Clinical Pharmacokinetics of Mitoxantrone Hydrochloride Liposome Injection in Recurrent/Refractory Lymphoma Subjects

NCT05173545 | Completed Phase 1

• 1 other identifier: PLM60-PK
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open, randomized parallel group design study to investigate the pharmacokinetic characteristics of Mitoxantrone Hydrochloride liposome injection in the treatment of relapsed/refractory lymphoma after the first administration, and the safety and efficacy.

Conditions

Recurrent/Refractory Lymphoma

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic indexes, Cmax Maximum concentration (Cmax)

  aximum concentration (Cmax) of Mitoxantrone Hydrochloride Liposome

  Up to 28 days

• Pharmacokinetic indexes, Tmax

  Time to Cmax (Tmax) of Mitoxantrone Hydrochloride Liposome

  Up to 28 days

• Pharmacokinetic indexes, Maximum concentration (Cmax,u)

  Maximum concentration (Cmax,u) of Mitoxantrone Hydrochloride Liposome

  Up to 28 days

Secondary Outcomes (1)

• progression-free survival(PFS)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first（assessed up to 100 months）

Other Outcomes (1)

• Number of participants with Adverse Events (AEs)

  From the initiation of the first dose to 28 days after the last dose

Study Arms (3)

Mitoxantrone Hydrochloride Liposome Injection（12 mg/m2）

EXPERIMENTAL

itoxantrone Hydrochloride Liposome Injection（12 mg/m2）

Drug: Mitoxantrone Hydrochloride Liposome Injection

Mitoxantrone Hydrochloride Liposome Injection（16 mg/m2）

EXPERIMENTAL

itoxantrone Hydrochloride Liposome Injection（16 mg/m2）

Drug: Mitoxantrone Hydrochloride Liposome Injection

Mitoxantrone Hydrochloride Liposome Injection（20mg/m2）

EXPERIMENTAL

itoxantrone Hydrochloride Liposome Injection（20 mg/m2）

Drug: Mitoxantrone Hydrochloride Liposome Injection

Interventions

Mitoxantrone Hydrochloride Liposome Injection DRUG

Every 28 days is a administration cycle, a total of 4 cycles.Until the subject's PD or intolerable or withdrawal (whichever occurs first). 5% Glucose Injection drugs dissolved in 250 ml, intravenous drip for 60 minutes.

Mitoxantrone Hydrochloride Liposome Injection（12 mg/m2）; Mitoxantrone Hydrochloride Liposome Injection（16 mg/m2）; Mitoxantrone Hydrochloride Liposome Injection（20mg/m2）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must satisfy all the following conditions before enrollment:
• Fully understand the clinical trail and sign the Informed Consent Form (ICF).
• Ages range from 18 to 70 years (including 18 and 70 years), men and women are not limited.
• Histopathologically and/or cytologically diagnosed relapsed/refractory lymphoma patients must undergo at least a first-line standard treatment for relapse or no remission and no better choice for advanced patients.
• ECOG≤2.
• The estimated survival time was at least 3 months.
• The screening period of laboratory examination meet the following conditions, and 7 days before hematological evaluation during screening，subjects did not receive growth factor (long-acting granulocyte colony-stimulating factor needs 2 weeks interval), platelet or granulocyte transfusion:
• WBC≥3.5×109/L
• ANC≥1.5×109/L
• PLT≥75×109/L
• Hb≥90 g/L
• TBil≤1.5×ULN,If elevated bilirubin is caused by lymphoma invading the liver, the total bilirubin is allowed to be less than 3 x ULN.
• ALT/AST≤2.5×ULN，If the elevation is caused by lymphoma invading the liver, allow it to be less than 5 x ULN.
• The toxicity of previous antineoplastic treatments was restored to ≤ 1 (except hair loss and pigmentation).
• Female subjects were HCG negative in urine or blood (excluding menopause and hysterectomy)，men and women of childbearing age of the subjects take effective contraception during the experiment and 30 days of the end of last treatment.

You may not qualify if:

• Subjects consistent with any one of the following conditions:
• Subjects are consistent with one of the following conditions in the previous anti-tumor treatment history:
• Those receiving Mitoxantrone or Liposome-entrapped Mitoxantrone previously.
• Those receiving treatment of Adriamycin or other anthracyclines previously, with the total cumulative dose of \> 360 mg/m2 (when converted to 1 mg Adriamycin, other anthracyclines shall be equivalent to 2 mg Epirubicin or 2 mg Pirarubicin or 2 mg Daunorubicin or 0.5 mg Idarubicin);
• Those receiving anti-tumor treatment (including chemotherapy, radiotherapy, hormone therapy or administration of TCM with anti-tumor activity) within 4 weeks prior to the first use of the study drug) or taking part in other clinical trials and accept medication in clinical trials;
• Those who have not yet fully recovered from previous surgical or invasive procedures.
• Those with other malignant tumors previously or currently (except the non-melanoma skin basal cell carcinoma under effective control, breast/cervical carcinoma in situ, and other malignant tumors not treated but under effective control in the past five years).
• Subjects with known or existing primary or metastatic central nervous system lymphoma or active brain metastasis
• Cardiac dysfunction
• Male: QTc\>450 ms, female: QTc\>470 ms when ECG examination in the Research Center during the screening period;
• Clinically significant arrhythmias, including but not limited to complete left bundle branch block, Degree II atrioventricular block and PR interval \> 250 ms;
• Any risk factor that might increase the QTc interval, e.g. hypokalaemia, inherited long-QT syndrome, with current administration of the drug for prolonging the QT interval or discontinuance for less than 15 days;
• Congestive heart failure of ≥Grade 2 in the New York Heart Association;
• Cardiac ejection fraction less than 50% or less than the lower limit of laboratory examination vale range of Research Center;
• Within six months prior to recruitment occurred myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinical history of severe pericardial disease, or electrocardiographic evidence of acute ischemia or abnormal active conduction system.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Guizhou Cancer Hospita

Guiyang, Guizhou, 550000, China

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yunhong Huang, Master

  Cancer Hospital of Guizhou Province

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: December 30, 2021
• Study Start: July 29, 2019
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: December 30, 2021

Record last verified: 2021-11

Locations

CN (1)