Mitoxantrone Hydrochloride Liposomes in Combination With GDP in Relapsed/Refractory PTCL

• Status: Recruiting
• Trial end date: 2025-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open-label, single arm, multicenter clinical study to evaluate the safety, tolerability, efficacy mitoxantrone hydrochloride liposome in combination with gemcitabine, dexamethasone, and cisplatin in relapsed/refractory peripheral T-cell lymphoma

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborator: CSPC Ouyi Pharmaceutical Co., Ltd.
• Treatments: Dexamethasone; Gemcitabine; Mitoxantrone

Criteria

Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent

2. Age ≥18, ≤75 years, no gender limitation

3. Expected survival ≥ 3 months;

4. 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;

5. 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;

6. 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;

7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2；

8. 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)

9. 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

Exclusion Criteria:

1. The subject had previously received any of the following anti-tumor treatments:

1. Those who have previously received mitoxantrone or mitoxantrone liposomes;

2. 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);

3. 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;

4. Patients who have received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days of the first medication;

2. Hypersensitivity to any study drug or its components;

3. Non controlled systemic diseases (such as active infection, non controlled hypertension, diabetes, etc.)

4. Heart function and disease meet one of the following conditions:

1. Long QT c syndrome or QTc interval > 480 ms;

2. Complete left bundle branch block, grade II or III atrioventricular block;

3. Serious and uncontrolled arrhythmias requiring drug treatment;

4. New York Heart Association grade ≥ III;

5. Cardiac ejection fraction (LVEF)< 50%;

6. 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.

7. 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.

5. 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)

6. 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)

7. Have primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;

8. Pregnant and lactating women and patients of childbearing age who do not want to use contraception;

9. Conditions that other researchers deem inappropriate to participate in this study.