Clinical trial · Interventional
Phase I Study of Mitoxantrone Hydrochloride Liposome Injection
Phase I Dose Escalation Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Malignant Lymphoma
NCT02131688CI-TRIAL-00014431unknownPhase 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 the maximum tolerated dose,the safety and effectiveness of Mitoxantrone Hydrochloride Liposome Injection.
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 |
|---|---|---|---|
| Malignant Lymphoma | Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mitoxantrone Hydrochloride Liposome | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mitoxantrone Hydrochloride Liposome
- interventionNames
- Drug: Mitoxantrone Hydrochloride Liposome
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Mitoxantrone Hydrochloride Liposome Injection
- timeFrame
- 4 months
Secondary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must compliance with the requirements and restrictions listed in the consent form * Patients with Pathology and / or cytologically proven malignant lymphoma * Patients must be 18-70 years old ,both male and female * Failure of standard chemotherapy * Patients have no better choice and may be benefit from the use of anthracyclines * Patients with Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2 * Objective tumor from the last chemotherapy, biological therapy or other experimental interval treatment least 4 weeks * Expected survival time ≥ 3 months * Patients agreed to take effective contraceptive measures during the trial * Blood routine, liver and kidney function, cardiac function examination in accordance with the following requirements. Exclusion Criteria: * Pregnancy and breast-feeding women * Multiple sclerosis * Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease * Patients with heart disease induced by anthracycline * Patients requiring other antineoplastic treatment * Patients with temperature above 38 degrees or active infection that may effects in clinical tests * Patients are allergic to anthracycline and liposomal drugs * Patients are allergic to eggs,egg products,soybean and soybean products * Patients with uncontrolled primary or metastatic brain tumorsMultiple sclerosis * Patients that have histories of ischemic heart disease and heart congestive,arrhythmia that need to be a treatment and significant valvular disease * Patients with heart disease induced by anthracycline * Patients requiring other antineoplastic treatment * Patients with temperature above 38 degrees or active infection that may effects in clinical tests * Patients are allergic to anthracycline and liposomal drugs * Patients are allergic to eggs,egg products,soybean and soybean products * Patients with uncontrolled primary or metastatic brain tumors * Total amount of Doxorubicin(or Pirarubicin)≥360mg/m2,Epirubicin ≥600mg/m2
References
Publications (0)
Data not yet available
No reference posted for this study.