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NCT04947319RECRUITINGIRB Ready

Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)

Sponsored by Ono Pharmaceutical Co. Ltd

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 112 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study will evaluate the efficacy, safety, and pharmacokinetics of tirabrutinib monotherapy in patients with relapsed or refractory PCNSL (Part A), and tirabrutinib in combination with one of two different high dose methotrexate based regimens (methotrexate/ temozolomide/rituximab or rituximab/methotrexate/procarbazine/ vincristine) as first line therapy in patients with newly diagnosed, treatment naΓ―ve PCNSL (Part B)

Who Can Participate

Inclusion Criteria

(Part A) 1. Written informed consent by the patient prior to screening 2. Patients aged β‰₯ 18 years on the day of consenting to the study 3. Pathologic diagnosis of PCNSL 4. Relapse or refractory PCNSL with at least one prior high dose methotrexate (HD-MTX) based therapy for PCNSL 5. Measurable brain lesion with a minimum diameter \> 1.0 cm in gadolinium enhanced magnetic resonance imaging (MRI) performed within 14 days before starting tirabrutinib treatment 6. Eastern Cooperative Oncology Group performance score (ECOG PS) of 0, 1 or 2 7. Life expectancy of at least 3 months 8. Adequate bone marrow, renal, and hepatic function Inclusion Criteria (Part B) 1. Written informed consent by the patient prior to screening 2. Patients aged β‰₯ 18 years on the day of consenting to the study 3. Pathologic diagnosis of PCNSL within the past 3 months 4. No prior anti-tumor treatments for PCNSL 5. Patients who, in the opinion of the Investigator, are suitable to receive treatment

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

112 participants

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Gender

ALL

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Sponsor

Ono Pharmaceutical Co. Ltd

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Birmingham

Alabama

Location available
View Birmingham location page
Unknown

Phoenix

Arizona

Location available
View Phoenix location page
Unknown

Duarte

California

Location available
View Duarte location page
Unknown

Irvine

California

Location available
View Irvine location page
Unknown

Palo Alto

California

Location available
View Palo Alto location page
Unknown

Aurora

Colorado

Location available
View Aurora location page
Unknown

New Haven

Connecticut

Location available
View New Haven location page
Unknown

Washington D.C.

District of Columbia

Location available
Unknown

Jacksonville

Florida

Location available
View Jacksonville location page

πŸ“ And 30 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

πŸ”’ Secure Β· πŸ₯ Expert Care

Looking for Primary Central Nervous System Lymphoma Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Primary Central Nervous System Lymphoma Treatment Options in Birmingham, Alabama

If you're searching for Primary Central Nervous System Lymphoma treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Phoenix, Duarte and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Primary Central Nervous System Lymphoma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 112 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Primary Central Nervous System Lymphoma?

Potential Benefits

  • βœ“Access to new treatment approaches before public availability
  • βœ“Close monitoring by experienced medical professionals
  • βœ“Study-related care provided at no cost
  • βœ“Contribute to medical research for Primary Central Nervous System Lymphoma

What to Expect

  • β†’Initial screening to determine eligibility
  • β†’Regular check-ups and monitoring visits
  • β†’Possible compensation for time and travel
  • β†’You can withdraw at any time

Frequently Asked Questions About This Primary Central Nervous System Lymphoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04947319. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.