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

NCT04457830 | Unknown Phase 2

• 1 other identifier: NTP-F520-002
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (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.

  Approximately 24 months

Secondary Outcomes (7)

• Objective response rate (ORR)

  Approximately 24 months

• Completed response rate (CRR)

  Approximately 24 months

• Duration of response (DOR)

  Approximately 24 months

• Overall survival (OS)

  Approximately 24 months

• Progression-free survival (PFS)

  Approximately 24 months

Study Arms (1)

Single arm

EXPERIMENTAL

Drug: F520

Interventions

F520 DRUG

3mg/kg every 3 weeks

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: F520

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: November 1, 2020
• Primary Completion: July 31, 2022
• Study Completion: January 1, 2023
• Last Updated: October 22, 2020

Record last verified: 2020-07