
- Secondary Outcome Measures
Name Time Method <p>overall survival at 3 yr<br /><br>progression-free survival at 3 yr<br /><br>responses (%CR and %PR), at the end of therapy<br /><br>time to progression<br /><br>relation CD52 expression and response-rate<br /><br>safety addition of alemtuzumab to CHOP measured by incidences of infections</p><br>