- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03553914
PLM60 for Peripheral T Cell Lymphoma (PTCL)
A Randomized Phase 1-2 Study of PLM60 in Patients With Peripheral T-Cell Lymphoma
Study Overview
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.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Canton, Ohio, United States, 44718
- Gabrail Cancer Center
-
Canton, Ohio, United States, 44718
- Gabrial Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 12 mg/m^2 dose group
Subjects will receive PLM60 at 12 mg/m^2 dose.
|
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.
|
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.
|
PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
8 Months
|
Overall response rate in patients with PTCL after treatment PLM60
Time Frame: 19 months
|
Assessing the overall response rate (ORR) by Lugano Classification
|
19 months
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLM60-MC-1201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral T Cell Lymphoma
-
The First Affiliated Hospital of Xiamen UniversityThe First Affiliated Hospital with Nanjing Medical University; Shanxi Province... and other collaboratorsRecruitingPeripheral T Cell Lymphoma | Relapsed Peripheral T-Cell Lymphoma | Refractory T-Cell LymphomaChina
-
National Cancer Centre, SingaporeMerck Sharp & Dohme LLC; National Medical Research Council (NMRC), SingaporeNot yet recruitingRefractory Peripheral T-Cell Lymphoma | Relapsed Peripheral T-Cell LymphomaSingapore
-
The Lymphoma Academic Research OrganisationCompletedRefractory Peripheral T-Cell Lymphoma | Relapsed Peripheral T-Cell LymphomaFrance, Belgium
-
Millennium Pharmaceuticals, Inc.CompletedRefractory Peripheral T-Cell Lymphoma | Relapsed Peripheral T-Cell LymphomaUnited States, France, Italy, Poland, United Kingdom, Belgium, Germany, Spain, Belarus, Israel, Portugal, Bulgaria, Turkey, Canada, New Zealand, Peru, Brazil, Russian Federation, Chile, Puerto Rico, Australia, Austria, Hungary, Nether... and more
-
University of Alabama at BirminghamTerminatedAnaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Peripheral T-cell Lymphomas | Adult T-cell Leukemia | Adult T-cell Lymphoma | Peripheral T-cell Lymphoma Unspecified | T/Null Cell Systemic Type | Cutaneous t-Cell Lymphoma With Nodal/Visceral DiseaseUnited States
-
Legend Biotech USA IncActive, not recruitingT-Cell Lymphoma | Peripheral T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Refractory | Cutaneous T-Cell Lymphoma Recurrent | Peripheral T-Cell Lymphoma RecurrentUnited States
-
Karyopharm Therapeutics IncTerminatedCutaneous T-cell Lymphoma (CTCL) | Peripheral T-cell Lymphoma (PTCL)Australia, Singapore
-
BeiGeneCompletedCutaneous T-cell Lymphoma | Anaplastic Large Cell Lymphoma | Angioimmunoblastic T-cell Lymphoma | Adult Nasal Type Extranodal NK/T-cell Lymphoma | Anaplastic Large Cell Lymphoma, ALK-Positive | Extranodal NK/T-cell Lymphoma, Nasal Type | Peripheral T Cell Lymphoma | Extranodal NK/T-cell Lymphoma | Peripheral... and other conditionsChina, Taiwan, Germany, France, Canada, Italy
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingAngioimmunoblastic T-cell Lymphoma | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | Enteropathy-Associated T-Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | Monomorphic Epitheliotropic Intestinal T-Cell Lymphoma | Follicular T-Cell Lymphoma | Nodal Peripheral T-Cell Lymphoma...United States
-
OnxeoTerminatedNon-Hodgkin's Lymphoma | Cutaneous T-Cell Lymphoma | Peripheral T-Cell LymphomaUnited States, Germany, Israel, France, Thailand
Clinical Trials on PLM60
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.TerminatedSmall Cell Lung CancerChina
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Not yet recruitingAdvanced Hepatocellular Carcinoma
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Unknown
-
The First Affiliated Hospital of Soochow UniversityRecruitingDiffuse Large B-Cell LymphomaChina