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Primary Central Nervous System LymphomaPhase 2NCT06454266

First-line Treatment of PCNSL With the Combination of Orelabrutinib, Rituximab, and Methotrexate (ORM Regimen)

A Phase 2 study testing ORM regimen in people with Primary Central Nervous System Lymphoma, run by Ningbo No. 1 Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Exploring the efficacy and safety of first-line treatment of primary central nervous system lymphoma with the combination of orelabrutinib, rituximab and methotrexate (ORM regimen). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Primary Central Nervous System Lymphoma
What is being tested?
ORM regimen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
28 Dec 2021to 25 Jul 2024
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of primary central nervous system lymphoma (PCNSL) of B cell origin，confirmed by pathology (histology or cytology).
  • The patient voluntarily signs the informed consent form.
  • ECOG≤3 points.
  • According to the judgment of the researcher, the expected survival period is more than 3 months.
  • Have measurable lesions, and brain contrast-enhanced MRI shows solid lesions (>10*10mm) ; for those with only meningeal lesions, cytological examination of cerebrospinal fluid (CSF) is required to confirm lymphoma cells and/or imaging findings and CSF examination was consistent.
  • No previous systemic treatment for lymphoma, except corticosteroids;
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  • Bone marrow and organ function meet the following standards (no blood transfusion, no use of G-CSF, no use of drug correction within 14 days before screening):
  • ① Bone marrow function: Absolute value of neutrophils ≥1.5×109/L, platelets
  • 80×109/L, hemoglobin ≥80g/L;
  • Liver function: serum total bilirubin ≤1.5×ULN (≤3.0×ULN, if there is liver metastasis ); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5.0 × ULN, if there is liver metastasis); ③ Coagulation function: International normalized ratio (INR) and activated partial thrombin time ≤ 1.5 × ULN ;
  • Renal function: Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 60 mL/min (male: Cr (ml/min) = (140-age) × weight (kg) / 72 × serum creatinine concentration (mg/dl) ); Female: Cr (ml/min) = (140-age) × weight (kg)/85 × serum creatinine concentration (mg/dl)).
  • Female subjects of childbearing age and male subjects with childbearing potential who have no childbearing plans with their partners during the study and within 3 months after discontinuing treatment must take one of the following measures during the entire study and within 3 months of discontinuing treatment. Effective contraception: abstinence, physical contraception (such as ligation, condoms, etc.), and the use of hormonal contraceptives should be started at least 3 months before the first dose of medication. Male subjects are prohibited from donating sperm within 3 months from the start of treatment to the end of treatment. The patient or legal guardian voluntarily signed the informed consent form.
  • Good compliance and willingness to comply with visit schedule, dosing plan, laboratory examinations and other test steps.

Who cannot join

  • The pathological diagnosis was T-cell lymphoma;
  • Have other tumors that require treatment;
  • Uncontrollable active infection;
  • Have uncontrollable or important cardiovascular diseases, including (but not limited to):
  • Any of the following occurring within 6 months before the first dose Conditions: congestive heart failure (NYHA class III or IV), myocardial infarction, unstable angina, or arrhythmia requiring treatment at screening, left ventricular ejection fraction (LVEF) <50%;
  • Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy); ③ History of clinically significant QTc phase prolongation, II degree type II atrioventricular conduction resistance lag or III degree atrioventricular block or QTc interval (F method) >470msec (female) or >480msec (male); ④ Atrial fibrillation (EHRA grade ≥ 2b); ⑤ Uncontrollable hypertension, as determined by the researcher were judged not to be suitable to participate in this study.
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  • Suffering from active hepatitis B or C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, chronic hepatitis B carriers with HBV-DNA ≥ the detection limit of each center; hepatitis C: HCVRNA positive) or syphilis . Note: Inactive HBV surface antigen (HBsAg) carriers, subjects with active HBV infection and long-lasting anti-HBV suppression (HBV DNA <detection limit of each center), and subjects who have been cured of HCV can be enrolled.
  • HIV-infected patients;
  • Have ever received an organ transplant or allogeneic stem cell transplant.
  • For female subjects, currently in pregnancy or lactation.
  • Those who have previously or currently have pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, etc., and are judged by the researcher to be unsuitable to participate.
  • There have been autoimmune diseases requiring systemic treatment (i.e., disease-modifying antirheumatic drugs, hormones or immunosuppressants) in the past 2 years, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, etc. Rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-associated vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. The following situations are allowed: autoimmune hypothyroidism or type I diabetes under stable treatment, hormone replacement therapy (such as thyroxine, insulin, or physiological hormone supplementation due to adrenal or pituitary insufficiency) is not considered systemic therapy and is allowed Join the group.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, 315010

