Phase 1 Lymphoma Trial, Recruiting NCT04656431 Sponsor: James Rubenstein Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT04656431
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 are over 18 years old and expected to live for more than 12 weeks.
  • People who have been diagnosed with a specific type of brain/central nervous system lymphoma called DLBCL-type (confirmed by a tissue biopsy).
  • People in Group 1: Those whose CNS lymphoma has come back after previous treatment, with visible disease on a brain scan.
  • People in Group 2: Those who have been newly diagnosed with primary CNS lymphoma and are planned to receive a standard combination of chemotherapy drugs (high-dose methotrexate, temozolomide, and rituximab).
  • People who have a brain scan taken within two weeks of joining that shows an active lymphoma lesion of at least one centimetre in size, using a special contrast dye (gadolinium).
  • People whose lymphoma has also spread to the fluid around the brain/spine or the eyes — this is still permitted.
  • People whose kidneys are working well enough (confirmed by a blood test done within 21 days before the imaging scan).
  • People who are eligible, in their doctor's opinion, to receive high-dose methotrexate chemotherapy.
  • People of any gender or racial/ethnic background — the trial actively recruits minorities, and no one is excluded based on race.
  • People who sign the required consent forms agreeing to take part and to allow their health information to be used for the study.

Who may not be able to join:

  • People who have significant medical conditions that, in the opinion of the treating doctor, cannot be well managed or that could interfere with the imaging or treatment results.
  • People with moderate or severe heart failure (classified as New York Heart Association Grade II or higher).
  • People who have had another cancer in the past, unless it was a minor skin cancer or a cervical pre-cancer, or unless they have been in full remission and off all cancer treatment for more than three years.
  • People who are pregnant or breastfeeding. A negative pregnancy test within 14 days of the imaging scan is required for people who could become pregnant. Effective contraception must be used by participants who could father or carry a child.
  • People who are not able to follow the study procedures and required follow-up visits.

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 14 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: James Rubenstein, MD, PhD, University of California, San Francisco

Phone: (415) 514-4418

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
Sponsor
James Rubenstein
Registry
ClinicalTrials.gov
Start date
29 June 2021
Est. completion
31 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of participants with treatment-emergent Adverse Events; Number of participants with abnormal changes in vital signs; Number of participants with abnormal changes in injection site; Percent of eligible patients that complete the study; Pyruvate-to lactate conversion (kPL); Number of participants with response; Signal Amplitudes; Time Dynamics

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: 14 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