Status:
ACTIVE_NOT_RECRUITING
Clinical Study of Mitoxantrone Hydrochloride Liposome Injection vs. Chidamide in Patients With Relapsed/Refractory PTCL
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Peripheral T Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a randomized, open-label, active controlled, multi-center, phase 3 clinical study to compare the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with Chidamide in patients...
Detailed Description
This study is a randomized, open-label, positive control, multicenter, phase Ⅲ study to compare the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection with Chidamide in patients with...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- Age ≥18, ≤75 years, no gender limitation;
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2;
- Histopathologically confirmed Peripheral T -cell Lymphoma (PTCL) according to World Health Organization (WHO) criteria (version 2016), with the subtypes as follows:
- Peripheral T-cell lymphoma, unspecified (PTCL, NOS);
- Angioimmunoblastic T-cell lymphoma (AITL);
- ALK+ systematic anaplastic large T-cell lymphoma (ALCL, ALK+);
- ALK-systematic anaplastic large T-cell lymphoma (ALCL，ALK-);
- Extranobal NK/T cell lymphoma (nasal type) (NKTCL);
- Other subtypes of PTCL which are appropriate to be enrolled in the opinion of the investigator.
- Patients have relapsed or are refractory to at least one line of prior systemic therapy (anthracycline-containing regimen) for PTCL. Relapse is defined as recurrence after CR or progress after PR; refractory refers to the efficacy of 2 cycles of treatment is PD, or the efficacy of 4 cycles of treatment is SD;
- Subjects have at least one measurable lesion in accordance with the Lugano evaluation criteria (version 2014): the long axis of the lymph node shall be\>1.5 cm, the long axis of the extranodal lesions shall be\>1.0 cm.
- Subjects must provide a written pathology/histological diagnosis report during the screening period and must agree to provide a tumor tissue section or tumor/lymph node tissue specimen to be sent to the central laboratory.
- Life expectancy ≥ 12 weeks;
- During the screening period, the patients should meet the following requirements and have not received infusion of cell growth factor, platelet and granulocyte within 7 days of the hematology test; 1) Absolute value of neutrophils ≥ 1.5 × 109/L; absolute value of neutrophil ≥ 1.0 × 109/L in patients with involvement of bone marrow; 2) Hemoglobin ≥ 90 g/L (no red cell infusion within 14 days), hemoglobin ≥ 75 g/L in patients with involvement of bone marrow; 3) Platelet ≥ 75 × 109/L in patients without involvement of bone marrow; platelet ≥ 50 × 109/L in patients with involvement of bone marrow; 4) Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN) (total bilirubin ≤ 3 × ULN if bilirubin level increase is caused by lymphoma invading the liver); 5) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 × ULN; if the elevated level of AST or ALT is caused by liver involvement, both AST and ALT shall be ≤ 5 × ULN); 6) Creatinine \< 1.5 × ULN.
- Eligible fertile patients (male and female) must agree to use an effective method of contraception (hormonal or barrier or abstinence) with their partners from the study initiation until at least 7 months after the last treatment; women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment.
- Exclusion Criteria (Limit: 15,000 characters)
- Patients with leukemia type PTCL (adult T-cell leukemia/lymphoma, etc.), or in lymphoma leukemia stage (malignant cell proportion of \> 20% in bone marrow examination); or with central nervous system (CNS) involvement, or with complicated of hemophagocytic syndrome.
- History of allergy and contraindications to the same class and excipients of the experimental drug.;
- Patients have one of the following conditions in the previous anti-tumor treatments:1) Patients received mitoxantrone or liposome mitoxantrone within 6 months;2) Patients who was treated with Chidamide and the efficacy was evaluated as PD; Patients who was treated with Chidamide within 6 months (if the patients have been treated with Chidamide for no more than 2 weeks, had no clear evidence of PD and no intolerable toxicity during the treatment period, and discontinued therapy for other reasons, may be considered with the investigator's consent);3) Those receiving treatment of Adriamycin or other anthracyclines previously, with the total cumulative dose of \> 360 mg/m2 (other anthracycline drugs: 1 mg of epirubicin/pyramycin/daunorubicin is equivalent to 0.5 mg of doxorubicin, 1 mg of deoxydaunorubicin is equivalent to 2 mg of doxorubicin);4) Those received anti-tumor treatment, including cytotoxic chemotherapy, radiotherapy and targeted drug therapy within 4 weeks prior to the first use of the study drug, or immunomodulators (thalidomide, lenalidomide) within 3 weeks; or hormone or herbal therapy with lymphoma as indication within 2 weeks;
- Participated in other clinical studies and received therapy within 4 weeks prior to the first administration of the study drug;
- Those received allogeneic hematopoietic stem cell transplantation previously and autologous hematopoietic stem cell transplantation within 6 months;
- Adverse reactions from the previous anti-tumor treatment have not yet recovered (\>Grade 1 in NCI-CTCAE \[Version 4.03\], with the exception of hair loss and pigmentation);
- Subjects with the impaired cardiac function or significant heart disease, including but not limited to:1) Myocardial infarction, congestive heart failure and viral myocarditis occurred 6 months before screening; heart disease with symptoms requiring treatment and intervention, such as unstable angina, arrhythmia, etc.;2) Congestive heart failure of ≥Grade 2 according to the New York Heart Association Classification;3) Cardiac ejection fraction less than 50% or less than the lower limit of the reference range of the laboratory examination used in the Research Center;4) Persistent myocardial disease;5) QTc \> 450 milliseconds, or congenital long QT syndrome.
- Patients with active infection, including hepatitis B (positive hepatitis B virus surface antigen and HBV-DNA titer higher than the upper limit of the reference range) and hepatitis C (positive hepatitis C virus RNA and HCV-RNA titer higher than the upper limit of the reference range);
- History of severe autoimmune disease and immunodeficiency, including positive for human immunodeficiency virus (HIV); or other acquired or congenital immune deficiency diseases; or a history of organ transplantation;
- Patients with other malignant tumors in the past five years (except the cured non-melanoma skin basal cell carcinoma and cervical carcinoma in situ);
- Major surgery within 6 weeks prior to screening. or have a surgical schedule during the study period;
- Patients have significant gastrointestinal disorders that may affect the ingestion, transportation, or absorption of the drug (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.) during the screening period;
- Patients have uncontrolled hypertension (systolic pressure of 180 mmHg and/or diastolic pressure of 110 mmHg after treatment); or type 2 diabetes that cannot be controlled by oral hypoglycemic drugs or insulin therapy;
- The patients had a history of active bleeding within the previous 3 months before the screening;
- History of mental illness or history of drug abuse or dependence;
- Pregnant or lactating women;
- Not suitable for this study as determined by the investigator due to other reasons.
Exclusion
Key Trial Info
Start Date :
April 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2028
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT04668690
Start Date
April 13 2021
End Date
December 30 2028
Last Update
May 31 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060