Clinical trial · Interventional
Safety and Efficacy Study of CNOP Chemotherapy in Diffuse Large B Cell Lymphoma
Safety and Efficacy Study of Mitoxantrone Hydrochloride Liposome Injection Plus Cyclophosphamide,Vincristine and Prednison (CNOP)in Diffuse Large B Cell Lymphoma
NCT02595242CI-TRIAL-00027732withdrawnPhase 1ClinicalTrials.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 determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.
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 |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Mitoxantrone 12 mg/m2
- description
- Mitoxantrone Hydrochloride Liposome Injection 12 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5% glucose injection on the first day during a treatment phase of 3 weeks.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Prednisone
- type
- EXPERIMENTAL
- label
- Mitoxantrone 16 mg/m2
- description
- Mitoxantrone Hydrochloride Liposome Injection 16 mg/m2 will be infused intravenously once over 1 hours in 250 ml 5% glucose injection on the first day during a treatment phase of 3 weeks.
- interventionNames
- Drug: Cyclophosphamide
- Drug: Vincristine
- Drug: Prednisone
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent prior to study specific screening procedures; * Favorable index of curative effect of Diffuse Large B Cell Lymphoma confirmed by histological analysis; * ≥ 18 and ≤ 70 years of age, male or female; * Advanced Lymphoma and standard treatments failed; * May benefit from anthracycline-based drugs; * ECOG performance status of 0-2; * More than 4 weeks from the last chemotherapy, more than 4 weeks from the last biotherapy, more than 4 weeks from the last clinical trial drug therapy; * Life expectancy of more than 3 months; * Sexually active women of childbearing potential must use a medically acceptable form of contraception; * Adequate hepatic, renal, cardiac and hematologic functions: leukocyte≥3.5×10\^9/L,neutrophils≥2.0×10\^9/L,platelets≥100×10\^9/L, hemoglobin≥90g/L,creatinine clearance rate≤1.5×ULN, serum bilirubin≤1.5×ULN, ALT≤2.5×ULN(5×for liver metastasis),AST≤2.5×ULN(5×for liver metastasis), alkaline phosphatase≤200 IU/L,Electrocardiogram appeared to be essentially normal, ejection fraction of Heart Doppler ultrasound appeared to be normal. Exclusion Criteria: * Pregnant or lactating women; * Patients with Multiple sclerosis; * Suffering from serious internal disease, including serious heart attack, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,uncontrolled infection, Active peptic ulcer; * Mitoxantrone has been used before; * The cumulative does of doxorubicin and epirubicin before inclusion have surpassed 360 mg/m2 and 600 mg/m2, respectively; * Heart disease was caused after Anthracycline-based drugs used; * Other antineoplastic drugs need to be used in this study; * History of Anthracycline-based drug allergy or liposome drug allergy; * Uncontrolled primary brain tumor or brain metastases;
References
Publications (0)
Data not yet available
No reference posted for this study.