Clinical trial · Interventional
RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
A Phase I/II Study of RAD001 Combined With CHOP in Newly Diagnosed Peripheral T-cell Lymphomas
- 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)
The urgent need for new effective therapy for T-cell lymphoma patients and promising results observed so far in trials with RAD001(everolimus, mTOR inhibitor) strongly warrants the investigation of RAD001 combined with CHOP as a first-line treatment in peripheral T-cell lymphoma patients. Thus, we designed a phase I/II study with the combination of RAD001 with CHOP chemotherapy for newly diagnosed peripheral T-cell lymphoma patients. Phase I 1. Primary objective : To define the maximum tolerable dose 2. Secondary objective * To evaluate the dose-limiting toxicity * To evaluate the pharmacokinetics of RAD001 * Pharmacogenomic profiling Phase II 1. Primary objective : To evaluate the overall response rate 2. Secondary objective * To estimate the time to progression * To estimate overall survival * Pharmacogenomic profiling
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large Cell Lymphoma, ALK-negative | Anaplastic Large Cell Lymphoma, ALK-Negative | ONTOLOGY_EXACT | 0.98 |
| Angioimmunoblastic T Cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Cutaneous T Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Peripheral T Cell Lymphoma Unspecified | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 (Everolimus) | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001-CHOP
- description
- Prospective multicenter open-label phase I/II study Phase I: RAD001 2.5 - 10 mg PO daily D1-14 + CHOP every 3 weeks Phase II: Determined dosage of RAD001 + CHOP every 3 weeks Treatment will be continued until planned 6 cycles or disease progression
- interventionNames
- Drug: RAD001 (Everolimus)
Primary outcomes (1)
- measure
- determination of the maximum tolerable dose and evaluation of response rate
- timeFrame
- Phase I for maximal tolerable dose and phase II for efficacy
Secondary outcomes (1)
- measure
- doe-limiting toxicity and pharmacogenomics
- timeFrame
- Phase I/II
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically proven peripheral T-cell lymphoma, unspecified, (PTCL), ALK-negative anaplastic large cell T-cell lymphoma (ALCL), Angioimmunoblastic T cell lymphoma (AITL), Cutaneous T-cell lymphoma 2. Adequate organ function as defined by the following criteria: A.Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase (SGOT)) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase (SGPT)) ≤2.5 x local laboratory upper limit of normal (ULN), or AST and ALT less than or equal to 5 x ULN if liver function abnormalities are due to underlying malignancy B.Total serum bilirubin ≤1.5 x ULN C.Absolute neutrophil count (ANC) ≥1500/µL D.Platelets ≥100,000/µL E.Hemoglobin ≥9.0 g/dL (may be transfused or erythropoietin treated) F.Serum calcium ≤12.0 mg/dL G.Serum creatinine ≤1.5 x ULN 3. At least one measurable lesion 4. ECOG PS 0-2 5. Informed consent 6. Age 20 to 70 years old Exclusion Criteria: 1. Prior radiation therapy or surgery within 4 weeks prior to study entry 2. History of central nervous system (CNS) metastases 3. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2. 4. Pregnancy or breastfeeding. 5. Hepatitis B virus surface antigen positive 6. Extranodal NK/T cell lymphoma 7. Mycosis fungoides 8. ALK-positive Anaplastic large cell lymphoma
References
Publications (1)
- DERIVEDBanchi M, Cox MC, Bandini A, Orlandi P, Tacchi C, Stefanelli F, Chericoni S, Bocci G. Linifanib alone and in combination with metronomic chemotherapy is active on cutaneous T-cell lymphoma cells by targeting the AKT/mTOR signaling pathway. Invest New Drugs. 2025 Feb;43(1):135-146. doi: 10.1007/s10637-024-01501-8. Epub 2025 Jan 17. PMID 39821757