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WithdrawnNCT03553914Updated Oct 19, 2020

PLM60 for Peripheral T Cell Lymphoma (PTCL)

A Phase 1/2 interventional study of PLM60 in Peripheral T Cell Lymphoma, sponsored by Conjupro Biotherapeutics, Inc.. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Conjupro Biotherapeutics, Inc. · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
IND Inactive Status
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

Browse Lymphoma studies →

Lead sponsor

Conjupro Biotherapeutics, Inc. is the lead sponsor of 10 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    12 mg/m^2 dose group

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

    Drug: PLM60

  • Experimental
    16 mg/m^2 dose group

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

    Drug: PLM60

  • Experimental
    20 mg/m^2 dose group

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

    Drug: PLM60

Interventions

  • DrugPLM60

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 Months

  2. Overall response rate in patients with PTCL after treatment PLM60

    Assessing the overall response rate (ORR) by Lugano Classification

    Time frame: 19 months

07

Study locations

2 sites
  • Gabrail Cancer Center
    Canton, Ohio 44718, United States
  • Gabrial Cancer Center
    Canton, Ohio 44718, United States
08

References and documents

Publications

  • 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. PubMed 18582570 ↗
  • 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. PubMed 25034977 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03553914
Lead sponsor
Conjupro Biotherapeutics, Inc.
Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Responsible party
Sponsor
First posted
Jun 12, 2018
Start date
Jan 2021 (estimated)
Primary completion
Jan 2024 (estimated)
Completion
Jan 2025 (estimated)
Last update
Oct 19, 2020

Study contacts

Study Officials
study director · Conjupro Biotherapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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