A Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma

NCT03776279 | Unknown Phase 2

• 1 other identifier: PLM60-PTCL
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open, multi-center, phase II study to evaluate the efficacy and safety of Mitoxantrone Hydrochloride Liposome Injection in Relapsed or refractory peripheral t-cell and NK/T-cell lymphoma.

Conditions

Relapsed or Refractory Peripheral T-cell and NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The percentage of complete response (CR) and partial response (PR) in all the enrolled subjects from the date of the first administration (calculated by the optimum response during the entire study period)

  >4weeks

Secondary Outcomes (4)

• Duration of Response(DoR)

  >3 months

• Progression-free survival(PFS)

  3 years

• Overall survival(OS)

  3 years

• Disease control rate(DCR)

  3 years

Study Arms (1)

Mitoxantrone Hydrochloride Liposome Injection

EXPERIMENTAL

4 weeks is a treatment cycle, and the first day of each cycle is administered.

Drug: Mitoxantrone Hydrochloride Liposome Injection

Interventions

Mitoxantrone Hydrochloride Liposome Injection DRUG

Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 60min in 250 ml 5％ glucose injection on the first day during a treatment phase of 4 weeks.

Mitoxantrone Hydrochloride Liposome Injection

Eligibility Criteria

• Age: 18 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:
• Those who have fully understood the study and have signed the ICF.
• Male or female, aged 18 or above (including 18).
• Those with PTCL and NK/T-cell lymphoma confirmed by histopathological and/or cytological examination, 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)
• Enteropathy-associated T-cell lymphoma (EATCL, Type I (traditional type), Type II)
• Hepatosplenic γδ T-cell lymphoma (HSTCL, γδT) hOther non-Hodgkin's lymphomas from invasive T-cells (other than highly invasive cells) approved by the sponsor, who may be enrolled in the opinion of the investigator.
• Those receivd at least first-line standard treatment (including chemotherapy and autologous hematopoietic stem cell transplantation) If anthracycline or anthracycline-containing chemotherapy has been used in the past, the efficacy is assessed as response; if they were NK/T-cell lymphoma patients, they need to be treated with asparaginase (or pepsinase, L-asparaginase) treatment.
• Subjects who must provide the written pathological/histological diagnosis report during the screening period, and agree to provide the tumor tissue sections or fresh tumor tissues to the Center Laboratory for testing.
• Those with ECOG performance status score of 0 or 1.
• The estimated survival time was at least 12 weeks.

You may not qualify if:

• Subjects consistent with any one of the following conditions:
• Subjects in lymphoma leukemia (malignant cell proportion of \> 20% in bone marrow examination);
• 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);
• Those receiving autologous hematopoietic stem cell transplantation within 6 months;
• Those receiving allogeneic hematopoietic stem cell transplantation previously.
• Those receiving major surgery (the definition of major surgery shall refer to the Level 3 or 4 surgery stipulated in the Management Practices of Clinical Application of Medical Technology) within 4 weeks prior to enrollment or those who have not completely recovered from any previous invasive operation.
• Those who have not recovered from toxic response in the previous anti-tumor treatment (\>Grade 1 in NCI-CTCAE \[Version 4.03\], with the exception of hair loss and pigmentation.
• 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 with existing other cerebral/meningeal diseases.
• Subjects with uncontrolled hypertension (refers to systolic pressure of 180 mmHg and/or diastolic pressure of 100 mmHg after treatment).
• Subjects with active hemorrhagic disease.
• Subjects with active infection, including hepatitis B (positive hepatitis B virus surface antigen and hepatitis B virus DNA of more than 1,000 copies/mL) and hepatitis C (positive hepatitis C virus RNA).

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Huiqiang Huang, Doctor

CONTACT

020-87343350; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2018
• First Posted: December 14, 2018
• Study Start: April 2, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 14, 2018

Record last verified: 2018-12

Locations

CN (1)