Clinical trial · Interventional
Alemtuzumab and Combination Chemotherapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Peripheral T-Cell Lymphoma
CHOP-Campath, A Pilot Study of CHOP Plus Campath for the Primary Treatment of ALK-ve Peripheral T Cell Lymphoma [CHOP-CAMPATH]
- 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)
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from growing. Giving alemtuzumab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of alemtuzumab when given together with combination chemotherapy and to see how well it works in treating patients with stage I , stage II , stage III, or stage IV peripheral T-cell lymphoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Biological | Alemtuzumab | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| flow cytometry | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| prednisolone | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Immediate toxicity (incidence of infusion-related reactions)
- measure
- Hematopoietic toxicity (number of cycles of therapy associated with neutrophils < 0.5e9/L or platelets < 50e9/L)
- measure
- Incidence of infection (number of days with fever ≥ 38 degrees C, days of intravenous antibiotics, number of inpatient days, number of episodes of cytomegalovirus reactivation)
Secondary outcomes (6)
- measure
- Disease response (remission rate [complete response and partial response])
- measure
- Disease outcome (time to progression and overall survival at 2 years from completion of therapy)
- measure
- Immune reconstitution (time to recover peripheral blood CD4 count to 0.2 e9/L)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of peripheral T-cell lymphoma (PTCL), including the following subtypes: * PTCL not otherwise specified * Angioimmunoblastic T-cell lymphoma * Anaplastic lymphoma kinase-negative anaplastic large cell lymphoma * Intestinal T-cell lymphoma * Bulky stage IA and stages IB-IV disease (Ann Arbor staging system) * Expression of CD52 by the tumor * Measurable or evaluable disease * No anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma * No CNS involvement with non-Hodgkin lymphoma PATIENT CHARACTERISTICS: * WHO performance status 0-2 * No presence of other serious, uncontrolled medical conditions * No significant anthracycline-related cardiac impairment * LVEF ≥ 50% * Creatinine ≤ 1.5 mg/dL * Bilirubin ≤ 2 times normal value unless due to disease * Not pregnant or nursing * Fertile patients must use effective barrier contraception during and for 1 month after completion of study treatment * No previous malignancy except adequately treated nonmelanoma skin cancer or cervical intraepithelial neoplasia * No positive serology or non-consenting to test for any of the following: * HIV * Hepatitis B or C * Human T-lymphotropic virus type 1 (HTLV-1) PRIOR CONCURRENT THERAPY: * No prior cytotoxic chemotherapy * Prior radiotherapy may be allowed at the trial coordinator's discretion * Concurrent consolidation radiotherapy may be given at the clinician's discretion
References
Publications (1)
- DERIVEDPhillips EH, Devereux S, Radford J, Mir N, Adedayo T, Clifton-Hadley L, Johnson R. Toxicity and efficacy of alemtuzumab combined with CHOP for aggressive T-cell lymphoma: a phase 1 dose-escalation trial. Leuk Lymphoma. 2019 Sep;60(9):2291-2294. doi: 10.1080/10428194.2019.1576870. Epub 2019 Feb 18. No abstract available. PMID 30773077