Phase 3 Lymphoma Trial, Recruiting NCT05929222 Sponsor: Fondazione Italiana Linfomi - ETS Condition: Lymphoma
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Phase 3 Lymphoma Trial, Recruiting

NCT05929222
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with Follicular Lymphoma grade 1 to 3A, confirmed by a tissue sample (biopsy)
  • Your lymphoma is at an early stage (Stage IA, IIA, or IE) and is not large (less than 7 cm), and fits within a single radiation treatment area
  • If you had a PET scan before surgery, you do not need to repeat it afterward to be eligible
  • You have not received any previous treatment for this lymphoma, except for steroids
  • Your lymphoma risk score (called FLIPI) falls within a low range (confirm with trial site)
  • You are 18 years of age or older
  • Your bone marrow biopsy shows no lymphoma involvement
  • You are willing to have blood and bone marrow samples tested for specific genetic markers related to this lymphoma
  • Your lymph node biopsy can be reviewed centrally and tested for a specific genetic change called t(14;18)
  • You are generally well enough to carry out daily activities (your performance score is 2 or below on a standard medical scale)
  • You have at least one affected lymph node measuring 2 cm or more before your biopsy
  • Your kidneys are working well enough (confirm specific level with trial site)
  • Your liver is functioning within acceptable levels (confirm specific levels with trial site)
  • You are willing and able to sign an informed consent form before the study begins
  • You are able to attend all required study visits and follow the study schedule
  • Your life expectancy is at least 3 months
  • Women must either be past menopause (no period for at least 12 months), have had surgery to prevent pregnancy, or be using a highly effective form of contraception throughout the study and for at least 18 months after treatment ends
  • Women who could become pregnant must have a negative pregnancy test before starting the study
  • Men with female partners who could become pregnant must use a condom plus an additional contraceptive method during treatment and for at least 3 months after the last dose, and must not donate sperm during this time
  • Men who have had a vasectomy must still agree to use effective barrier contraception or practise full abstinence during the study and for 3 months after the last dose

Who may not be able to join:

  • You have been diagnosed with Follicular Lymphoma grade 3B
  • Your lymphoma is at a more advanced stage (above Stage II), you have "B symptoms" (such as night sweats, fever, or unexplained weight loss), or your tumour is larger than 7 cm
  • You have Stage II lymphoma with affected areas that are too spread out to be covered by a single radiation field
  • Your lymphoma affects only the skin (primary cutaneous follicular lymphoma)
  • You are known to be HIV positive
  • You have active hepatitis C infection (a specific blood test will be used to confirm this)
  • You have active hepatitis B infection based on blood test results (some people with past exposure but no active infection may still be eligible — confirm with trial site)
  • Your lymphoma has spread to the brain or spinal cord
  • You have a serious history of neurological, psychiatric, hormonal, immune system, or liver disease that could affect your ability to participate safely
  • You have had another cancer within the past 3 years, unless it was certain early-stage or skin cancers that were fully treated and removed
  • You have an active, uncontrolled infection (viral, bacterial, or fungal) or require ongoing treatment for hepatitis B or C
  • You are currently pregnant or breastfeeding
  • You are already taking part in another clinical trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 5 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Alessandro Pulsoni, MD, Ospedale Santa Maria Goretti Latina

Phone: +390131033153

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Fondazione Italiana Linfomi - ETS
Registry
ClinicalTrials.gov
Start date
14 December 2023
Est. completion
1 April 2031

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Progression-free survival (PFS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 5 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov