Clinical trial · Interventional
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
NCT01806337CI-TRIAL-00009667completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective Phase II Study for Treatment Peripheral T-cell Lymphoma, CHOP-14 Plus PEG-Filgrastim Followed by Alemtuzumab Consolidation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alemtuzumab | Drug | Alemtuzumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alemtuzumab, antibody
- description
- alemtuzumab - anti CD 52 antibody administered as consolidation, total dose 133 mg
- interventionNames
- Drug: Alemtuzumab
Primary outcomes (1)
- measure
- Feasibility of alemtuzumab consolidation after CHO(E)P 14 induction chemotherapy
- timeFrame
- average of 24 weeks (treatment duration)
- description
- 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 outcomes (2)
- measure
- rate of complete remissions
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.