Follicular LymphomaPhase 2NCT04998669
Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
A Phase 2 study testing Loncastuximab tesirine and Rituximab in people with Follicular Lymphoma, run by Juan P. Alderuccio, MD at 5 sites in United States.
Trial summary
The purpose of this research is to see if Loncastuximab Tesirine in combination with Rituximab will result in higher complete response rate when given to treat follicular lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Lymphoma
- What is being tested?
- Loncastuximab tesirine and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Feb 2022to 1 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 18 years of age.
- 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.
- 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.
- 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.
- 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
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- 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
- Progression or relapse within 24 months of frontline treatment in patients previously treated with ≥1 line of systemic therapy; or
- Second FL relapse/progression after ≥1 line of systemic therapy. These patients will be eligible independently of GELF criteria and POD24.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy of greater than 6 weeks.
- 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).
Who cannot join
- FL grade 3B or transformed FL.
- [Removed]
- ≥ 6 lines of systemic immunochemotherapy for treatment of FL.
- Patients with clinically significant pleural effusions and/or ascites requiring drainage or associated with shortness of breath.
- Patients receiving any other investigational agents.
- Patients with known central nervous system involvement of lymphoma.
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- 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).
- Breastfeeding or pregnant women.
- 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.
- History of Human immunodeficiency virus (HIV) infection. Note: HIV screening test is optional
- Patients with impaired decision-making capacity.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Yasmin H Karimi, MD, 734-647-8902
Yasmin H Karimi, MD
- Not yet recruiting
Florida Cancer Specialists and Research Institute
Fort Myers, Florida, 33916
Chandni Patel, (561) 618-0383, Chandni.Patel@flcancer.com
Bradley J Monk, MD, FACS, (602) 300-0138, bradley.monk@flcancer.com
- Recruiting
University of Miami
Miami, Florida, 33136
Juan P Alderuccio, MD, 305-243-5995, jalderuccio@med.miami.edu
Juan P Alderuccio, MD
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Matt Matasar, MD, mm3511@cinj.rutgers.edu
Matt Matasar, MD
- Not yet recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Marla Harris, marla.harris@ahn.org
Maggie Saunders, maggie.saunders@ahn.org
About this study
Official title: Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
The purpose of this research is to see if Loncastuximab Tesirine in combination with Rituximab will result in higher complete response rate when given to treat follicular lymphoma.
- Conditions
- Follicular Lymphoma
- Being tested
- Loncastuximab tesirine, Rituximab
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loncastuximab tesirineDrug
Also called ADCT-402
Induction Phase (Cycles 1 through 4):
- 150 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 1 and 2.
- 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 3 and 4.
Maintenance Phase 1 (Cycle 5): For participants achieving CR or PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines). on Day 1 on Week 1, 4, 7 of a 8-week cycle.
Maintenance Phase 2 (Cycle 6 \& 7): For participants achieving PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Day 1 on Week 1, 4, 7 of a 8-week cycle.
RituximabDrug
Also called Rituxan
Induction Phase (Cycles 1 through 4): 375 mg/m2 rituximab on days 1, 8, 15 of cycle 1 and day 1 of cycle 2 via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase during Cycles 1 and 2, per discretion of treating physician. Rituximab will not be administered during Cycles 3 and 4.
Maintenance Phase 1 (Cycle 5): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 1 of a 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician.
Maintenance Phase 2 (Cycles 6 and 7): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 1 of each 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Loncastuximab tesirine + Rituximab | Experimental | During the 12-week Induction Phase (Cycles 1 to 4), participants will receive loncastuximab tesirine on days 1 of each 3-week cycle for Cycles 1 through 4; and rituximab on days 1, 8, 15 of Cycle 1 and day 1 of Cycle 2.
Maintenance Phase 1 (Cycle 5) is 8 weeks: Participants achieving complete response (CR) or partial response (PR) during the Induction Phase will receive loncastuximab tesirine once every 3-weeks; and rituximab once during week 7 or 8. Participants achieving a response of Stable Disease (SD) or Progressive Disease (PD) will be taken off treatment.
Maintenance Phase 2 (Cycles 6 and 7) is 16 weeks:
* Participants achieving CR during Maintenance Phase 1 receive rituximab once during week 7 or 8 of Cycles 6 and 7.
* Participants achieving PR during Maintenance Phase 1 receive loncastuximab tesirine once every 3-weeks over each 8 week cycle; and rituximab once during week 7 or 8 of Cycles 6 and 7.
* Participants achieving SD or PD will be taken off treatment. Receives: Drug: Loncastuximab tesirine; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants achieving Complete Response (CR)
Complete Response rate will be reported as the number of participants achieving complete response (CR) to study therapy. Response to therapy will be assessed using Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) (FDG-PET)/ Computerized Tomography (CT) following Lugano 2014 criteria by week 12 of treatment.
Measured: 12 weeks
Secondary outcomes (4)
Number of participants achieving CR or PR
Overall response rate (ORR) will be reported as the number of participants achieving complete response (CR) or partial response (PR) by the end of the induction phase, week 12. Response to therapy will be assessed using Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) (FDG-PET)/ Computerized Tomography (CT) following Lugano 2014 criteria.
Measured: Week 12
Incidence of Treatment-Related Adverse Events
Safety of the intervention will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion.
Measured: Up to 13 months
Progression-free Survival (PFS)
Progression-Free Survival (PFS) is defined as the elapsed time from the date of starting treatment (Cycle 1 Day 1) until disease progression or death (whichever occur first).
