PLM60 for Peripheral T Cell Lymphoma (PTCL)

Peripheral T Cell Lymphoma Clinical Trial

Official title:

A Randomized Phase 1-2 Study of PLM60 in Patients With Peripheral T-Cell Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03553914
• Other study ID #: PLM60-MC-1201
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 2021
• Est. completion date: January 2025

Study information

• Verified date: October 2020
• Source: Conjupro Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

The study is designed to identify and characterize the safety, tolerability, efficacy, and the PK profile of PLM60 in patients with relapsed or refractory PTCL. Phase 1 will explore multiple dose levels and select a single dose level in Phase 2 to more effectively assess efficacy in the PTCL population. It is anticipated that up to approximately 30 participants will be enrolled during Phase 1. The actual number enrolled, however, will depend on the number of dose-limiting toxicity (DLT)-evaluable participants that complete the first cycle of therapy. Phase 2 will enroll up to 34 participants at the RP2D, some of whom will have been enrolled during Phase 1. Consequently, up to approximately 55 participants will be treated in the study as a whole.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Signed informed consent prior to study-related procedures

2. 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.

3. Recovered from all toxicity from prior anticancer therapy based on clinical evaluation/ judgement of the Investigator

4. Participants must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.

5. Participants who have sufficient baseline organ function by laboratory evaluations

6. Left ventricular ejection fraction (LVEF) = 50%

7. Life expectancy = 16 weeks

8. 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

9. 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

Additional Inclusion Criteria for Phase 2:

1. 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)

2. Agree to undergo pretreatment bone marrow biopsy and post treatment bone marrow biopsy when required to confirm response

Key Exclusion Criteria:

1. Participants with a history of allergy to anthracyclines or liposomal drugs

2. Prior treatment with mitoxantrone, any anthracycline, or anthacenedione

3. 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

4. Investigational treatment within 4 weeks of the start of PLM60

5. Prior allogeneic stem cell transplantation

6. Current symptomatic (uncontrolled) central nervous system tumor involvement

7. Certain types of cardiac impairment as defined in the protocol at the time of enrolment

8. Any concurrent active malignancy or concurrent malignancy diagnosis with less than 12 months disease free interval

9. Participants with evidence of an active infection

10. Participants with active bleeding

11. Participants who have had organ transplants

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T Cell Lymphoma

Intervention

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

Locations

Country	Name	City	State
United States	Gabrail Cancer Center	Canton	Ohio
United States	Gabrial Cancer Center	Canton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Conjupro Biotherapeutics	CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Overall response rate in patients with PTCL after treatment PLM60	Assessing the overall response rate (ORR) by Lugano Classification	19 months