Phase 2 Lymphoma Trial, Recruiting NCT05615636 Sponsor: M.D. Anderson Cancer Center Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05615636
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 been diagnosed with relapsed CD20+ Follicular Lymphoma (grade 1–3a) — this applies to the safety run-in phase only
  • People who have been diagnosed with relapsed CD20+ diffuse large B-cell lymphoma — this applies to both phases of the trial
  • People whose lymphoma has come back or stopped responding after at least one previous treatment
  • People who are willing and able to give written consent and follow the study requirements
  • People aged 18 or older
  • People who have at least one area of measurable disease larger than 1.5 cm
  • People whose blood counts meet minimum levels required — including haemoglobin, neutrophil count, and platelet count (confirm with trial site)
  • People whose liver function test results are within acceptable ranges, with some allowances for a specific inherited condition called Gilbert's syndrome
  • People whose kidneys are functioning at an acceptable level, measured by a formula called Cockcroft-Gault (confirm with trial site)
  • People who are willing to receive blood product transfusions if needed
  • Men who are not surgically sterile must agree to use barrier contraception for at least 3 months after the last treatment dose, ask their partners to use additional contraception, and avoid donating sperm during this period
  • Women who are not surgically sterile and are of reproductive age must agree to use two forms of contraception for at least 12 months after the last treatment dose
  • Women of childbearing potential must have a negative pregnancy blood test within 10–14 days before, and again within 24 hours of, being prescribed lenalidomide, and must commit to ongoing pregnancy testing throughout the study
  • People who are able to take a daily low-dose aspirin as a blood-clot prevention measure (those who cannot tolerate aspirin may be able to use an alternative blood thinner)
  • People who are willing and able to enrol in and comply with the mandatory Revlimid REMS® programme

Who may not be able to join:

  • People with a known allergy to any of the study drugs
  • People who have previously been treated with polatuzumab vedotin
  • People who have previously been treated with mosunetuzumab or similar CD20-targeting bispecific antibody therapies
  • People who have previously been treated with tafasitamab and/or lenalidomide
  • People who had a stem cell transplant using their own cells within the 100 days before the first study treatment
  • People who received CAR-T cell therapy within 30 days before the first study treatment
  • People with relapsed/refractory diffuse large B-cell lymphoma who are currently considered eligible for their own stem cell transplant
  • People who have previously received a stem cell transplant using another person's cells
  • People who have had a solid organ transplant in the past
  • People with a history of severe allergic or anaphylactic reactions to monoclonal antibody therapies
  • People who have been regularly taking corticosteroid medicines in the two weeks before starting the trial (with some exceptions — confirm with trial site)
  • People who have received systemic chemotherapy, immunotherapy, or similar treatments within four weeks before starting the trial
  • People who received radiotherapy within two weeks before starting the trial (special conditions apply — confirm with trial site)
  • People who have had another cancer diagnosed within the last two years, with the exception of certain treated skin cancers or low-grade cervical changes
  • People with serious uncontrolled medical conditions such as uncontrolled high blood pressure, severe heart failure, uncontrolled heart rhythm problems, uncontrolled diabetes, active coronary artery disease, severe lung disease, poor heart pumping function, kidney failure, active infection, moderate-to-severe liver disease, active bleeding, or serious psychiatric illness (confirm with trial site)
  • People with a known or suspected history of a rare immune condition called haemophagocytic lymphohistiocytosis
  • People with a history of certain autoimmune diseases (some exceptions may apply — confirm with trial site)
  • People with a known active bacterial, viral, fungal, or other serious infection, or who required hospital treatment for infection within two weeks before starting the trial
  • People with suspected active or latent tuberculosis
  • People with known or suspected chronic active Epstein-Barr virus infection
  • People with known HIV infection
  • People with certain hepatitis B or hepatitis C results (specific testing requirements apply — confirm with trial site)
  • People who have received a live vaccine within 28 days before starting treatment
  • People with moderate-to-severe nerve damage (peripheral neuropathy of grade 2 or higher, or grade 2 with pain)
  • Women who are pregnant or breastfeeding
  • People with known lymphoma involvement in the brain or central nervous system
  • People who cannot tolerate certain required supporting medications or fluid treatments due to pre-existing heart or lung conditions
  • People with an active blood clot in the lungs or a deep vein clot diagnosed within 30 days of enrolling
  • People who have had major surgery within four weeks of starting the trial, or who have an unhealed wound
  • People who have had a stroke or bleeding in the brain within six months before starting the trial
  • People with active bleeding or a known bleeding disorder such as haemophilia or von Willebrand disease
  • People with uncontrolled autoimmune destruction of red blood cells or platelets
  • People whose blood clotting test results are above an acceptable level (confirm with trial site)
  • People who are currently participating in another therapeutic clinical trial

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 21 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: Jason Westin, MD, MS, FACP, M.D. Anderson Cancer Center

Phone: 713-792-3750

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
Registry
ClinicalTrials.gov
Start date
28 April 2023
Est. completion
19 August 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The best overall response rate (ORR).

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: 21 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