Marginal Zone LymphomaPhase 2NCT05296070
Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma
A Phase 2 study testing Loncastuximab tesirine 150 µg/Kg and Loncastuximab tesirine 75µg/Kg in people with Marginal Zone Lymphoma, run by University of Miami at 4 sites in United States.
Trial summary
The purpose of this research study is to see if loncastuximab tesirine has any benefits at dose levels researchers found acceptable in earlier studies in patients with related forms of immune cell cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marginal Zone Lymphoma
- What is being tested?
- Loncastuximab tesirine 150 µg/Kg and Loncastuximab tesirine 75µg/Kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Jun 2022to 30 Jun 2029
- 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, aged 18 years or older.
- Histologically confirmed MZL, including extranodal, nodal, and splenic subtypes.
- Previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody (cluster of differentiation antigen 20) (either as monotherapy or in combination as chemoimmunotherapy), with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen. Subjects with H. pylori-positive gastric extranodal MZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, subject has histologically confirmed MZL and was subsequently treated with at least 1 line of systemic therapy.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the LDi and ≥ 1.0 cm in the longest perpendicular diameter as assessed by CT or MRI per response criteria for lymphomas.68 Imaging must be conducted within 6 weeks prior to the start of therapy.
- Subjects with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that bone marrow infiltration of MZL is histologically confirmed.
- Subjects with skin EMZL (extranodal marginal zone lymphoma) who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that skin lesion measures ≥ 1.5 cm in diameter by tape measure and is documented by photo or there are multiple skin lesions measuring >1cm in diameter on the body that cannot be incorporated in one radiation field and at least one of them is histologically confirmed as MZL.
Show all 35Show fewer
- Subjects with gastric extranodal MZL histologically confirmed and need therapy but do not have measurable disease and in which response to treatment can be assess by multiple random gastric biopsies.
- Subjects with conjunctival EMZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided that conjunctival lesion measures ≥ 1 cm in diameter by tape measure and is documented by photo or there are multiple conjunctival lesions measuring together >1 5cm that cannot be treated by radiation because of previous radiation therapy, contraindications to radiation and patient refusal to receive radiation therapy. At least one of these lesions needs be histologically confirmed as MZL.
- Subjects must be willing to provide a lymph node or tissue biopsy from the most recent available archival tissue or undergo an incisional or excisional lymph node or tissue biopsy.
- Subjects with splenic MZL who do not have a tumor to biopsy or an archival tumor tissue sample are eligible for participation provided subject is willing to undergo a bone marrow biopsy or provide an archival bone marrow biopsy that was obtained before the date of the first dose of study treatment; bone marrow sample must show histologically confirmed infiltration of MZL.
- Patient should have at least one of the following 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 ≥5 cm
- B symptoms (fever ≥ 38 degrees Celsius of unclear etiology, night sweats, weight loss > 10% within the prior 6 months) or other symptoms attributed to disease or specific organ involvement associated with the relapse.
- Risk of local compressive symptoms that may result in organ compromise
- Splenomegaly or splenic lesion without splenomegaly
- Leukopenia attributed to MZL (leukocytes < 1000/mm3)
- Leukemia (> 5.000 lymphoma cells/mm3)
- Threatened organ function, especially for extranodal MZL
- Requirement for transfusion or growth factor support attributed to lymphoma
- Involvement of 2 or more extranodal sites, with tumor/lesion in each extranodal site ≥1 cm
- Progression or relapsed within 24 months after MZL diagnosis in patients previously treated with ≥1 line of systemic therapy
- Life expectancy > 3 months.
- ECOG (Eastern Cooperative Oncology Group ) performance status 0 to 2 (Refer to Appendix A).69
- Adequate hematologic, hepatic, and renal function tested within 6 weeks prior to the start of therapy (values must not be achieved with growth factors):
- ANC (absolute neutrophil count ) ≥ 1.0 × 109/L.
