Phase 1 Lymphoma Trial, Recruiting NCT06475235 Sponsor: Dana-Farber Cancer Institute Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT06475235
Recruiting Phase 1

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 newly diagnosed with a specific type of brain lymphoma called primary CNS diffuse large B-cell lymphoma (DLBCL), confirmed by a sample taken from the brain, spinal fluid, or fluid from the eye
  • People whose lymphoma is found only in the brain or central nervous system, with no signs of lymphoma elsewhere in the body (people with a past history of lymphoma limited to the eye that was treated only locally may still be considered eligible)
  • People who have not yet received chemotherapy or whole-brain radiation treatment for this condition
  • People aged 18 or older
  • People who are well enough to carry out basic daily activities (a doctor will assess this using a standard scale)
  • People whose blood counts, kidney function, liver function, and blood clotting results fall within acceptable ranges as assessed by a doctor
  • People who test negative for HIV
  • People with no history of organ transplantation and who are not currently taking medication to suppress their immune system
  • Women who could become pregnant must have a negative blood pregnancy test taken within 72 hours before joining the trial
  • Women who could become pregnant must agree to use a highly effective form of contraception throughout treatment and for 120 days after finishing the trial treatment
  • Male participants must agree to use contraception from their first dose until 120 days after the last dose, either by using a condom together with their partner using a highly effective contraceptive method, or by being in a long-term pattern of abstinence from penile-vaginal intercourse

Who may not be able to join:

  • People who are unable to have an MRI scan
  • People whose lymphoma is limited only to the eye, with no involvement of the brain or spinal cord
  • People currently taking part in another clinical trial involving an experimental treatment
  • People who have had a severe allergic reaction to medicines that are chemically similar to the study drugs
  • People who have previously been treated with certain immune checkpoint therapies (medicines that work on the PD-1, PD-L1, PD-L2, CTLA-4, OX-40, or CD137 pathways)
  • People who have an active autoimmune disease that requires ongoing treatment with immune-suppressing medicines or steroids
  • People who have received a live vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, or nasal flu spray) within 30 days before starting the trial (injected seasonal flu vaccines and COVID-19 vaccines are generally permitted)
  • People who have another cancer that is currently active or has required treatment within the past 3 years (some early-stage or successfully treated skin and in-situ cancers may not be excluded — confirm with trial site)
  • People with a history of lung inflammation (pneumonitis) that needed steroid treatment, or who currently have pneumonitis
  • People with poorly controlled diabetes, indicated by a blood sugar marker (HbA1c) above 8%
  • People who are unable to swallow capsules, or who have a condition that significantly affects how the gut absorbs food or medicine
  • People taking certain anti-seizure medications that affect how the body processes other drugs — these would need to be switched to a different type at least two weeks before starting the trial
  • People with a known history of active Hepatitis B or Hepatitis C infection
  • People with a known history of active tuberculosis (TB)
  • People with a known immune deficiency condition, or who are taking steroid medication at a dose higher than the equivalent of 10 mg of prednisone per day on an ongoing basis
  • People who have previously had an allogeneic stem cell transplant (a transplant using donor stem cells)
  • People with large fluid build-ups in the chest or abdomen, or widespread body swelling
  • People with known psychiatric conditions or substance use disorders that would make it difficult to follow the trial requirements
  • People who are pregnant, breastfeeding, or planning to conceive a child during the study period or within 120 days after the last dose of trial 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 27 July 2026
Phase 1: approximately ~10% 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: Lakshmi Nayak, MD, Dana-Farber Cancer Institute

Phone: 617-632-2166

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 1
Registry
ClinicalTrials.gov
Start date
18 October 2024
Est. completion
30 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Patients Experienced Dose Limiting Toxicity (DLT)

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: 27 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