EUCTR2021-000715-23-ITActive, not recruitingPhase 1
Consolidation with ADCT-402 (loncastuximab tesirine) after a short course of immunochemotherapy: a phase II study in BTKi-treated (or BTKi intolerant) Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) patients - FIL_COLUM
FONDAZIONE ITALIANA LINFOMI ONLUS0 sites56 target enrollmentStarted: October 4, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 56
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Histologically documented diagnosis of MCL as defined in the 2017 edition of the World Health Organization (WHO) classification;
- •2) Age >= 18 and < 80 years;
- •3) Relapsed/Refractory disease after one, two or three lines of treatment;
- •4) Bendamustine-naive or relapsed after at least two years after the last cycle of a bendamustine-containing regimen;
- •5) Previous treatment with BTKi monotherapy or BTKi containing regimens with R/R disease; and/or patients who discontinued BTKi monotherapy or BTKi containing regimens for adverse events and have active disease necessitating treatment;
- •6) Venetoclax treated patients are allowed;
- •7) Stem cell transplant eligible patients are allowed;
- •8) Measurable nodal or extranodal disease >= 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions.
- •9) ECOG/WHO performance status <= 2 (unless MCL-related);
- •10) Adequate liver, renal and bone marrow function, assessed by baseline laboratory values as indicated in the protocol;
- •11) 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;
- •12) Subject must be able to adhere to the study visit schedule and other protocol requirements;
- •13) Life expectancy >= 3 months;
- •14) 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 16 weeks after last loncastuximab tesirine (ADCT-402) dose.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
Exclusion Criteria
- •1) Subjects who have received a bendamustine containing regimen and relapsed less than two years after the end of treatment;
- •2) Known history of hypersensitivity to human antibodies;
- •3) Allogenic stem cell transplant within 6 months prior to start of first study drug;
- •4) Allogenic stem cell transplant with active / uncontrolled graft-versus-host disease;
- •5) Previous treatment with CD19 targeting agents;
- •6) More than three 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);
- •7) 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 the Sponsor and Coordinating Investigator agree and document should not be considered preclusive to participate in the study;
- •8) 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).
- •9) Cardiovascular disease (NYHA class =2);
- •10) 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;
- •11) Evidence of other clinically significant uncontrolled condition(s) as specified in protocol;
Investigators
Similar Trials
Recruiting
Phase 1
Consolidation with ADCT-402 (loncastuximab tesirine) after a short course of immunochemotherapy: a phase II study in BTKi-treated (or BTKi intolerant) Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) patientsMantle cell lymphomaCTIS2024-511633-35-00Fondazione Italiana Linfomi Ets49
Active, not recruiting
Phase 2
Consolidation With Loncastuximab Tesirine After a Short Course of Immunochemotherapy in BTKi-treated (or Intolerant) Relapsed/Refractory Mantle Cell Lymphoma Patients.Relapsed Mantle Cell LymphomaRefractory Mantle Cell LymphomaNCT05249959Fondazione Italiana Linfomi - ETS49
Active, not recruiting
Phase 3
Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell LymphomaRelapsed Diffuse Large B-Cell LymphomaRefractory Diffuse Large B-Cell LymphomaNCT04384484ADC Therapeutics S.A.440
Active, not recruiting
Phase 1
Testing Oral Decitabine and Cedazuridine (ASTX727) in Combination With Venetoclax for Higher-Risk Acute Myeloid Leukemia PatientsAcute Myeloid LeukemiaNCT04817241National Cancer Institute (NCI)5
Completed
Phase 2
A phase II trial of TAS-102 in combination with cetuximab for patients with RAS wild-type metastatic colorectal cancer refractory to previous anti-EGFR antibodies(WJOG8916G)Metastatic RAS wild type colorectal cancer which has become refractory or there was intolerance to chemotherapies (fluoropyrimidine, irinotecan, oxaliplatin) and bevacizumab, and refractory to anti-epidermal growth factor receptor(EGFR) antibodiesJPRN-UMIN000027210West Japan Oncology Group55