Peripheral T Cell LymphomaPhase 1/2NCT03553914
PLM60 for Peripheral T Cell Lymphoma (PTCL)
A Phase 1/2 study testing PLM60 in people with Peripheral T Cell Lymphoma, run by Conjupro Biotherapeutics, Inc. at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- PLM60
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2021to Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gabrail Cancer Center
Canton, Ohio, 44718
Gabrial Cancer Center
Canton, Ohio, 44718
About this study
Official title: A Randomized Phase 1-2 Study of PLM60 in Patients With Peripheral T-Cell Lymphoma
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.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- PLM60
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLM60Drug
PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.
| Study group | Role | What they receive |
|---|---|---|
| 12 mg/m^2 dose group | Experimental | Subjects will receive PLM60 at 12 mg/m^2 dose. Receives: Drug: PLM60 |
| 16 mg/m^2 dose group | Experimental | Subjects will receive PLM60 at 16 mg/m^2 dose. Receives: Drug: PLM60 |
| 20 mg/m^2 dose group | Experimental | Subjects will receive PLM60 at 20 mg/m^2 dose. Receives: Drug: PLM60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 Months
Overall response rate in patients with PTCL after treatment PLM60
Assessing the overall response rate (ORR) by Lugano Classification
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study startJan 2021 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: IND Inactive Status
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conjupro Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Study Officials, Study director, Conjupro Biotherapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03553914
- Sponsor's protocol ID
- PLM60-MC-1201
- Status last verified
- Oct 2020
- First submitted
- 1 May 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 18582570Yang 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 1-2 Study of PLM60 in Patients With Peripheral T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT03553914
- Acronym / sponsor ID
- PLM60-MC-1201
- Conditions
- Peripheral T Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IND Inactive Status
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Conjupro Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 12 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 12 mg/m^2 dose group | Experimental | Drug: PLM60Subjects will receive PLM60 at 12 mg/m^2 dose. |
| 16 mg/m^2 dose group | Experimental | Drug: PLM60Subjects will receive PLM60 at 16 mg/m^2 dose. |
| 20 mg/m^2 dose group | Experimental | Drug: PLM60Subjects will receive PLM60 at 20 mg/m^2 dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLM60PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles. | Drug | 12 mg/m^2 dose group, 16 mg/m^2 dose group, 20 mg/m^2 dose group |
Primary outcome
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
Overall response rate in patients with PTCL after treatment PLM60
Time frame: 19 months
Assessing the overall response rate (ORR) by Lugano Classification
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Background: PubMed 18582570Li 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.
- Background: PubMed 25034977Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Officials study director
Conjupro Biotherapeutics, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PLM60 in people with Peripheral T Cell Lymphoma, run by Conjupro Biotherapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects experiencing AEs and SAEs after treatment with PLM60 (time frame: 8 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03553914, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.