PLM60 for Peripheral T Cell Lymphoma (PTCL)

NCT03553914 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: PLM60-MC-1201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 1-2, randomized, multicenter, open label study of PLM60 administered via intravenous (IV) infusion in 28 day treatment cycles to adult participants with relapsed or refractory Peripheral T Cell Lymphoma (PTCL).

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Percentage of subjects experiencing AEs and SAEs after treatment with PLM60

  Percentage of subjects experiencing AEs and SAEs, by evaluating physical examinations, vital signs, ECOG score, ECGs, ECHO or MUGA scans, and clinical laboratory findings

  8 Months

• Overall response rate in patients with PTCL after treatment PLM60

  Assessing the overall response rate (ORR) by Lugano Classification

  19 months

Study Arms (3)

12 mg/m^2 dose group

EXPERIMENTAL

Subjects will receive PLM60 at 12 mg/m\^2 dose.

Drug: PLM60

16 mg/m^2 dose group

EXPERIMENTAL

Subjects will receive PLM60 at 16 mg/m\^2 dose.

Drug: PLM60

20 mg/m^2 dose group

EXPERIMENTAL

Subjects will receive PLM60 at 20 mg/m\^2 dose.

Drug: PLM60

Interventions

PLM60 DRUG

PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.

12 mg/m^2 dose group; 16 mg/m^2 dose group; 20 mg/m^2 dose group

Eligibility Criteria

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

You may qualify if:

• Signed informed consent prior to study-related procedures
• Patients with histologically confirmed relapsed or refractory PTCL, who were treated with at least 2 lines of standard therapy and for whom there is no known effective therapy.
• Recovered from all toxicity from prior anticancer therapy based on clinical evaluation/ judgement of the Investigator
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
• Participants who have sufficient baseline organ function by laboratory evaluations
• Left ventricular ejection fraction (LVEF) ≥ 50%
• Life expectancy ≥ 16 weeks
• Women of childbearing potential must have a negative pregnancy test prior to study entry, and agree to use adequate contraception from study entry through at least 3 months after the last dose of study drug
• A male participant must agree to use adequate contraception; or female sexual partner who uses adequate contraception measures from study entry through at least 3 months after the last dose of study drug
• Involved lymph nodes or masses should be measurable in at least 2 perpendicular dimensions and be ≥ 1.5 cm in the longest of the perpendicular dimensions (based on Lugano Classification)
• Agree to undergo pretreatment bone marrow biopsy and post treatment bone marrow biopsy when required to confirm response

You may not qualify if:

• Participants with a history of allergy to anthracyclines or liposomal drugs
• Prior treatment with mitoxantrone, any anthracycline, or anthacenedione
• Treatment with doxorubicin (with the exception of pegylated liposomal doxorubicin) with a total cumulative dose \> 300 mg/m2, or epirubicin with a total cumulative dose \> 500 mg/m2
• Investigational treatment within 4 weeks of the start of PLM60
• Prior allogeneic stem cell transplantation
• Current symptomatic (uncontrolled) central nervous system tumor involvement
• Certain types of cardiac impairment as defined in the protocol at the time of enrolment
• Any concurrent active malignancy or concurrent malignancy diagnosis with less than 12 months disease free interval
• Participants with evidence of an active infection
• Participants with active bleeding
• Participants who have had organ transplants

Sponsors & Collaborators

• Conjupro Biotherapeutics, Inc.: lead
• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: collaborator

Study Sites (2)

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Gabrial Cancer Center

Canton, Ohio, 44718, United States

Location

Related Publications (2)

• Li C, Cui J, Wang C, Li Y, Zhang H, Wang J, Li Y, Zhang L, Zhang L, Guo W, Wang Y. Encapsulation of mitoxantrone into pegylated SUVs enhances its antineoplastic efficacy. Eur J Pharm Biopharm. 2008 Oct;70(2):657-65. doi: 10.1016/j.ejpb.2008.05.019. Epub 2008 Jun 6.

  PMID: 18582570 BACKGROUND

• Yang J, Shi Y, Li C, Gui L, Zhao X, Liu P, Han X, Song Y, Li N, Du P, Zhang S. Phase I clinical trial of pegylated liposomal mitoxantrone plm60-s: pharmacokinetics, toxicity and preliminary efficacy. Cancer Chemother Pharmacol. 2014 Sep;74(3):637-46. doi: 10.1007/s00280-014-2523-8. Epub 2014 Jul 18.

  PMID: 25034977 BACKGROUND

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Study Officials

  Conjupro Biotherapeutics, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: June 12, 2018
• Study Start: January 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: October 19, 2020

Record last verified: 2020-10

Locations

US (2)