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Promising drug combo targets Tough-to-Treat lymphoma

NCT ID NCT04998669

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial is testing whether a combination of two drugs—loncastuximab tesirine and rituximab—can shrink or eliminate tumors in people with follicular lymphoma that has come back or not responded to previous treatment. About 100 adults will receive the drugs through an IV over several cycles. The main goal is to see how many patients achieve a complete response (no signs of cancer) by week 12.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
loncastuximab tesirine (a drug that targets and kills cancer cells) combined with rituximab (an antibody therapy)
What this could lead to
If successful, this combination could offer a new treatment option for people with follicular lymphoma that has come back or not responded to prior therapy.
What could go wrong
This is a Phase 2 trial with only 100 participants, so results are preliminary. The drug combination may cause side effects and might not work for everyone.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Aug 2030

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: 1. Men and women ≥ 18 years of age. 2. Patients must have histologic confirmation of Follicular Lymphoma (FL) (grade 1, 2 and 3A). Note: Participants who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy. 3. Patients with relapsed or refractory FL previously treated with ≥1 line of systemic therapy having ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria for therapy, or Progression of Diseases within 24 months (POD24), or second relapse. 4. Baseline FDG-PET/CT scans must demonstrate positive lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification. 5. Patient should have ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria for treatment initiation). * Involvement of ≥3 nodal sites, each with diameter of ≥3 cm * Any nodal or extranodal tumor mass with a diameter of ≥7 cm * B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss \> 10% within the prior 6 months). * Risk of local compressive symptoms that may result in organ compromise * Splenomegaly or splenic lesion without splenomegaly * Leukopenia (leukocytes \< 1000/mm3) * Leukemia (\> 5.000 lymphoma cells/mm3) * Bone lesions detected on FDG-PET/CT; or 6. Progression or relapse within 24 months of frontline treatment in patients previously treated with ≥1 line of systemic therapy; or 7. Second FL relapse/progression after ≥1 line of systemic therapy. These patients will be eligible independently of GELF criteria and POD24. 8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 9. Life expectancy of greater than 6 weeks. 10. Patients must have normal organ and marrow function as defined below, * Absolute neutrophil count ≥1000/mm3 (unless due to lymphoma involvement of the bone marrow or spleen). * Platelets ≥100,000/mm3 or ≥ 60,000/mm3 in case of bone marrow involvement by lymphoma. * Hemoglobin ≥ 10 g/dL or ≥8 g/dL in case of bone marrow involvement by lymphoma. * Total bilirubin \< 1.5 x within normal institutional limits (unless due to lymphoma involvement of liver or a known history of Gilbert's disease). * Gamma-Glutamyl Transpeptidase (GGT)/Aspartate Aminotransferase (AST)/(SGOT)/Alanine Aminotransferase (ALT)(SGPT) ≤ 2.5 × institutional upper limit of normal. * Creatinine within normal institutional limits, or creatinine clearance ≥30 ml/min/1.7m\^2 for patients with creatinine levels above institutional normal (unless due to lymphoma). Exclusion Criteria: 1. FL grade 3B or transformed FL. 2. \[Removed\] 3. ≥ 6 lines of systemic immunochemotherapy for treatment of FL. 4. Patients with clinically significant pleural effusions and/or ascites requiring drainage or associated with shortness of breath. 5. Patients receiving any other investigational agents. 6. Patients with known central nervous system involvement of lymphoma. 7. Uncontrolled intercurrent illness such as: history of Myocardial Infarction (MI) in the last 6 months, congestive heart failure New York Heart Association (NYHA) Class III-IV, uncontrolled or symptomatic arrhythmia, stroke in last 6 months, liver cirrhosis, and autoimmune disorder requiring immunosuppression or long-term corticosteroids (\>10 mg daily prednisone equivalent). 8. Breastfeeding or pregnant women. 9. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody will need a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.) Hepatitis C antibody positive patients are eligible if PCR is negative. Hepatitis B core antibody (+) patients without evidence of HBsAg or Hep B PCR (+) are eligible with appropriate Hepatitis B reactivation prophylaxis. 10. History of Human immunodeficiency virus (HIV) infection. Note: HIV screening test is optional 11. Patients with impaired decision-making capacity.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny Health Network

    NOT_YET_RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Florida Cancer Specialists and Research Institute

    NOT_YET_RECRUITING

    Fort Myers, Florida, 33916, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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