Phase 2 Lymphoma Trial, Recruiting NCT05351593 Sponsor: James Rubenstein Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05351593
Recruiting Phase 2

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 a type of lymphoma called diffuse large B-cell lymphoma (DLBCL) that has come back and is affecting the brain, spinal fluid, or eyes, confirmed by imaging, eye examination, or spinal fluid testing.
  • People whose lymphoma also exists outside the brain and nervous system, or whose lymphoma developed from a different type (follicular lymphoma or chronic lymphocytic leukaemia), may also be considered.
  • Adults aged 18 years or older.
  • People whose doctor estimates they are expected to live for more than 2 months.
  • People who are reasonably active and able to care for themselves (confirm with trial site what this means for your specific situation).
  • People whose blood cell counts, liver function, and kidney function meet specific minimum levels set by the trial (confirm with trial site).
  • People who are able to understand and sign a consent form agreeing to take part.
  • People with a history of hepatitis B who have an undetectable level of virus while on treatment, if treatment is required.
  • People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable level of the virus.
  • People who have had or currently have another type of cancer, as long as that cancer or its treatment is not likely to interfere with this trial's results or safety (confirm with trial site).
  • People who are able and willing to use effective contraception during the trial, as the effects of the study drugs on an unborn baby are not yet known — this applies to women who could become pregnant and to men.
  • People who have already received at least one prior treatment for their lymphoma affecting the brain, and, if the lymphoma spread to the brain from elsewhere, at least one prior treatment directed at the brain or nervous system.
  • People who have previously received other treatments, including stem cell transplants, rituximab, or similar drugs, may still be considered — there is no limit on the number of prior treatments.
  • People who have had a stem cell transplant, as long as they no longer have graft-versus-host disease and are no longer taking immunosuppressant medications.

Who may not be able to join:

  • People who have received anti-cancer treatment within the past 2 weeks, radiation within the past 1 week, or antibody-based therapy within the past 4 weeks before the trial starts.
  • People who are still experiencing significant side effects from a previous cancer treatment that have not resolved to a mild or baseline level (hair loss is an exception).
  • People who are currently taking part in another clinical trial or using an experimental treatment or device.
  • People who have taken part in a study involving an experimental treatment or device within the past 4 weeks.
  • People with a history of HIV infection.
  • People whose lymphoma in the brain or nervous system developed as a complication after an organ or stem cell transplant (a condition called post-transplant lymphoproliferative disease).
  • People who have a known allergic reaction to either of the study drugs (lenalidomide or tafasitamab).
  • People who are pregnant, breastfeeding, or who are able to become pregnant but are unwilling to use effective contraception during the trial.
  • People who have previously received a treatment that targets a protein called CD19 on cancer cells, including a type of treatment called CAR-T cell therapy.
  • People who have a serious medical condition or infection that is not under control and could put their safety at risk.

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 26 July 2026
Phase 2: approximately ~30% 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: 877-827-3222

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 2
Sponsor
James Rubenstein
Registry
ClinicalTrials.gov
Start date
8 June 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Proportion of participants with dose limiting toxicities (DLTs) (Phase 1); Maximum Tolerated Dose (MTD) (Phase 1); Recommended Phase 2 Dose (RP2D) (Phase1); Percentage of participants with demonstrated Clinical Benefit Rate (CBR) (Phase 2)

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: 26 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