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

Who is this study for? Patients with Lymphoma
What treatments are being studied? Consolidation with ADCT-402 (Loncastuximab Tesirine) After Salvage Immunochemotherapy (R-BAC, Rituximab - Bendamustine, Ara-C))
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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. The sponsor of this clinical trial is Fondazione Italiana Linfomi - ETS (FIL ETS).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
View:

• 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 and have active disease necessitating treatment.

• 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, bone marrow aspiration and biopsy are mandatory for all staging evaluations

• 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 last loncastuximab tesirine (ADCT-402) dose. Men with female partners who are of childbearing potential 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 7 months after last loncastuximab tesirine (ADCT-402) dose.

Locations
Other Locations
Italy
S.C. Ematologia - A.S.O. SS Antonio e Biagio e Cesare Arrigo
RECRUITING
Alessandria
ASST Spedali Civili di Brescia
RECRUITING
Brescia
S.C. di Ematologia - A.O. S. Croce e Carle
RECRUITING
Cuneo
Unità funzionale di Ematologia - Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
Ematologia - Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia
RECRUITING
Genova
Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
RECRUITING
Milan
S.C. Ematologia - ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
UOC Ematologia Oncologica - Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale
RECRUITING
Napoli
SCDU Ematologia - AOU Maggiore della Carità di Novara
RECRUITING
Novara
Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
RECRUITING
Palermo
Divisione di Ematologia - IRCCS Policlinico S. Matteo di Pavia
RECRUITING
Pavia
Ematologia - Ospedale delle Croci
RECRUITING
Ravenna
Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
RECRUITING
Reggio Emilia
U.O. di Ematologia - Ospedale degli Infermi di Rimini
RECRUITING
Rimini
Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università La Sapienza Istituto Ematologia
RECRUITING
Roma
U.O. Ematologia - Istituto Clinico Humanitas
RECRUITING
Rozzano
S.C. Ematologia Universitaria - A.O.U. Città della Salute e della Scienza di Torino
RECRUITING
Torino
S.C di Ematologia - Ospedale Ca Foncello
RECRUITING
Treviso
U.O.C Ematologia e Trapianto - A.O. C. Panico
RECRUITING
Tricase
SC Ematologia - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI)
RECRUITING
Trieste
U.O. Ematologia - AOU Integrata di Verona
RECRUITING
Verona
Contact Information
Primary
Stefania Badiali
sbadiali@filinf.it
+39.059.9769912
Backup
Giorgio Priolo
gpriolo@filinf.it
+39.0131.033175
Time Frame
Start Date: 2022-03-21
Estimated Completion Date: 2029-03
Participants
Target number of participants: 49
Treatments
Experimental: Consolidation with ADCT-402 (loncastuximab tesirine) after a short course of immunochemotherapy
R/R MCL after one, two, three or four lines of treatment including BTKi treatment (or BTKi intolerant), with complete response (CR) or partial response (PR) or with stable disease (SD) after salvage immunochemotherapy (R-BAC, Rituximab - Bendamustine, Ara-C x 2 cycles) will undergo consolidation with loncastuximab tesirine. A patient with CR, PR or SD after one R-BAC course, which is unable to undergo a second course due to toxicity to chemotherapy, can be considered to proceed for consolidation.
Sponsors
Leads: Fondazione Italiana Linfomi - ETS

This content was sourced from clinicaltrials.gov