Promising drug combo targets Tough-to-Treat lymphoma
NCT ID NCT04998669
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Allegheny Health Network
NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15212, United States
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Florida Cancer Specialists and Research Institute
NOT_YET_RECRUITINGFort Myers, Florida, 33916, United States
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Rutgers Cancer Institute of New Jersey
RECRUITINGNew Brunswick, New Jersey, 08901, United States
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- New antibody tested against aggressive blood cancer
- Can a new drug delay the need for lymphoma treatment?
- Can a single injection reprogram immune cells to fight cancer?
- Can a new immune cell therapy outsmart resistant blood cancers?
- Can a Triple-Drug combo wipe out Slow-Growing lymphomas?