- Hemoglobin ≥ 8.0 g/dL.
- Platelet count ≥ 50 × 109/L.
- Total bilirubin ≤ 1.5 × ULN (upper limit of normal ). Subjects with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible.
- ALT(alanine aminotransferase) /AST (aspartate aminotransferase ) ≤ 3.0 ULN or ≤ 5 × ULN in the presence of liver involvement by lymphoma.
- Calculated creatinine clearance ≥ 45 mL/min by the Cockcroft-Gault Equation70 or the estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.
- Willingness to avoid pregnancy or fathering children based on the criteria below:
- Woman of nonchildbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 45 years of age).
- Woman of childbearing potential who has a negative serum pregnancy test at screening and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up at least 9 months after the last dose of loncastuximab tesirine. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed.
- Man, who agrees to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through at least 6 months after the last dose of study treatment. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the subject and their understanding confirmed.
Who cannot join
- Evidence of DLBCL transformation. a. Subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL.
- History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
- Active graft versus host disease.
- Receipt of anticancer medications or investigational drugs within the following intervals before the date of the first dose of study treatment:
Show all 24Show fewer
- < 10 weeks from completion of any radio- or toxin-immunoconjugates.
- < 4 weeks for immunotherapy
- <. 3 weeks for radiotherapy.
- < 2 weeks for any investigational agent or other anticancer medications.
- Steroids that are used for treatment of allergy or other underlying condition are permittable, but not steroids started to treat lymphoma. Subjects receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7 days of the study treatment administration.
- Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
- Prior treatment-related toxicities have not resolved to NCI CTCAE v5.071 ≤ Grade 1 before the date of the first dose of study treatment, except for stable chronic toxicities (≤ Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
- Previous treatment with anti CD19 (cluster of differentiation antigen 19 ) approaches
- Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy.
- Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease. Patients with pleural effusion, pericardial effusion or ascites should not be enrolled in this study, unless effusions are caused by lymphoma.
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment or exposure to a live vaccine within 30 days of dosing.
- Known HIV infection or positivity on immunoassay. Note: HIV screening test is optional
- Liver disease: HBV (hepatitis B virus) or HCV (hepatitis C virus) infection: Subjects positive for HBsAg or hepatitis B core antibody will be eligible if they are negative for HBV-DNA; these subjects should be considered for prophylactic antiviral therapy. Subjects positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA.
- Current New York Heart Association Class II to IV congestive heart failure or uncontrolled arrhythmia.
- 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)
- Currently pregnant or breastfeeding.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
- Patients with impaired decision-making capacity
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
Jean L Koff, MD, (404) 778-0519, jkoff@emory.edu
Jean L Koff, MD
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Johana Carmona, DO, PhD, 626.218.0942, gshouse@coh.org
Geoffrey Shouse, DO, PhD
- Recruiting
University of Miami
Miami, Florida, 33136
Lutecia Pereira, PhD, (305) 2436160, lpereira@med.miami.edu
Izidore Lossos, MD
- Recruiting
Vanderbilt University
Nashvile, Tennessee, 37232
Olalekan Oluwole, MD, 615-936-8422, olalekan.oluwole@vumc.org
Olalekan Oluwole, MD
About this study
Official title: A Phase 2, Open-label, Study Evaluating Safety and Efficacy of the Loncastuximab in Relapsed/Refractory Marginal Zone Lymphoma
The purpose of this research study is to see if loncastuximab tesirine has any benefits at dose levels researchers found acceptable in earlier studies in patients with related forms of immune cell cancers. The researchers want to find out the effects (good and bad) that loncastuximab tesirine has on the participant and the participant's condition.
- Conditions
- Marginal Zone Lymphoma
- Being tested
- Loncastuximab tesirine 150 µg/Kg, Loncastuximab tesirine 75µg/Kg
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loncastuximab tesirine 150 µg/KgDrug
Participants will be treated with loncastuximab tesirine at a dose of 150 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 1 - 2.
