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Efficacy and safety of Liposomal Mitoxantrone Hydrochloride in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Multicenter, Non- Interventional and Ambispective Cohort Real-World Study

Efficacy and safety of Liposomal Mitoxantrone Hydrochloride in the Treatment of Relapsed or Refractory Peripheral T-cell Lymphoma: A Multicenter, Non- Interventional and Ambispective Cohort Real-World Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062067
Enrollment
Unknown
Registered
2022-07-21
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral T-cell Lymphoma

Interventions

case series:none

Sponsors

Harbin Institute of Hematology and Oncology/ Beijing Cancer Hospital/ Cancer Prevention and Treatment Center of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age =18; 2. Histologically confirmed diagnosis of Peripheral T-cell lymphoma; (1) Peripheral T-cell lymphoma unspecified (PTCL-NOS); (2) Angioimmunoblastic T-cell lymphoma (AITL); (3) Anaplastic large T-cell lymphoma (ALCL), ALK+; (4) Anaplastic large T-cell lymphoma (ALCL), ALK-; (5) NK/T cell lymphoma(NKTCL); (6) Other subtypes of PTCL that the investigator thinks can be included in the group; 3. Patients treated with Liposomal Mitoxantrone Hydrochloride (Single or combination therapy); 4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2; 5. Expected survival = 3 months; 6. The following baseline laboratory criteria are required: Absolute neutrophil count (ANC) =1.5 x 10^9/L, Platelet count (PLT) =75 x 10^9/L, Hemoglobin(HB)= 80 g/L(Neutrophil count of patients with bone marrow involvement can be relaxed to = 1.0 x 10^9/L, the platelet count can be relaxed to=50 x 10^9/L, hemoglobin can be relaxed to = 75 g/L); 7. Total Serum creatinine (Scr) =1.5X upper limit of normal (ULN), Alanine aminotransferase (ALT), and aspartate aminotransferase (AST) =2.5X ULN (Patients with liver invasion =5X ULN), bilirubin (TBIL)=1.5X ULN. (Patients with liver invasion =3X ULN); 8. At least one tumor evaluation after medication; 9. Subjects fully understand and voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: 1. Histologically confirmed diagnosis of Hepatosplenic T-cell Iymphoma or primary cutaneous ?d T cell lymphoma; 2. Uncontrolled systemic diseases (such as unstable angina pectoris, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, serious history of pericardial disease and other cardiovascular diseases; uncontrolled hypertension, diabetes, etc); 3. Hypersensitivity to any study drug or its components; 4. Patients of childbearing age who are unwilling to take contraceptive measures; 5. Patients who participated in other interventional clinical studies at the same time; 6. Patients with other malignant tumors requiring treatment; 7. Unsuitable subjects for this study determined by the investigator.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
Overall survival;Safety;Progression-free survival;Duration of Response;Complete response rate;

Countries

China

Contacts

Public ContactMa Jun,Zhu Jun, Huang Huiqiang
majun0322@126.com+86 451 84883452

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026