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

UNKNOWNPHASE2

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

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

NCT04457830•Shandong New Time Pharmaceutical Co., LTD

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 18 years or older, male or female;
•2. 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;
•3. ECOG score of 0-2;
•4. Life expectancy≥3 months;
•5. Agree to provide archived tumor tissue samples or fresh tissue samples, including enough samples to complete PD-L1 test;
•6. 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;
•7. 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;
•8. Sign the written informed consent, and be able to follow the visit and related procedures specified in the protocol.

Exclusion Criteria

•1. Diagnosed as vascular immunoblastic t-cell lymphoma (AITL) or adult t-cell lymphoma/leukemia(ATLL);
•2. Patients with active central nervous system (CNS) infiltration, including invasion of brain parenchyma, meninges or compression of spinal cord;
•3. Diagnosed as cutaneous extranodal nasal type T-cell lymphoma;
•4. Immunohistochemistry confirmed PD-1 positive;
•5. Patients with complicated diseases, including autoimmune disease, type I diabetes, hypothyroidism requiring hormone replacement (except Hashimoto's thyroiditis) and severe mental disease;
•6. 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;
•7. 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);
•8. Uncontrolled hypertension (systolic blood pressure \> 180mmHg and/or diastolic blood pressure \> 100mmHg);
•9. Previous history of organ transplantation or allogeneic hematopoietic stem cell transplantation;
•10. The patients who had autologous hematopoietic stem cell transplantation within 3 months before the first administration;
+13 more criteria

Key Dates

Start Date

November 1, 2020

Primary Completion Date

July 31, 2022

Completion Date

January 1, 2023

Last Updated

October 22, 2020

Enrollment

105

ESTIMATED participants

Conditions

Peripheral T Cell Lymphoma

Interventions

F520

DRUG

A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma

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RECRUITINGPHASE2

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

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T-cell LymphomaGraft Versus Host Disease+6 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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