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NCT05888493RECRUITINGIRB Ready

A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

(LEDA)

Sponsored by Novartis Pharmaceuticals

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
📊
1 of 108 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 trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.

Who Can Participate

Inclusion Criteria

Age ≥ 18 years at the date of signing the informed consent form. 2. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment). 3. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent. 4. Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan. 5. ECOG performance status of 0, 1 or 2 at screening. 6. Adequate hematologic, renal, hepatic and pulmonary organ function at screening. 7. Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available). 8. Must be eligible for treatment with the selected standard of care regimen.

Exclusion Criteria

Follicular lymphoma grade 3B or evidence of histologic transformation. 2. Prior treatment with anti-CD19 therapy, gene therapy

❓ 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

108 participants

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Age Range

18 Years - 100 Years

Gender

ALL

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Sponsor

Novartis Pharmaceuticals

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Cincinnati

Ohio

Location available
RECRUITING

Nashville

Tennessee

Location 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

🔒 Secure · 🏥 Expert Care

Looking for Follicular Lymphoma Treatment in Cincinnati?

Join others in Ohio exploring innovative treatment options through clinical research

Follicular Lymphoma Treatment Options in Cincinnati, Ohio

If you're searching for Follicular Lymphoma treatment in Cincinnati, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Cincinnati, Nashville, Camperdown 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 Follicular Lymphoma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Ohio
Now Enrolling
Up to 108 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Follicular Lymphoma?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Follicular Lymphoma

What to Expect

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

Frequently Asked Questions About This Follicular 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: NCT05888493. 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.