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

Phase III Study of CHOP-14 Plus or Minus Alemtuzumab in Peripheral T-cell Lymphoma of the Elderly

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00725231

Acronym

A-CHOP-14

Enrollment

274

Registered

2008-07-30

Start date

2008-02-29

Completion date

2014-03-31

Last updated

2012-05-07

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

Conditions

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

Keywords

T cell lymphoma

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.

Interventions

BIOLOGICALalemtuzumab

Addition of 30 mg Alemtuzumab by subcutaneous application for the first 4 cycles

DRUGchemotherapy

dose dense chemotherapy with CHOP-14, 6 cycles, + G-CSF

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

61 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Event free survival	3 years

Secondary

Measure	Time frame
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
immune reconstitution after alemtuzumab CHOP	3 years

Countries

Germany

Contacts

Primary ContactLorenz H Trümper, MD

lorenz.truemper@med.uni-goettingen.de+49 551 398535

Backup ContactGerald G Wulf, MD

gwulf@med.uni-goettingen.de+49 551 396303

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026