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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31642

Enrollment

Registered

2008-06-06

Start date

2008-05-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

T cell lymphoma

Interventions

the addition of alemtuzumab to standard CHOP-14 followed by autologous transplant

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

Measure	Time frame
Event-free survival at 3 yr	—

Secondary

Measure	Time frame
overall survival at 3 yr progression-free survival at 3 yr responses (%CR and %PR), at the end of therapy time to progression relation CD52 expression and response-rate safety addition of alemtuzumab to CHOP measured by incidences of infections	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)