Phase 3 study for people with Lymphoma

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 14 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Regeneron Pharmaceuticals
Registry number NCT06149286
Started 28 December 2023 Today 16 October 2026 Estimated completion 30 April 2031

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Liverpool Hospital Liverpool NSW Recruiting
Calvary Mater Newcastle Waratah NSW Recruiting
Pindara Private Hospital Benowa QLD Recruiting
Royal Hobart Hospital Hobart TAS Recruiting
Epworth Freemasons East Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 14 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 580

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Key Inclusion Criteria:

1. Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator, as described in the protocol.

2. Must have refractory disease or relapsed after at least 1 prior line (with a duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-Cluster of Differentiation 20 (CD20) monoclonal antibody, and participant should meet indication for treatment, as described in the protocol.

3. Have measurable disease on cross sectional imaging documented by diagnostic Computed Tomography \[CT\], or Magnetic Resonance Imaging \[MRI\] imaging, as described in the protocol.

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

5. Adequate hematologic and organ function, as described in the protocol.

6. All study participants must:

1. Have an understanding that lenalidomide could have a potential teratogenic risk.

2. Agree to abstain from donating blood while taking study drug therapy and for 28 days after discontinuation of lenalidomide.

3. Agree not to share study medication with another person.

4. Agree to be counseled about pregnancy precautions and risk of fetal exposure associated with lenalidomide.

Key Exclusion Criteria:

1. Primary Central Nervous System (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL, as described in the protocol.

2. Participants with current or past histological evidence of high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.

3. History of or current relevant CNS pathology, as described in the protocol.

4. A malignancy other than NHL (inclusion diagnosis) unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.

5. Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.

6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol.

7. Active infection as defined in the protocol.

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Dates on the record

Started 28 December 2023
Estimated completion 30 April 2031
Registry last updated 7 October 2026
Checked by Voxsanity 14 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 7 October 2026.
  • This page last checked by Voxsanity: 14 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.