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Phase I/II Clinical Study of Mitoxantrone Hydrochloride Liposomes in Combination With Gemcitabine, Dexamethasone, and Cisplatin in Relapsed/Refractory Peripheral T-cell Lymphoma






Fecha inicio: 1/5/2022
Fecha reclutamiento:
Fecha final:
  Enfermedad: Oncology: Lymphoma, Non-Hodgkin's

To evaluate the safety, tolerability, efficacy mitoxantrone hydrochloride liposome in combination with gemcitabine, dexamethasone, and cisplatin in relapsed/refractory peripheral T-cell lymphoma

País: China
Estado: En proceso
Fase: I/II
Promotor: Peking Union Medical College Hospital, CAMS CSPC Pharmaceutical Group Co./CSPC Ouyi Pharmaceutical Co.
Población de pacientes: Patients with relapsed/refractory PTCL
Área terapéutica: Oncology

Criterios de inclusión:
Subjects fully understand and voluntarily participate in this study and sign informed consent Age =18, =75 years, no gender limitation Expected survival = 3 months; Histologically confirmed diagnosis of peripheral T-cell lymphoma, is one of the following subtypes (1) Peripheral T-cell lymphoma non-specific type (PTCL-NOS) (2) Angioimmunoblastic T-cell lymphoma (AITL) (3) Anaplastic large cell lymphoma (ALCL), ALK+ (4) Anaplastic large cell lymphoma (ALCL), ALK- (5) Other subtypes of PTCL that the researcher considered to be included in the group; The criteria for relapsed/refractory lymphoma: Relapsed lymphoma is defined as lymphoma that relapsed after a complete response (CR) was achieved with initial chemotherapy. Refractory lymphoma is diagnosed by meeting any of the following criteria: 1) tumor reduction < 50% or disease progression after 4 cycles of standard regimens of chemotherapy; 2) CR was achieved by standard chemotherapy, but relapse occurred within six months; 3) Two or more times of recurrence after CR; 4) Relapse after hematopoietic stem cell transplantation; There must be at least one evaluable or measurable lesion meeting lugano2014 criteria: for lymph node lesions, the length and diameter should be > 1.5cm; For non lymph node lesions, the length and diameter should be > 1.0cm; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2; Bone marrow function: Absolute neutrophil count (ANC) =1.5×109/L, Platelet count (PLT) =75×109/L, Hemoglobin(HB)= 80g/L(Bone marrow invasive patient ANC=1.0×109/L,PLT=50×109/L,HB=75 g/L) Liver and kidney function:Total bilirubin (TBIL) =1.5×upper limit of normal (ULN) , The liver invasion=3.0×ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5× ULN , The liver invasion=5.0×ULN; Serum creatinine (Scr) =1.5× ULN

Criterios de exclusión:
The subject had previously received any of the following anti-tumor treatments: Those who have previously received mitoxantrone or mitoxantrone liposomes; Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin is more than 550 mg/m2 (1 mg doxorubicin converted from other anthracycline drugs is equivalent to 2 mg epirubicin); Have received anti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drugs; Patients who have received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days of the first medication; Hypersensitivity to any study drug or its components; Non controlled systemic diseases (such as active infection, non controlled hypertension, diabetes, etc.) Heart function and disease meet one of the following conditions: Long QT c syndrome or QTc interval > 480 ms; Complete left bundle branch block, grade II or III atrioventricular block; Serious and uncontrolled arrhythmias requiring drug treatment; New York Heart Association grade = III; Cardiac ejection fraction (LVEF)< 50%; A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment. Baseline NT-proBNP is greater than 800pg/ mL, cTnI is greater than the normal upper limit of our center, and the retest in three days which is still higher than the above range. Hepatitis B, Hepatitis C infection in active stage (if there is a positive hepatitis B surface antigen or core antibody, additional test HBV DNA, Hepatitis B virus DNA more than 1x103 copies /mL excluded; If HCV anti-body is positive, add test for HCV RNA, and exclude HCV RNA over 1x103 copies /mL) Past or current co-occurrence of other malignancies (except effectively controlled non-melanoma cutaneous basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies effectively controlled without treatment within the past five years) Have primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment; Pregnant and lactating women and patients of childbearing age who do not want to use contraception; Conditions that other researchers deem inappropriate to participate in this study.

Género: Both
Edad: Adults; Older Adults
Medicación: Anticancer, antimetabolite; Antiviral, other Anticancer, alkylating Anti-inflammatory; Anticancer, other; Immunosuppressant Anticancer, other; Reformulation, conjugate, pegylated; Reformulation, optimized, liposomes
Duración del tratamiento: No disponible





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