Clinical trial · Interventional
Thalidomide Combined With R-CHOP in Newly Diagnosed,Untreated Double-expressor Diffuse Large B-Cell Lymphoma Patients
An Randomized, Open-label, Phase III Study Comparing Thalidomide Combined With R-CHOP and R-CHOP in Newly Diagnosed Double-expressor Diffuse Large B-Cell Lymphoma Patients
NCT03318835CI-TRIAL-00030022unknownPhase 3ClinicalTrials.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)
The purpose of this study is to evaluate the efficacy of Thalidomide combined with R-CHOP(RT-CHOP) in newly diagnosed,untreated double-expressor Diffuse Large B-Cell Lymphoma patients (DLBCL)
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 |
|---|---|---|---|
| Thalidomide | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| R-CHOP | Drug | — | UNRESOLVED |
| Thalidomide combined with R-CHOP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Thalidomide combined with R-CHOP
- description
- rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 \[capped at 2.0 mg\], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6 Thalidomide 200mg PO QN D1-21
- interventionNames
- Drug: Thalidomide combined with R-CHOP
- type
- ACTIVE_COMPARATOR
- label
- R-CHOP
- description
- rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 \[capped at 2.0 mg\], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6
- interventionNames
- Drug: R-CHOP
Primary outcomes (1)
- measure
- 3 year PFS
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age range ≥18 years old 2. Eastern Cooperative Oncology Group performance status 0 to 2; 3. Newly diagnosed, untreated, histological confirmed diffuse large B cell lymphoma, non-GCB subtype, and Myc≥40% as well as Bcl-2≥70% through immunohistochemistry; 4. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT. 5. Patients have written informed consent to participate in the study. 6. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed on signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention. 7. White blood cell ≥ 3.5×109/L, absolute neutrophil count ≥ 1.5×109/L,platelet ≥ 80×109/L,hemoglobin ≥ 90 g/L 8. total bilirubin \< 1.5×upper limit of normal(ULN), ALT and AST \< 1.5× ULN 9. serum creatine \<1.5×ULN, and creatinine clearance rate (CCR) ≥ 30 ml/min Exclusion Criteria: 1. Presence of CNS involvement 2. Particular kind of DLBCL,such as primary mediastinal/thymic B-cell lymphoma, elderly EBV positive DLBCL, primary cutaneous large B lymphoma. 3. History of myocardial diseases, such as congenital heart disease, pericardial disease, heart failure, myocardial infarction, coronary heart disease, valvular heart disease, myocardosis, arrhythmia. 4. History of severe chronic cutaneous diseases. 5. History of allergic asthma or severe allergic diseases. 6. Uncontrolled hypertension and diabetes. 7. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix 8. HIV, HCV, or syphilis infection; 9. Presence of active HBV infection(HBV-DNA≥104); 10. Pregnant or lactating women 11. Previously received organ transplant 12. Having usage of Thalidomide; 13. History of deep vein thrombosis 14. Serious uncontrolled infection 15. Having contraindications to the use of large doses of hormone, such as uncontrolled hyperglycemia, gastric ulcer, mental disorder. 16. Severe neurol of mental illness, including dementia and epilepsy.
References
Publications (0)
Data not yet available
No reference posted for this study.