Loncastuximab tesirine 75µg/KgDrug
Participants will be treated with loncastuximab tesirine at a dose of 75 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 3 - 6.
| Study group | Role | What they receive |
|---|---|---|
| Loncastuximab tesirine Cycles 1-6 | Experimental | Patients will be treated with loncastuximab tesirine for a total of 6 cycles on Day 1 (+/-3) of each 21 day (3 week) cycle. The total duration of treatment is approximately 18 weeks (4.5 months) Receives: Drug: Loncastuximab tesirine 150 µg/Kg; Drug: Loncastuximab tesirine 75µg/Kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 6 months
CR rate is defined as the Complete Response (CR)/n, where n is the number of participants. The proportion of patients with best overall response of complete response (CR), per Cheson criteria if disease is not PET (Positron emission tomography)-avid in initial screening and by revised Lugano criteria if screening PET-CT demonstrated PET-avid disease.CR will be defined by a Deauville score of ≤ 3.
Measured: 6 months.
Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 12 months
CR rate is defined as the Complete Response (CR)/n, where n is the number of participants. The proportion of patients with best overall response of complete response (CR), per Cheson criteria if disease is not PET-avid in initial screening and by revised Lugano criteria if screening PET-CT demonstrated PET-avid disease.CR will be defined by a Deauville score of ≤ 3.
Measured: 12 months.
Secondary outcomes (8)
Partial Response rate at 6 months
PR rate Partial Response rate: (PR)/n, where n is the number of participants.The proportion of patients with best overall response of partial response (PR), per Cheson or revised Lugano criteria (based on PET avidity), among evaluable patients
Measured: 6 months
Partial Response rate at 12 months
PR rate Partial Response rate: (PR)/n, where n is the number of participants.The proportion of patients with best overall response of partial response (PR), per Cheson or revised Lugano criteria (based on PET avidity), among evaluable patients
Measured: 12 months
Overall response rate (ORR) at 6 months
Overall response rate (ORR): (CR+PR)/n, where n is the number of participants. The proportion of patients with best overall response of complete or partial responses, per Cheson or revised Lugano criteria (based on PET avidity) modified for MZL (marginal zone lymphoma), among evaluable patients
Measured: 6 months
Overall response rate (ORR) at 12 months
Overall response rate (ORR): (CR+PR)/n, where n is the number of participants. The proportion of patients with best overall response of complete or partial responses, per Cheson or revised Lugano criteria (based on PET avidity) modified for MZL, among evaluable patients.
Measured: 12 months
Progression-free survival (PFS)
Progression-free survival (PFS),which is defined as the elapsed time from start of treatment to documented progressive disease or death from any cause. For patients alive and progression-free, follow-up will be censored at the last date of document progression-free status.
Measured: 2 years
Overall survival (OS)
Overall survival (OS), defined as the elapsed time from start of treatment to death from any cause. Alive patients will censored at last date known to be alive.
Measured: 2 years
Duration of Response (DOR)
Duration of Response (DOR), defined as elapsed time from achievement of objective response (Complete Response or Partial Response) to progression, relapse, or death from any cause.
Measured: 2 years
Number of Treatment Related Toxicities
Defined as Adverse Events and Serious Adverse Events that are definitely, probably, or possibly related to treatment as assessed by treating physician.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start21 Jun 2022
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Responsible party
- Sponsor
- Investigators
- Izidore Lossos, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296070
- Sponsor's protocol ID
- 20211204
- Status last verified
- Sep 2026
- First submitted
- 15 Mar 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-label, Study Evaluating Safety and Efficacy of the Loncastuximab in Relapsed/Refractory Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT05296070
- Acronym / sponsor ID
- 20211204
- Conditions
- Marginal Zone Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 25 Mar 2022 (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 study is to see if loncastuximab tesirine has any benefits at dose levels researchers found acceptable in earlier studies in patients with related forms of immune cell cancers. The researchers want to find out the effects (good and bad) that loncastuximab tesirine has on the participant and the participant's condition.
