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Peripheral T Cell LymphomaPhase 2NCT04457830

The Efficacy and Safety of F520 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).

A Phase 2 study testing F520 in people with Peripheral T Cell Lymphoma, run by Shandong New Time Pharmaceutical Co., LTD.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase II clinical study to evaluate the efficacy and safety of F520 for the treatment of relapsed and refractory peripheral T cell lymphoma (PTCL), and to evaluate the immunogenicity of F520. 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?
F520
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
No sites listed yet
Study dates
1 Nov 2020to 1 Jan 2023
Phase
Phase 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

  • Aged 18 years or older, male or female;
  • Histologically confirmed relapsed or refractory PTCL patients who had received systemic treatment at least once but had failed to; Relapsed / refractory is defined as follows:
  • Relapsed: patients who have new lesions at the primary site or other sites after reaching CR in the previous treatment; Refractory: patients who fail to reach PR in 2 cycles or CR in 4 cycles after first-line or above systemic treatment; if the best effect or end cause is PD, the number of cycles is not required;
  • ECOG score of 0-2;
  • Life expectancy≥3 months;
  • Agree to provide archived tumor tissue samples or fresh tissue samples, including enough samples to complete PD-L1 test;
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  • Computed tomography (ct) scans should show the presence of at least one of two vertical orientations; The tumor lesions that could be measured were defined, with the longest diameter of intranode lesion > 1.5cm, the shortest diameter of intranode lesion > 1.0cm and the longest diameter of extranode lesion > 1.0cm;
  • The functions of important organs meet the following requirements (drugs with any blood component and cell growth factor are not allowed to be used within 14 days before the first administration):
  • routine blood tests: hemoglobin ≥ 90 g/L, neutrophil ≥ 1.5 ×109/L, platelet ≥ 75×109/L; Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); If there is liver metastasis, TBIL ≤ 3 × ULN, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5×ULN; Thyroid function indicators: thyroid-stimulating hormone (TSH) are within the normal range or thyroid-stimulating hormone (TSH) are not within the normal range and free thyroxine (FT3/FT4) are within the normal range;
  • Sign the written informed consent, and be able to follow the visit and related procedures specified in the protocol.

Who cannot join

  • Diagnosed as vascular immunoblastic t-cell lymphoma (AITL) or adult t-cell lymphoma/leukemia(ATLL);
  • Patients with active central nervous system (CNS) infiltration, including invasion of brain parenchyma, meninges or compression of spinal cord;
  • Diagnosed as cutaneous extranodal nasal type T-cell lymphoma;
  • Immunohistochemistry confirmed PD-1 positive;
  • Patients with complicated diseases, including autoimmune disease, type I diabetes, hypothyroidism requiring hormone replacement (except Hashimoto's thyroiditis) and severe mental disease;
  • The patients received systemic corticosteroids (prednisone > 10 mg/day or equivalent dose) within 2 weeks before the first administration or patients who need systemic corticosteroids therapy during the study;
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  • The patients received radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy or systemic treatment of antibody drugs within 4 weeks before the first administration; the patients used monoclonal antibody coupled radionuclide or cytotoxin therapy within 10 weeks before the first administration; the toxicity of the previous anti-tumor treatment did not recover to ≤ level 1 (except hair loss);
  • Uncontrolled hypertension (systolic blood pressure > 180mmHg and/or diastolic blood pressure > 100mmHg);
  • Previous history of organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • The patients who had autologous hematopoietic stem cell transplantation within 3 months before the first administration;
  • Patients receiving any attenuated vaccine within 4 weeks before the first administration or during the study;
  • Patients who are allergic to macromolecular protein or anti-PD-1 antibody;
  • Patients who with previous or concurrent malignancies (except skin basal cell carcinoma and cervical carcinoma in situ, which have been cured for more than 3 years);
  • Had uncontrollable or serious cardiovascular diseases, the heart of New YorkNYHA standard grade 3-4 history of chronic heart failure, unstable angina, myocardial infarction and other cardiovascular diseases within 6 months before the first administration;
  • HIV positive patients, or active hepatitis (hepatitis B: hepatitis B five items and HBV-DNA, transaminase, etc., hepatitis C: HCV antibody and HCV RNA);
  • Patients who had been previously treated with any other investigational drugs/devices within 4 weeks before the first administration;
  • Patients with drug abuse history or alcohol addiction history within 6 months before the first administration;
  • Patients who were previously treated with anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody, anti-137 or anti CTLA-4 antibody (or any other antibodies acting on T cell co-stimulation or checkpoint pathway);
  • Patients with current or previous interstitial lung diseases (except for interstitial lung disease caused by radiotherapy and chemotherapy and currently without symptoms);
  • Active infections requiring systemic treatment;
  • Patients with active pulmonary tuberculosis;
  • pregnant or lactating women, female patients with pregnancy plan or male patients with such plan from the study period to 6 months after the last medication, who are unwilling to use an effective contraceptive measure (such as IUD or condom) approved by medicine during the trial period;
  • Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator.

About this study

Official title: A Phase 2, Open-label, Single-arm, Multicenter Study of the Efficacy and Safety of F520 in Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).

It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase II clinical study to evaluate the efficacy and safety of F520 for the treatment of relapsed and refractory peripheral T cell lymphoma (PTCL), and to evaluate the immunogenicity of F520.

Being tested
F520
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.

  • F520Drug

    3mg/kg every 3 weeks

Study groups in NCT04457830
Study groupRoleWhat they receive
Single armExperimentalNot described
Receives: Drug: F520

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR)

    To evaluate the efficacy of F520 as defined by objective response rate (evaluated by IRC) in patients with relapsed or refractory PTCL.

    Measured: Approximately 24 months

Secondary outcomes (7)

  1. Objective response rate (ORR)

    To evaluate the efficacy of F520 as defined by objective response rate (evaluated by investigator) in patients with relapsed or refractory PTCL.

    Measured: Approximately 24 months

  2. Completed response rate (CRR)

    To evaluate the efficacy of F520 as defined by completed response rate (evaluated by investigator/IRC) in patients with relapsed or refractory PTCL.

    Measured: Approximately 24 months

  3. Duration of response (DOR)

    To evaluate the duration of response (DOR) of F520 in patients with relapsed or refractory PTCL.

    Measured: Approximately 24 months

  4. Overall survival (OS)

    To evaluate the duration from the first administration to death because of any reason in patients with relapsed or refractory PTCL.

    Measured: Approximately 24 months

  5. Progression-free survival (PFS)

    To evaluate the efficacy of F520 as defined by progression-free survival, in patients with relapsed or refractory PTCL.

    Measured: Approximately 24 months

  6. Disease control rate (DCR)

    To evaluate the efficacy of F520 as defined by disease control rate, in patients with relapsed or refractory PTCL.

    Measured: Approximately 24 months

  7. Time to response (TTR)

    To evaluate the efficacy of F520 as defined by time to response in patients with relapsed or refractory PTCL.

    Measured: Approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start1 Nov 2020 (estimated)
  3. Primary completion31 Jul 2022 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
F520
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04457830
Sponsor's protocol ID
NTP-F520-002
Status last verified
Jul 2020
First submitted
1 Jul 2020
Last updated
22 Oct 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing F520 in people with Peripheral T Cell Lymphoma, run by Shandong New Time Pharmaceutical Co., LTD.

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 10 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

Results are not available in the source record.

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?

Objective response rate (ORR) (time frame: Approximately 24 months). 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 NCT04457830.

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 22 Oct 2020.

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