Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

PLM60 for Peripheral T Cell Lymphoma (PTCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553914
Recruitment Status : Suspended (IND Inactive Status)
First Posted : June 12, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Information provided by (Responsible Party):
Conjupro Biotherapeutics

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).

Condition or disease Intervention/treatment Phase
Peripheral T Cell Lymphoma Drug: PLM60 Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 1-2 Study of PLM60 in Patients With Peripheral T-Cell Lymphoma
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 12 mg/m^2 dose group
Subjects will receive PLM60 at 12 mg/m^2 dose.
Drug: PLM60
PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.

Experimental: 16 mg/m^2 dose group
Subjects will receive PLM60 at 16 mg/m^2 dose.
Drug: PLM60
PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.

Experimental: 20 mg/m^2 dose group
Subjects will receive PLM60 at 20 mg/m^2 dose.
Drug: PLM60
PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.




Primary Outcome Measures :
  1. Percentage of subjects experiencing AEs and SAEs after treatment with PLM60 [ Time Frame: 8 Months ]
    Percentage of subjects experiencing AEs and SAEs, by evaluating physical examinations, vital signs, ECOG score, ECGs, ECHO or MUGA scans, and clinical laboratory findings

  2. Overall response rate in patients with PTCL after treatment PLM60 [ Time Frame: 19 months ]
    Assessing the overall response rate (ORR) by Lugano Classification



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553914


Locations
Layout table for location information
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Gabrial Cancer Center
Canton, Ohio, United States, 44718
Sponsors and Collaborators
Conjupro Biotherapeutics
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Publications:
Layout table for additonal information
Responsible Party: Conjupro Biotherapeutics
ClinicalTrials.gov Identifier: NCT03553914     History of Changes
Other Study ID Numbers: PLM60-MC-1201
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: June 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin