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

University of Göttingen

Status and phase: Completed; Phase 2

Conditions: Peripheral T-Cell Lymphoma

Treatments: Drug: Alemtuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01806337

DSHNHL-2003-1

German High Grade Lymphoma SG (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

41 participants in 1 patient group

Alemtuzumab, antibody

Experimental group

Description:

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

Treatment:

Drug: Alemtuzumab