PLM60 for Peripheral T Cell Lymphoma (PTCL)

NCT ID: NCT03553914

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2025-01-31

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).

Detailed 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.

Conditions

Peripheral T Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

20 mg/m^2 dose group

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

Group Type: EXPERIMENTAL

PLM60

Intervention Type: DRUG

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

12 mg/m^2 dose group

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

Group Type: EXPERIMENTAL

PLM60

Intervention Type: DRUG

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

16 mg/m^2 dose group

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

Group Type: EXPERIMENTAL

PLM60

Intervention Type: DRUG

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

Interventions

PLM60

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

Intervention Type: DRUG

Eligibility Criteria

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Conjupro Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Officials

Role: STUDY_DIRECTOR

Conjupro Biotherapeutics, Inc.

Locations

Gabrail Cancer Center

Canton, Ohio, United States

Gabrial Cancer Center

Canton, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 18582570 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25034977 (View on PubMed)

Other Identifiers

PLM60-MC-1201

Identifier Type: -

Identifier Source: org_study_id