Phase 2 Lymphoma Trial, Recruiting NCT06649812 Sponsor: National Cancer Institute (NCI) Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT06649812
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 aged 18 or older.
  • People who have been diagnosed with certain types of aggressive B-cell lymphoma confirmed by laboratory testing, falling into one of two groups: Group 1 includes several specific subtypes of a cancer called DLBCL or HGBCL that test negative for a protein called CD10; Group 2 includes a specific subtype of HGBCL that has certain genetic changes involving MYC and BCL2 genes (confirm with trial site for exact subtype details).
  • People whose lymphoma has come back or stopped responding to at least one previous treatment that included specific types of chemotherapy drugs (anthracyclines) and a targeted antibody therapy against CD20.
  • People whose blood counts and organ function meet certain minimum levels measured within 7 days before joining — including white blood cell counts, red blood cell levels, platelet counts, and liver and kidney function tests.
  • People living with HIV, as long as they are on effective HIV treatment and their viral load has been undetectable within the past 6 months.
  • People with a history of hepatitis B, as long as the virus is undetectable while on appropriate treatment.
  • People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
  • People with a history of lymphoma that had spread to the brain (secondary CNS lymphoma), as long as follow-up brain scans after treatment show no signs of the disease progressing.
  • People who have had or currently have another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial's safety or results.
  • People with heart disease history may be considered eligible if a doctor assesses their heart function and finds it meets a minimum standard (New York Heart Association Class 2B or better).
  • People who are able to provide a stored or new tumour tissue sample for laboratory analysis.
  • People who have measurable disease that can be tracked during the trial.
  • People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, even if with some limitations).
  • People who are able to understand and sign a consent form, or who have a legal representative or family member who can do so on their behalf.
  • People of childbearing potential must have a pregnancy test (with a specific sensitivity level) within 14 days before joining and again within 24 hours before starting treatment.

Who may not be able to join:

  • People who are pregnant, or who are of childbearing potential and are not willing to use effective contraception throughout the entire treatment period and for 6 months after the last dose.
  • People who are breastfeeding, or who are not willing to stop breastfeeding during treatment and for at least 6 months after the last dose.
  • Male participants who are not willing to use contraception during treatment and for 6 months after the last dose, or who are not willing to avoid donating semen or sperm during treatment and for at least 28 days after the last dose of one of the study drugs (lenalidomide).
  • People who are not willing to avoid donating blood during treatment and for at least 28 days after the last dose of lenalidomide.
  • People diagnosed with or suspected of having a specific type of lymphoma that starts in the middle of the chest (primary mediastinal large B-cell lymphoma).
  • People diagnosed with or suspected of having lymphoma that starts in the brain or spinal cord (primary CNS lymphoma).
  • People who have taken warfarin (a blood thinner) or certain other strong medications that affect how drugs are processed by the body, within 7 days before joining.
  • People who have an uncontrolled ongoing illness that could affect their safety or the trial results.
  • People who have an active infection at the time of joining.
  • People who have received chemotherapy, targeted therapy, antibody treatments, or similar anti-cancer therapies within 2 weeks before joining.
  • People who have received more than 3 prior rounds of cytotoxic (cell-killing) chemotherapy (with specific rules about how certain treatment combinations are counted — confirm with trial site).
  • People who have received a specific type of cancer treatment called a radio- or toxin-immunoconjugate within 10 weeks before joining.
  • People who have previously been treated with more than one of the following drugs: venetoclax (or a similar BCL2 inhibitor), ibrutinib (or a similar BTK inhibitor), or lenalidomide (or a similar drug in the same class).
  • People who have had a stem cell transplant (their own cells), CAR-T cell therapy, or an organ or donor stem cell transplant within 3 months before joining.
  • People who currently have graft-versus-host disease (a condition where donor cells attack the body) or who have needed immune-suppressing medications within 28 days before joining.
  • People who have not yet recovered from side effects of previous cancer treatments (with some exceptions, such as hair loss, at the treating doctor's discretion).

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 9 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.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
7 October 2025
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Complete response (CR) rate (CD10-negative diffuse large B cell lymphoma [DLBCL] and high grade B-cell lymphoma with MYC and BCL2 with or without BCL6 rearrangements [HGBCL-DH-BCL2])

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: 9 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