Phase 3 Lymphoma Trial, Recruiting NCT04442412 Sponsor: Fondazione Italiana Linfomi - ETS Condition: Lymphoma
Back to Lymphoma

Phase 3 Lymphoma Trial, Recruiting

NCT04442412
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:

  • People who have been confirmed by a tissue biopsy to have Diffuse Large B-cell Lymphoma (DLBCL) or Follicular grade IIIb lymphoma, as classified by the 2017 World Health Organization guidelines.
  • People aged 65 or older.
  • People who have had a full geriatric (older adult health) assessment completed before any treatment begins.
  • People whose general health and ability to carry out daily activities falls within a certain range on a standard medical scale (confirm with trial site).
  • People whose doctors have determined them suitable to receive a standard chemotherapy treatment plan that includes a drug type called an anthracycline (either R-CHOP or R-miniCHOP).
  • People who have never previously received treatment for DLBCL or Follicular grade IIIb lymphoma.
  • People whose lymphoma is classified at any stage from Stage I to Stage IV.
  • People who have at least one area of lymphoma that is large enough to be measured on a scan — either a mass of at least 1.5 cm on a CT scan, or a metabolically active area visible on a PET scan.
  • People whose blood level of Vitamin D is 40 ng/ml or below.
  • People whose blood counts (white blood cells, platelets) meet minimum levels set by the trial, unless low counts are caused by the lymphoma itself.
  • People whose kidney function meets the trial's minimum requirement, unless any reduction is caused by the lymphoma.
  • People whose liver function meets the trial's minimum requirement, unless any reduction is caused by the lymphoma.
  • People whose heart pumping function is above 50%, as measured by an echocardiogram (heart ultrasound).
  • People who are expected to live at least 6 months.
  • People who are willing and able to sign a consent form after being informed about the trial, before any study procedures begin.
  • People who are able to attend all required trial visits and follow the study schedule.
  • Men who agree to use an acceptable form of contraception throughout the study and for 3 months after the last dose of treatment, and who agree not to donate sperm during this time.

Who may not be able to join:

  • People whose lymphoma is a different type than DLBCL or Follicular grade IIIb lymphoma, including a high-grade form known as "double-hit" lymphoma (involving specific gene changes called MYC, BCL2, and/or BCL6).
  • People who are already taking Vitamin D supplements at a dose higher than 10,000 units per week as part of their standard care.
  • People who have suspected or confirmed spread of lymphoma to the brain or spinal cord.
  • People who have a medical reason that prevents them from receiving the drug rituximab.
  • People who have a medical reason that prevents them from taking Vitamin D supplements — for example, having too much calcium or phosphate in their blood.
  • People who have received any cancer treatment (such as chemotherapy, immunotherapy, radiation, or experimental treatments) within 14 days before the first study dose.
  • People with a significant history of serious neurological, psychiatric, hormonal, metabolic, immune, or liver conditions that could interfere with participation or with giving informed consent.
  • People who have had another active cancer within the past 2 years — although certain early-stage or fully treated cancers may be exceptions (confirm with trial site).
  • People with other serious uncontrolled medical conditions, including active or uncontrolled infections (viral, bacterial, or fungal), or chronic Hepatitis B or Hepatitis C that requires treatment.

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 20 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: Francesco Merli, Dott., Reggio Emilia - Azienda Unitа Sanitaria Locale-IRCCS

Phone: 0000000000

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
23 March 2021
Est. completion
1 September 2025

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Progression-Free Survival

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: 20 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