Overview

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.