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New treatment option for Marginal Zone Lymphoma
Official title Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma
ClinicalTrials.gov ID: NCT05296070
What this study is testing
What is Loncastuximab tesirine 150 µg/Kg?
Loncastuximab tesirine 150 µg/Kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for marginal zone lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures \> 1.5 cm in the...
- people with splenic MZL who do not meet the radiographically measurable disease criteria described herein are eligible for participation provided...
You likely can't join if
- Evidence of DLBCL transformation. a. people with presumptive evidence of transformation based on clinical assessment of factors such as, but not...
- 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...
- 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...
- 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:
See the full eligibility criteria
Who can 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...
- 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...
- people 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.
- people 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...
- people 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.
- people 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...
- people 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. a. people with splenic MZL who do not...
- 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 ). people 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...
- 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...
What rules you out
- Evidence of DLBCL transformation. a. people with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease...
- 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:
- \< 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. people receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7...
- 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...
- 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...
- Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease. Patients with pleural...
- 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: people positive for HBsAg or hepatitis B core antibody will be eligible if they are negative for HBV-DNA; these people should be considered...
- 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...
- Patients with impaired decision-making capacity
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.