Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma
ConditionMarginal Zone Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Loncastuximab tesirine 150 µg/Kg
DrugParticipants 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/Kg
DrugParticipants 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Loncastuximab tesirine Cycles 1-6Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
6 months.2
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.
Time frame
12 months.Secondary outcomes
1
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
Time frame
6 months2
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
Time frame
12 months3
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
Time frame
6 months4
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.
Time frame
12 monthsSponsors and contacts
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University of Miami
Lead sponsor
ADC Therapeutics S.A.
Collaborator
Source ClinicalTrials.gov