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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01806337

Enrollment

Registered

2013-03-07

Start date

2003-07-31

Completion date

2011-02-28

Last updated

2013-03-07

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

Conditions

Peripheral T-Cell Lymphoma

Keywords

peripheral T cell lymphoma, alemtuzumab, consolidation

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.

Interventions

DRUGAlemtuzumab

Consolidation after CHOP induction

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy	average of 24 weeks (treatment duration)	A descriptive approach for the primary endpoint was chosen: Adherence to schedule of alemtuzumab consolidation (number of cycles, dosing, time) - comparison of planned vs given in pts receiving alemtuzumab

Secondary

Measure	Time frame
rate of complete remissions	at week 24 after initiation
Overall survival	5 years

Outcome results

None listed

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