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Primary Central Nervous System LymphomaPhase 2NCT04457869

A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)

A Phase 2 study testing F520 in people with Primary Central Nervous System Lymphoma and Secondary Central Nervous System 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 The sponsor has not verified this record for over two years, so it may be out of date.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/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
F520
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 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

  • Male or female of 18 Years and older;
  • Pathologically confirmed PCNSL or SCNSL of primary testicular diffuse large B-cell lymphoma (PT-DLBCL) who failed or did not respond to at least 1 line of systemic therapy; Recurrence and refractory should meet the following definitions:
  • PCNSL patients: relapse is defined as the appearance of new lesions at the primary site or other sites after the standard treatment with MTX reaches complete remission (CR). Refractory patients were defined as those who did not reach PR in 2 cycles or CR in 4 cycles after standard treatment with MTX. If the best effect or end cause was PD, the number of courses was not required;
  • patients with SCNSL: Patients with relapsed/refractory primary testicular diffuse large B-cell lymphoma who must include central nervous system invasion. Relapse was defined as the patients who had been prevented or treated with MTX; refractory was defined as the patients who had received the latest chemotherapy regimen for 2 cycles without PR or 4 cycles without CR. if the best effect or end cause was PD, the number of courses was not required;
  • Measurable disease requirements on scans: subjects should have at least one measurable extranodal brain lesion more than 10×10mm;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0~2;
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  • Agree to provide archived tumor tissue specimens or fresh tissue specimens;
  • Life expectancy ≥ 3 months;
  • Adequate laboratory parameters during the screening period as evidenced by the following（No blood components and cell growth factors are allowed within 14 days prior to screening）:
  • routine blood tests: Absolute neutrophil count ≥1.5×109/L ;Platelets ≥100×109/L;Hemoglobin ≥ 9.0 g/dL; Liver function：Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), ALT and AST ≤2.5ULN; for subjects with liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5×ULN, Total bilirubin (TBIL) ≤3×upper limit of normal (ULN); Renal function CCr≤1.5×ULN，Creatinine clearance≥50 mL/min; Thyroid function indicators: thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are within the normal range or no clinical significant;
  • International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal;
  • Understand study procedures and contents, and voluntarily sign the written informed consent form.

Who cannot join

  • a）Patients with suspected or existing eye tumors; b）patients who cannot undergo MRI assessments c) PCNSL patients with systemic disease;
  • Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder (Except for mild cognitive impairment caused by tumor);
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast;
  • Patients with stroke within 6 months before the first dose (except for those with "multiple lacunar infarction" indicated by imaging examination, but no need for treatment) or with a history of intracranial hemorrhage (except for intracranial hemorrhage after surgery);
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 14 days before the first dose;
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  • Active infection（needing therapy） or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
  • Those who received systemic therapy of radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy, or antibody drugs within 4 weeks before the first dose; used monoclonal antibody coupled radionuclide or cytotoxic therapy within 10 weeks before the first dose; the toxicity of previous anti-tumor therapy has not recovered to ≤1 (except hair loss);
  • Patients who have a history of organ transplantation or allogeneic bone marrow transplantation or who have received auto stem cell transplantation or other severe immune defects within 3 months before the first dose;
  • Patients who are preparing for autologous stem cell transplantation.
  • Patients with active pulmonary tuberculosis;
  • Previous or simultaneous interstitial lung disease (except for interstitial lung disease caused by radiotherapy and chemotherapy and without symptoms at present);
  • Patients with active hepatitis;
  • Patients with HIV positive;
  • Patients received any other clinical trial drug / device treatment within 4 weeks before the first administration;
  • Patients with uncontrollable or serious cardiovascular diseases, cardiovascular diseases such as congestive heart failure, unstable angina pectoris, myocardial infarction and other cardiovascular diseases of NYHA grade II or above occurred within 6 months before the first dose; uncontrolled hypertension (systolic pressure ≥ 180mmhg and / or diastolic pressure ≥ 100mmhg);
  • Patients with drug abuse history or alcohol addiction history within 6 months before the study drug administration;
  • Patients with known previous allergies to macromolecular protein preparations or known to be allergic to anti-PD-1 / PD-L1 antibodies
  • Patients who received live attenuated vaccine within 4 weeks before the first dose (except inactivated influenza vaccine such as seasonal influenza vaccine for injection);
  • Female and male who have reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 6 months after receiving the last dose of study treatment.
  • The investigators judged that it was not suitable for the patients to participating in the study.

About this study

Official title: A Phase 2, Open-label, Single-arm, Multicenter Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)

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/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL).

Being tested
F520

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 NCT04457869
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) by Independent Review Committee (IRC) Independent Review Committee (IRC).

    Response assessment will be performed according to modified IPCG response. criteria on contrastenhanced cranial MRI-scans.

    Measured: Approximately 24 months

Secondary outcomes (5)

  1. Objective response rate (ORR) based on the investigator assessment.

    Response assessment will be performed according to modified IPCG response.

    Measured: Approximately 24 months

  2. Progression-free survival (PFS)

    Based on IRC and the investigator assessments.

    Measured: Approximately 24 months

  3. Duration of response (DOR)

    Based on IRC and the investigator assessments.

    Measured: Approximately 24 months

  4. Overall survival (OS)

    Measured: Approximately 24 months

  5. Safety of F520

    AE/SAE will be assessed by CTCAE v5.0

    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
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04457869
Sponsor's protocol ID
NTP-F520-003
Status last verified
Apr 2020
First submitted
1 Jul 2020
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
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 Primary Central Nervous System Lymphoma and Secondary Central Nervous System 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 12 inclusion and 21 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) by Independent Review Committee (IRC) Independent Review Committee (IRC). (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 NCT04457869.

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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