Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP

Phase 3

• Conditions: Peripheral T Cell Lymphoma, Unspecified; Angioimmunoblastic Lymphadenopathy; Extranodal NK/T-cell Lymphoma
• Interventions: Drug: chemotherapy; Biological: alemtuzumab

• Registration Number: NCT00725231
• Lead Sponsor: University of Göttingen

Brief Summary

Peripheral T cell lymphomas comprise 10-15% of all malignant lymphomas. The prognosis is significantly worse than that of aggressive B cell lymphomas. The prospects of elderly patients are especially poor, with an estimated disease free survival of only 25% after three years. Previous phase II trials have demonstrated a significant activity of the monoclonal anti CD52 antibody alemtuzumab in primary and relapsed T cell lymphoma. The investigators thus propose to investigate the value of adjuvant alemtuzumab in combination with dose dense CHOP-14 in patients with previously untreated peripheral T cell lymphoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-30
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• all risk groups of peripheral T cell lymphoma
• performance status ECOG 0-2
• written consent
• measurable disease

Exclusion Criteria

• stage I N without bulky disease
• already initiated treatment
• serious accompanying disorder or impaired organ function
• bone marrow involvement >25%
• HIV positivity
• leukemic manifestation of lymphoma
• simultaneous participation in another trial
• platelets < 100 000/ mm, leukocytes < 2500 /mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	chemotherapy	Chemotherapy with dose dense CHOP-14, 6 cycles
Arm B	alemtuzumab	Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
Arm B	chemotherapy	Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles

Primary Outcome Measures

Name	Time	Method
Event free survival	3 years

Secondary Outcome Measures

Name	Time	Method
immune reconstitution after alemtuzumab CHOP	3 years
Rate of complete and partial remissions	4 months after inclusion
treatment related deaths	time of occurence
Overall survival	@ 3 years
protocol adherence	4 months of treatment

Trial Locations

Locations (1)

University of Göttingen; 🇩🇪 Göttingen, Lower Saxony, Germany