Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03553914
Other study ID # PLM60-MC-1201
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2021
Est. completion date January 2025

Study information

Verified date October 2020
Source Conjupro Biotherapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2025
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States Gabrail Cancer Center Canton Ohio
United States Gabrial Cancer Center Canton Ohio

Sponsors (2)

Lead Sponsor Collaborator
Conjupro Biotherapeutics CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8 Months
Primary Overall response rate in patients with PTCL after treatment PLM60 Assessing the overall response rate (ORR) by Lugano Classification 19 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT04390737 - Evaluate the Safety and Clinical Activity of HH2853 Phase 1/Phase 2
Recruiting NCT05559008 - A Umbrella Study in R/R PTCL Guided by Molecular Subtypes Phase 1/Phase 2
Recruiting NCT06083701 - Phase I/II Study of Linperlisib Plus Chidamide for R/R Peripheral T-cell Lymphoma: a Prospective, Multi-center Study Phase 1/Phase 2
Not yet recruiting NCT02856997 - Chidamide With ICE Regimen for Relapsed/Refractory Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04083495 - CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma Phase 2
Not yet recruiting NCT05979792 - Clinical Study of CD7 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory CD7-positive Peripheral T Cell Lymphoma Early Phase 1
Recruiting NCT04984837 - Study of Lacutamab in Peripheral T-cell Lymphoma Phase 2
Recruiting NCT06072131 - To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL Phase 3
Completed NCT01716806 - A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) Phase 2
Terminated NCT03947255 - A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma Phase 2
Recruiting NCT04028440 - γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Early Phase 1
Not yet recruiting NCT05923502 - (CHANT)Real World Study of Duvelisib in the Treatment of Non-Hodgkin's Lymphoma (NHL)
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Recruiting NCT05883449 - Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL Phase 2
Active, not recruiting NCT03586999 - Nivolumab With Standard of Care Chemotherapy for Peripheral T Cell Lymphomas Phase 1/Phase 2
Recruiting NCT04489264 - The Role of Consolidative Autologous Stem Cell Transplantation After First-line Therapy in Peripheral T Cell Lymphoma
Recruiting NCT06151106 - Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma Phase 2
Recruiting NCT02753543 - Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma Phase 2
Not yet recruiting NCT06089941 - Circulating Tumor DNA Sequencing in Patients With Peripheral T-cell Lymphomas