Clinical trial · Interventional
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
- 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)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Angioimmunoblastic Lymphadenopathy | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Extranodal NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
| Peripheral T Cell Lymphoma, Unspecified | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Chemotherapy with dose dense CHOP-14, 6 cycles
- interventionNames
- Drug: chemotherapy
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Chemotherapy with dose dense CHOP-14, 6-cycles, together with 30mg Alemtuzumab s.c. for the first 4 cycles
- interventionNames
- Biological: alemtuzumab
- Drug: chemotherapy
Primary outcomes (1)
- measure
- Event free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 61 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available