Other trials in China

About this study

Official title: Exploration of the Efficacy and Safety of Orelabrutinib Combined With Rituximab and Methotrexate (ORM Regimen) in the First-line Treatment of Primary Central Nervous System Lymphoma

Exploring the efficacy and safety of first-line treatment of primary central nervous system lymphoma with the combination of orelabrutinib, rituximab and methotrexate (ORM regimen).

Read the detailed description

This is an open, single arm, single center clinical study. Untreated primary central nervous system lymphoma patients sign an informed consent form and meet all inclusion criteria. The subjects received treatment with the ORM regimen every 21 days for a total of 6 cycles.

The main purpose is to evaluate the anti-tumor activity (ORR) of the first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen).

Secondary purpose:

  1. Evaluate the safety and tolerability of first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen).
  2. Other efficacy evaluations of the first-line treatment of primary central nervous system lymphoma with the combination of otinib, rituximab, and methotrexate (ORM regimen) include CR, DOR, DCR, and PFS.
  3. Evaluate the peripheral blood and cerebrospinal fluid pharmacokinetic characteristics of obrutinib and methotrexate.

The exploratory purpose is to investigate the relationship between the dynamic changes of cerebrospinal fluid ctDNA before and after treatment and the efficacy and prognosis.

Being tested
ORM regimen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ORM regimenDrug

    Also called Orelabrutinib, Rituximab and Methotrexate

    The subjects received ORM regimen treatment every 21 days for a total of 6 cycles. The specific medication is as follows " Obutinib tablets 150mg qd d1-21 (suspended 2 days before MTX use until MTX drops to safe concentration) Rituximab 375mg/m2, d1 Methotrexate 3g/m2, d2

Study groups in NCT06454266
Study groupRoleWhat they receive
ORM regimen(Orelabrutinib, Rituximab and Methotrexate)ExperimentalThe subjects received ORM regimen treatment every 21 days for a total of 6 cycles.
Receives: Drug: ORM regimen

What is being measured

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

  1. Overall response rate

    Proportion of CR and PR subjects will be assessed at 8 courses

    Measured: up to 8 months

Secondary outcomes (4)

  1. Progress free survival time

    To measure the duration of response over a follow-up period of 36 months

    Measured: up to36 months

  2. Overall survival

    OS will be assessed from the first receptor given to death or last follow-up

    Measured: up to36 months

  3. Adverse events profile

    Number of participants with adverse events. Freguencies of toxicities based on the NCl Common Terminology Critera for AdverseEvents (CTCAE), version 5.0 will be tabulated.

    Measured: up to 8 months

  4. MRD defined by cerebrospinal fluid ctDNA

    Dynamic changes of cerebrospinal fluid ctDNA before and after treatment.

    Measured: up to 8 months

Timeline

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

  1. First posted12 Jun 2024
  2. Study start28 Dec 2021
  3. Primary completion30 Jun 2024
  4. Study completion25 Jul 2024

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
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06454266
Sponsor's protocol ID
Ningbo103
Status last verified
Jul 2024
First submitted
5 May 2024
Last updated
30 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ORM regimen in people with Primary Central Nervous System Lymphoma, run by Ningbo No. 1 Hospital at 1 site in China.

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 13 inclusion and 12 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: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall response rate (time frame: up to 8 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 NCT06454266.

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 30 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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