Measured: Up to 3 years
Overall Survival (OS)
Overall survival (OS) will be defined as the elapsed time from the date of starting treatment (Cycle 1 Day 1) until death.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start11 Feb 2022
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan P. Alderuccio, MD
- Sponsor type
- University, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Responsible party
- Sponsor-investigator, Juan P. Alderuccio, MD, University of Miami
- Investigators
- Juan P Alderuccio, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998669
- Sponsor's protocol ID
- 20201130
- Status last verified
- Mar 2026
- First submitted
- 7 Aug 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alderuccio JP, Alencar AJ, Schatz JH, Kuker RA, Pongas G, Reis IM, Lekakis LJ, Spiegel JY, Sandoval-Sus J, Beitinjaneh A, Stanchina MD, Trabolsi A, Lossos IS, Rosenblatt JD, Lessen DS, Moskowitz CH. Loncastuximab tesirine with rituximab in patients with relapsed or refractory follicular lymphoma: a single-centre, single-arm, phase 2 trial. Lancet Haematol. 2025 Jan;12(1):e23-e34. doi: 10.1016/S2352-3026(24)00345-4. Epub 2024 Dec 7.
PubMed 39662486
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Single-arm, Open-label, Study of Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma
- ClinicalTrials.gov ID
- NCT04998669
- Acronym / sponsor ID
- 20201130
- Conditions
- Follicular Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Juan P. Alderuccio, MDUniversity, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to see if Loncastuximab Tesirine in combination with Rituximab will result in higher complete response rate when given to treat follicular lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Loncastuximab tesirine + Rituximab | Experimental | Drug: Loncastuximab tesirine, Drug: RituximabDuring the 12-week Induction Phase (Cycles 1 to 4), participants will receive loncastuximab tesirine on days 1 of each 3-week cycle for Cycles 1 through 4; and rituximab on days 1, 8, 15 of Cycle 1 and day 1 of Cycle 2. Maintenance Phase 1 (Cycle 5) is 8 weeks: Participants achieving complete response (CR) or partial response (PR) during the Induction Phase will receive loncastuximab tesirine once every 3-weeks; and rituximab once during week 7 or 8. Participants achieving a response of Stable Disease (SD) or Progressive Disease (PD) will be taken off treatment. Maintenance Phase 2 (Cycles 6 and 7) is 16 weeks: * Participants achieving CR during Maintenance Phase 1 receive rituximab once during week 7 or 8 of Cycles 6 and 7. * Participants achieving PR during Maintenance Phase 1 receive loncastuximab tesirine once every 3-weeks over each 8 week cycle; and rituximab once during week 7 or 8 of Cycles 6 and 7. * Participants achieving SD or PD will be taken off treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Men and women ≥ 18 years of age.
- 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.
- 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.
- 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.
- Patient should have ≥ 1 Groupe d'Etude des Lymphomes (GELF) criteria for treatment initiation).
Key exclusion criteria (11 listed)
- FL grade 3B or transformed FL.
- [Removed]
- ≥ 6 lines of systemic immunochemotherapy for treatment of FL.
- Patients with clinically significant pleural effusions and/or ascites requiring drainage or associated with shortness of breath.
- Patients receiving any other investigational agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loncastuximab tesirineAlso: ADCT-402Induction Phase (Cycles 1 through 4): * 150 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 1 and 2. * 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 3 and 4. Maintenance Phase 1 (Cycle 5): For participants achieving CR or PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines). on Day 1 on Week 1, 4, 7 of a 8-week cycle. Maintenance Phase 2 (Cycle 6 \& 7): For participants achieving PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Day 1 on Week 1, 4, 7 of a 8-week cycle. | Drug | Loncastuximab tesirine + Rituximab |
| RituximabAlso: RituxanInduction Phase (Cycles 1 through 4): 375 mg/m2 rituximab on days 1, 8, 15 of cycle 1 and day 1 of cycle 2 via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase during Cycles 1 and 2, per discretion of treating physician. Rituximab will not be administered during Cycles 3 and 4. Maintenance Phase 1 (Cycle 5): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 1 of a 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician. Maintenance Phase 2 (Cycles 6 and 7): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 1 of each 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician. | Drug | Loncastuximab tesirine + Rituximab |
Primary outcome
Number of participants achieving Complete Response (CR)
Time frame: 12 weeks
Complete Response rate will be reported as the number of participants achieving complete response (CR) to study therapy. Response to therapy will be assessed using Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) (FDG-PET)/ Computerized Tomography (CT) following Lugano 2014 criteria by week 12 of treatment.
4 secondary outcomes
Number of participants achieving CR or PR
Time frame: Week 12
Incidence of Treatment-Related Adverse Events
Time frame: Up to 13 months
Progression-free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Derived from this study: PubMed 39662486Alderuccio JP, Alencar AJ, Schatz JH, Kuker RA, Pongas G, Reis IM, Lekakis LJ, Spiegel JY, Sandoval-Sus J, Beitinjaneh A, Stanchina MD, Trabolsi A, Lossos IS, Rosenblatt JD, Lessen DS, Moskowitz CH. Loncastuximab tesirine with rituximab in patients with relapsed or refractory follicular lymphoma: a single-centre, single-arm, phase 2 trial. Lancet Haematol. 2025 Jan;12(1):e23-e34. doi: 10.1016/S2352-3026(24)00345-4. Epub 2024 Dec 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juan P Alderuccio, MD principal investigator
University of Miami
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Loncastuximab tesirine and Rituximab in people with Follicular Lymphoma, run by Juan P. Alderuccio, MD at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan P Alderuccio, MD (305-243-5995, jalderuccio@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving Complete Response (CR) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04998669, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.