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New treatment option for Relapsed Mantle Cell Lymphoma
Official title Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.
ClinicalTrials.gov ID: NCT05249959
What this study is testing
What is Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C))?
Consolidation with ADCT-402 (loncastuximab tesirine) after salvage immunochemotherapy at standard dose (R-BAC, Rituximab - Bendamustine, Ara-C)) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed mantle cell 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
- This is a prospective, phase 2, multicenter, open-label, single-arm study. Primary objective is to assess the efficacy of loncastuximab tesirine given as consolidation therapy after salvage immunochemotherapy in BTKi (Bruton Tyrosine Kinase inhibitors) -treated (or BTKi intolerant) R/R (Relapse or Refractory) MCL (Mantle Cell Lymphoma) patients.
- 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 to 79
You may be able to join if
- Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification
- Age ≥ 18 and \< 85 years
- Relapsed/Refractory disease after one, two, three or four lines of treatment
- Bendamustine-naive or relapsed after at least one year after the last cycle of a bendamustine-containing regimen
- Previous treatment with BTKi (Bruton Tyrosine Kinase inhibitors) monotherapy or BTKi containing regimens with R/R disease; and/or patients who...
You likely can't join if
- people who have received a bendamustine containing regimen and relapsed less than one year after the end of treatment.
- Known history of hypersensitivity to human antibodies.
- Allogenic stem cell transplant within 6 months prior to start of first study drug.
- Allogenic stem cell transplant with active / uncontrolled graft-versus-host disease.
- Previous treatment with CD19 targeting agents.
- More than four lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should...
See the full eligibility criteria
- Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification
- Age ≥ 18 and \< 85 years
- Relapsed/Refractory disease after one, two, three or four lines of treatment
- Bendamustine-naive or relapsed after at least one year after the last cycle of a bendamustine-containing regimen
- Previous treatment with BTKi (Bruton Tyrosine Kinase inhibitors) monotherapy or BTKi containing regimens with R/R disease; and/or patients who discontinued BTKi monotherapy or BTKi containing regimens for adverse events...
- Previous treatment with any anti-CD19 agents is allowed (included CAR-T treatment) If previous anti-CD19 treatment has occurred, tissue CD19 expression must be assessed by histology or flow cytometry
- Venetoclax treated patients are allowed.
- Stem cell transplant eligible patients are allowed.
- Measurable nodal or extranodal disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions. Note: Patients with bone marrow involvement only are eligible. In case of bone marrow infiltration only...
- ECOG (Eastern Cooperative Oncology Group)/WHO (World Health Organization) performance status ≤ 2 (unless MCL-related)
- The following laboratory values at screening (unless due to bone marrow involvement by lymphoma):
- Absolute Neutrophil count (ANC) \> 1.0×109/L
- Platelet count ≥ 75.000/mm3
- Creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN (upper limit of normal)
- Bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non- hepatic origin)
- Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures.
- Subject must be able to adhere to the study visit schedule and other protocol requirements.
- Life expectancy ≥ 3 months.
- Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active.This applies for the time period between signing of the informed consent form and at least 10 months after...
- people who have received a bendamustine containing regimen and relapsed less than one year after the end of treatment.
- Known history of hypersensitivity to human antibodies.
- Allogenic stem cell transplant within 6 months prior to start of first study drug.
- Allogenic stem cell transplant with active / uncontrolled graft-versus-host disease.
- Previous treatment with CD19 targeting agents.
- More than four lines of previous treatment (autologous stem cell transplant performed as part of consolidation to a previous line of therapy should not be considered as a line of therapy).
- Active second malignancy in the last three years other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or any other tumor that...
- Major surgery or any anticancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to start of study drug (R-BAC). A...
- Cardiovascular disease (NYHA, New York Heart Association, class ≥2).
- Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.
- Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
- Uncontrolled and/or active systemic infection (viral including COVID 19, bacterial or fungal);
- Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: people with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb...
- HIV seropositivity.
- Lymphoma with active CNS (central nervous system) involvement at the time of screening, including leptomeningeal disease.
- Congenital long QT syndrome or a corrected QTcF interval of \>480 msec at screening (unless secondary to pacemaker or bundle branch block).
- Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk.
- If female, the patient is pregnant or breast-feeding.
The study team makes the final eligibility decision.
Where it's taking place
- Brescia, Italy, Italy
- Alessandria, Italy
- Cuneo, Italy
- Florence, Italy
- Genova, Italy
- Milan, Italy
- Naples, Italy
- Novara, Italy
- Palermo, Italy
- Pavia, Italy
- Ravenna, Italy
- Reggio Emilia, Italy
- Rimini, Italy
- Roma, Italy
- Rozzano, Italy
- Torino, Italy
- Treviso, Italy
- Tricase, Italy
- Trieste, Italy
- Verona, Italy
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 to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brescia, Italy, Italy; Alessandria, Italy; Cuneo, Italy; Florence, Italy; Genova, Italy; Milan, Italy and 14 more location(s). 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.