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PLM60 for Peripheral T Cell Lymphoma (PTCL)

Primary Purpose

Peripheral T Cell Lymphoma

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PLM60

About this trial

This is an interventional treatment trial for Peripheral T Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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

Additional Inclusion Criteria for Phase 2:

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

Key Exclusion Criteria:

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

Sites / Locations

Gabrail Cancer Center
Gabrial Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

12 mg/m^2 dose group

16 mg/m^2 dose group

20 mg/m^2 dose group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Overall response rate in patients with PTCL after treatment PLM60

Assessing the overall response rate (ORR) by Lugano Classification

Secondary Outcome Measures

Full Information

NCT ID

NCT03553914

First Posted

May 1, 2018

Last Updated

October 14, 2020

Sponsor

Conjupro Biotherapeutics, Inc.

Collaborators

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03553914

Brief Title

PLM60 for Peripheral T Cell Lymphoma (PTCL)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Withdrawn

Why Stopped

IND Inactive Status

Study Start Date

January 2021 (Anticipated)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Conjupro Biotherapeutics, Inc.

Collaborators

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

12 mg/m^2 dose group

Arm Type

Experimental

Arm Description

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

Arm Title

16 mg/m^2 dose group

Arm Type

Experimental

Arm Description

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

Arm Title

20 mg/m^2 dose group

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PLM60

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of subjects experiencing AEs and SAEs after treatment with PLM60

Description

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

Time Frame

8 Months

Title

Overall response rate in patients with PTCL after treatment PLM60

Description

Assessing the overall response rate (ORR) by Lugano Classification

Time Frame

19 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 Additional Inclusion Criteria for Phase 2: 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 Key Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Study Officials

Organizational Affiliation

Conjupro Biotherapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Gabrail Cancer Center

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Gabrial Cancer Center

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18582570

Citation

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.

Results Reference

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PubMed Identifier

25034977

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.

Results Reference

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PLM60 for Peripheral T Cell Lymphoma (PTCL)

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