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 Cycles 1-6 | Experimental | Drug: Loncastuximab tesirine 150 µg/Kg, Drug: Loncastuximab tesirine 75µg/KgPatients will be treated with loncastuximab tesirine for a total of 6 cycles on Day 1 (+/-3) of each 21 day (3 week) cycle. The total duration of treatment is approximately 18 weeks (4.5 months) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Men and women, aged 18 years or older.
- Histologically confirmed MZL, including extranodal, nodal, and splenic subtypes.
- Previously received 1 or more lines of systemic therapy, including at least 1 anti-CD20 antibody (cluster of differentiation antigen 20) (either as monotherapy or in combination as chemoimmunotherapy), with documented progression or documented failure to achieve CR or PR after the most recent systemic treatment regimen. Subjects with H. pylori-positive gastric extranodal MZL who received an initial treatment with currently accepted antibiotics may be considered eligible if, after antibiotic regimen, subject has histologically confirmed MZL and was subsequently treated with at least 1 line of systemic therapy.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the LDi and ≥ 1.0 cm in the longest perpendicular diameter as assessed by CT or MRI per response criteria for lymphomas.68 Imaging must be conducted within 6 weeks prior to the start of therapy.
- Subjects must be willing to provide a lymph node or tissue biopsy from the most recent available archival tissue or undergo an incisional or excisional lymph node or tissue biopsy.
Key exclusion criteria (24 listed)
- Evidence of DLBCL transformation. a. Subjects with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL.
- History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease.
- Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of the first dose of study treatment.
- Active graft versus host disease.
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 tesirine 150 µg/KgParticipants will be treated with loncastuximab tesirine at a dose of 150 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 1 - 2. | Drug | Loncastuximab tesirine Cycles 1-6 |
| Loncastuximab tesirine 75µg/KgParticipants will be treated with loncastuximab tesirine at a dose of 75 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 3 - 6. | Drug | Loncastuximab tesirine Cycles 1-6 |
Primary outcome
Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 6 months
Time frame: 6 months.
CR rate is defined as the Complete Response (CR)/n, where n is the number of participants. The proportion of patients with best overall response of complete response (CR), per Cheson criteria if disease is not PET (Positron emission tomography)-avid in initial screening and by revised Lugano criteria if screening PET-CT demonstrated PET-avid disease.CR will be defined by a Deauville score of ≤ 3.
Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 12 months
Time frame: 12 months.
CR rate is defined as the Complete Response (CR)/n, where n is the number of participants. The proportion of patients with best overall response of complete response (CR), per Cheson criteria if disease is not PET-avid in initial screening and by revised Lugano criteria if screening PET-CT demonstrated PET-avid disease.CR will be defined by a Deauville score of ≤ 3.
8 secondary outcomes
Partial Response rate at 6 months
Time frame: 6 months
Partial Response rate at 12 months
Time frame: 12 months
Overall response rate (ORR) at 6 months
Time frame: 6 months
Overall response rate (ORR) at 12 months
Time frame: 12 months
Progression-free survival (PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Duration of Response (DOR)
Time frame: 2 years
Number of Treatment Related Toxicities
Time frame: 7 months
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 21 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Marginal Zone Lymphoma
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 2
PET/CT-Guided Maintenance Therapy in Previously Untreated MZL
Marginal Zone Lymphoma(MZL)
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
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.
Izidore Lossos, MD principal investigator
University of Miami
4 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 150 µg/Kg and Loncastuximab tesirine 75µg/Kg in people with Marginal Zone Lymphoma, run by University of Miami at 4 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 35 inclusion and 24 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Philip Arlen, PhD (3052435247, paa107@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 6 months (time frame: 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.