CHO(E)P-14 Followed by Alemtuzumab Consolidation in Peripheral T Cell Lymphoma

NCT ID: NCT01806337

Last Updated: 2013-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2011-02-28

Brief Summary

Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation

Detailed Description

Peripheral T cell lymphoma patients of all subtypes according to WHO are treated with an induction of 6 cycles of CHOP-etoposide-14 (if below 60 years of age) oder CHOP-14. If at least a PR is reached, consolidation with alemtuzumab, total dose 133 mg, is given i.v.

Conditions

Peripheral T-Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alemtuzumab, antibody

alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg

Group Type: EXPERIMENTAL

Alemtuzumab

Intervention Type: DRUG

Consolidation after CHOP induction

Interventions

Alemtuzumab

Consolidation after CHOP induction

Intervention Type: DRUG

Other Intervention Names

MabCampath

Eligibility Criteria

Inclusion Criteria

• all risk groups in international prognostic index
• diagnosis of aggressive T-cell-lymphoma, confirmed by an excisional biopsy of a lymph node or by sufficiently extensive biopsy of an extranodal involvment, if there is no lymph node involvment.
• these lymphomas comprise: peripheral T-cell lymphoma PTCL-NOS Lennert´s lymphoma T-zone lymphoma angioimmunoblastic T-cell-lymphoma
• Performance status: ECOG (Eastern Cooperative Oncology Group Score) 0-3(Karnofsky index 40-100%)
• written consent of the patient
• Declaration of center participation

Exclusion Criteria

• Already initiated lymphoma therapy(exept for the prephase treatment specified for this study)
• Serious accompanying disorder or impaired organ function
• bone marrow involvement>25%
• Known hypersensitivity to medications to be used
• Know HIV-positivity
• Active hepatitis infection, active CMV infection, prior florid tuberculosis
• floride systemic infections
• suspicion that patient compliance will be poor
• Simultaneous participation in any the study protocol
• prior chemo-or radiotherapy for malignancy
• other concomitant malignant disease
• Pregnancy or lactation period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Göttingen

OTHER

Sponsor Role: lead

Responsible Party

Lorenz, Trümper, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lorenz Truemper

Role: PRINCIPAL_INVESTIGATOR

German High Grade Non Hodgkin´s Lymphoma Study Group

Other Identifiers

German High Grade Lymphoma SG

Identifier Type: OTHER

Identifier Source: secondary_id

DSHNHL-2003-1

Identifier Type: -

Identifier Source: org_study_id