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Primary Central Nervous System LymphomaPhase 2NCT05600660

Orelabrutinib,Rituximab and Methotrexate in Newly Diagnosed Primary Central Nervous System Lymphoma

A Phase 2 study testing Orelabrutinib, Rituximab and Methotrexate in people with Primary Central Nervous System Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy（Orelabrutinib, Rituximab and Methotrexate）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Central Nervous System Lymphoma
What is being tested?
Orelabrutinib, Rituximab and Methotrexate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteChina
Study dates
1 Aug 2022to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed Primary Central Nervous System (CNS) lymphoma Age range 18-75 years old.
  • Eastern Cooperative Oncology Group performance status 0 to 3.
  • Previously untreated. Patients treated with steroid alone are eligible.
  • Measurable disease was defined as at least ≥1.0cm in short-diameter by MRI.
  • Life expectancy of ≥ 3 months (in the opinion of the investigator).
  • Participants must be able to understand and be willing to sign a written informed consent document.
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  • Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 6 months after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 6 months after the last dose.
  • Women of childbearing potential must have a negative plasma pregnancy test upon study entry.
  • Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min;Serum creatinine ≤ 2 times the upper limit of normal.
  • Adequate liver functions: Transaminase (AST/ALT) < 3 X upper normal value \& Bilirubin < 2 X upper normal value.
  • Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL.
  • Must be able to tolerate lumbar puncture and MRI/CT.
  • Ability to swallow oral medications.

Who cannot join

  • Patient with systemic, non-CNS lymphoma metastatic to the CNS.
  • Patient is concurrently using other approved or investigational antineoplastic agents.
  • Presence of active hepatitis B virus(HBV) infection (HBsAg positive and HBV-DNA≥ 104), hepatitis C virus(HCV) infection, acquired and congenital immunodeficiency diseases include but not limited to HIV.
  • Patient is allergic to components of the study drug.
  • Patient has an active concurrent malignancy requiring active therapy.
  • Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, uncontrolled congestive heart failure, uncontrolled hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening.
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  • Patient is known to have an uncontrolled active systemic infection.
  • Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
  • Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive plasma human chorionic gonadotropin(hCG) laboratory test of > 5 mIU/mL.
  • The patient is unwell or unable to participate in all required study evaluations and procedures.
  • Drug abuse, medical, psychological or social conditions which may interfering with subjects' participation in the study or evaluation of the results.
  • History of intracranial hemorrhage or clinically significant stroke within 6 months prior to first day of study treatment
  • History of significant gastrointestinal disease that would limit absorption of oral medications.
  • Warfarin or any other Coumadin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Use of low molecular weight heparin and novel oral anticoagulants (eg. rivaroxaban, apixaban) is permitted if required.
  • Concurrent use of a moderate or strong inhibitor or inducer of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers prior to starting the study drug.
  • Known bleeding diathesis (e.g. von Willebrand's disease), hemophilia, or active bleeding.
  • History of invasive fungal infection, including invasive aspergillosis, or known active tuberculosis.
  • Patients considered unsuitable to participate in the study by the researchers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenbin Qian, prof. contact

+8613605801032

qianwb@zju.edu.cn

Xianggui Yuan, MD contact

+8613989883884

yuanxg@zju.edu.cn

China1 site, 1 recruiting

  • 2nd Affiliated Hospital, School of Medicine, Zhejiang University

    Hanzhou, Zhejiang, 310009

    Wenbin Qian, PhD,MD, +8613605801032, qianwb@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Orelabrutinib, Rituximab and Methotrexate (OR-MTX) in Newly Diagnosed Primary Central Nervous System Lymphoma: a Single Arm, Multicenter, Phase 2 Study

It is a single arm, multicenter, phase 2 study to explore the efficacy and safety study of OR-MTX chemotherapy（Orelabrutinib, Rituximab and Methotrexate）as first-line regimens in the treatment of newly diagnosed primary central nervous system lymphoma. Objective response rate is the primary endpoint.

Read the detailed description

This is a single arm, multicenter, phase 2 study designed to evaluate the efficacy and safety of Orelabrutinib, rituximab and methotrexate as first-line regimens in the treatment of newly primary central nervous system lymphoma. A total of 28 patients plan to participate in this study to receive a total 6 cycles of induction chemotherapy followed by Orelabrutinib maintenance chemotherapy up to one year. After 6 cycles of induction chemotherapy, autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be performed for transplantation eligible patients . Follow-ups should be taken up to the first 2 years. The primary endpoint is objective response rate (ORR) and secondary endpoint includes Progression free survival (PFS), overall survival (OS), and adverse events.

Being tested
Orelabrutinib, Rituximab, Methotrexate
Keywords
Primary Central Nervous System Lymphoma, Orelabrutinib, Methotrexate, Lenalidomide

What participants receive

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

  • OrelabrutinibDrug

    Orelabrutinib will be given as 150 mg/d orally 72h after MTX infusion or MTX clearance, every 21 days for 6 cycles during induction treatment.

    Daily Orelabrutinb will be administered as maintenance treatment for up to 1 year or until disease progression, intolerable toxicity, death, informed consent withdrawal or lost of follow up (whichever occurs first).

  • RituximabDrug

    375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy.

  • MethotrexateDrug

    3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.

Study groups in NCT05600660
Study groupRoleWhat they receive
OR-MTXExperimentalExperimental arm will be treated with OR-MTX regimen(Orelabrutinib plus Rituximab and Methotrexate) for 6 cycles as initiate induction. After 6 cycles of induction chemotherapy, autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be performed for transplantation eligible patients . Thereafter, Orelabrutinib maintenance chemotherapy will be given up to one year. Follow-ups should be taken up to the first 2 years. The primary endpoint is objective response rate (ORR) and secondary endpoint includes Progression free survival (PFS), overall survival (OS), and adverse events.
Receives: Drug: Orelabrutinib; Drug: Rituximab; Drug: Methotrexate

What is being measured

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

  1. Objective response rate(ORR)

    The objective response rate is defined as the proportion of patients with a response of complete response(CR) or partial response(PR).

    Measured: At the end of Cycle 6 chemotheray (each cycle is 21 days)

Secondary outcomes (2)

  1. Progression free survival

    From date of patients sign informed consent until the date of progression or death or the date of last follow-up time, whichever came first, assessed up to 2 years

    Measured: 2years

  2. Treatment-related adverse events

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 1 year

Timeline

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

  1. First posted31 Oct 2022
  2. Study start1 Aug 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (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
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05600660
Sponsor's protocol ID
2022-0407
Status last verified
Oct 2022
First submitted
27 Oct 2022
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xiao XB, Weng YQ, Jiang HW, Li X, Xie J, Bao CQ, Qian WB. Orelabrutinib combined with rituximab and high-dose methotrexate as induction therapy in newly diagnosed primary central nervous system lymphoma. Invest New Drugs. 2025 Jun;43(3):679-686. doi: 10.1007/s10637-025-01548-1. Epub 2025 May 27.

    PubMed 40425940

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orelabrutinib, Rituximab and Methotrexate in people with Primary Central Nervous System Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 18 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: looking for participants now, as of the sponsor's last update on 8 Nov 2022. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wenbin Qian, prof. (+8613605801032, qianwb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate(ORR) (time frame: At the end of Cycle 6 chemotheray (each cycle is 21 days)). 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 NCT05600660, which also lists 1 linked publication.

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 8 Nov 2022.

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