🏛️ Verified NIH Record • Updated 2026-03-12

Odronextamab in Low Tumor Volume Advanced FL (NCT07128641)

A Phase II Study of Odronextamab in Treatment Naïve Patients With Low Tumor Volume Advanced Stage Follicular Lymphoma

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Gottfried von Keudell, MD PhD

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the safety and effectiveness of treating previously untreated Follicular Lymphoma (FL) with odronextamab. The name of the study drug in this research study is: -Odronextamab (a type of monoclonal antibody)

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (33 items) and avoid the listed exclusions (31 items).

Location: Beth Israel Deaconess Medical Center — Boston, Massachusetts

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participants must not meet any GELF Criteria for high tumor volume, or other circumstances for which immediate therapy would be indicated
  • Any nodal or extranodal tumor mass \>7 cm diameter
  • Involvement of at least 3 nodal sites, each with diameter \>3 cm
  • Presence of any systemic or B symptoms for greater than 2 weeks (fever, night sweats, or weight loss)
  • Splenic enlargement with inferior margin below the umbilical line
  • Compression syndrome (ureteral, orbital, gastrointestinal)
  • Pleural or peritoneal serous effusion (irrespective of cell content)
  • Leukemic phase (\>5.0 x10⁹/L circulating malignant cells)
  • Cytopenia (granulocyte count \< 1.0x10⁹/L and/or platelets \< 100x10⁹/L)
  • Infections:
  • Evidence of any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other) at study enrollment or within 2 weeks of study enrollment, if requiring ongoing treatment and/or has the potential to cause disseminated disease or severe infection upon immunosuppression. There should be evidence that the infection has cleared or is well controlled by start of study therapy.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Beth Israel Deaconess Medical Center — Boston, Massachusetts

📞 Contact the Study Coordinator

Phone: (617) 667-9920

Email: gkeudell@bidmc.harvard.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: Participants will receive the study drug for up to 6 cycles, or 126 days, and will be followed for up to 15 years.

More studies in Follicular Lymphoma

Explore by condition: All Follicular Lymphoma clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