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New drug combo shows promise for incurable blood cancer

NCT ID NCT06112847

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This study tests whether combining two drugs, epcoritamab and lenalidomide, can shrink or eliminate tumors in people with untreated follicular lymphoma, a slow-growing blood cancer that is not currently curable. About 29 adults with stage 1-3a disease who need treatment will receive the drug combination. The goal is to see how many patients achieve a complete response (no cancer detected) and to monitor side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

29 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed previously untreated FL grade 1-3a, requiring therapy per Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria * Radiologically measurable lymphadenopathy (\> 1.5 cm) or extranodal involvement (including spleen, bone marrow or other extranodal site) * Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000/mm\^3 With bone marrow involvement: ANC ≥ 500/mm\^3 * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement * Without bone marrow involvement: Platelets ≥ 50,000/mm\^3 With bone marrow involvement: Platelets ≥ 25,000/mm\^3 * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement. * Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless has Gilbert's disease) * Aspartate aminotransferase (AST) ≤ 2.5 x ULN * Alanine aminotransferase (ALT) ≤ 2.5 x ULN * Creatinine clearance of ≥ 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula or creatinine level \< 1.5 mg/dL * If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN * If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN * Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females and males of childbearing potential\* to use an effective method of birth control (i.e., failure rate of \< 1% per year) or abstain from heterosexual activity for the course of the study treatment period through at least 30 days after the last dose of lenalidomide, and 2 months after the last dose of epcoritamab, or 4 months after the last dose of tocilizumab (if applicable) whichever is longer * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from .menses for \> 1 year (women only) * All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)® program and be willing and able to comply with the requirements of the REMS program (including use of aspirin \[ASA\]/Food and Drug Administration \[FDA\] approved blood thinner) * Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program Exclusion Criteria: * Prior therapeutic intervention with any anti-cancer agents; localized radiotherapy ≤ 20 Gy total dose is permissible if occurred ≥ 4 weeks prior to first dose of study medication. * Participants must have at least one non-irradiated target lesion * Concurrent enrollment in another therapeutic investigational study * Vaccinated with live vaccines within 4 weeks of the first dose of study drug * Current evidence of central nervous system involvement by the lymphoma * Grade 3b or transformed FL * History of prior malignancy except: * Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy on current study * Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease * Asymptomatic prostate cancer managed with "watch and wait" strategy or hormonal therapy * Uncontrolled active systemic infection * Absolute lymphocyte count \> 5,000/uL * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with past HBV infection (defined as negative hepatitis B virus surface protein antigen \[HbsAg\] and positive hepatitis B core antibody \[HbcAb\]) are eligible if HBV deoxyribonucleic acid (DNA) is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). Testing to be done only in patients suspected of having infections or exposures * Known active human immunodeficiency virus (HIV) infection. Subjects who have an undetectable or unquantifiable HIV viral load with CD4 \> 200 and are on highly active antiretroviral therapy (HAART) medication are allowed. Testing to be done only in patients suspected of having infections or exposures * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months of screening * Females only: Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the final dose of all study drugs * Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study drug * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

  • City of Hope at Irvine Lennar

    Irvine, California, 92618, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.