Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP (A-CHOP-14)

University of Göttingen

Status and phase: Unknown; Phase 3

Conditions: Extranodal NK/T-cell Lymphoma; Peripheral T Cell Lymphoma, Unspecified; Angioimmunoblastic Lymphadenopathy

Treatments: Biological: alemtuzumab; Drug: chemotherapy

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00725231

DSHNHL 2006-1B / ACT-2

BMBF GFVT 01014715

Details and patient eligibility

About

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.

Enrollment: 274 estimated patients

Sex: All

Ages: 61 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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274 participants in 2 patient groups

Arm A

Active Comparator group

Description:

Chemotherapy with dose dense CHOP-14, 6 cycles

Treatment:

Drug: chemotherapy

Arm B

Experimental group

Description:

Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles

Treatment:

Drug: chemotherapy

Biological: alemtuzumab