Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients

PHASE2RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

October 5, 2022

Primary Completion Date

February 1, 2025

Study Completion Date

July 1, 2028

Conditions
ChemotherapyLeukemia, Acute Lymphoblastic
Interventions
DRUG

Ponatinib

Ponatinib is a novel, synthetic, orally-active TKI discovered using a computational and structure based drug design approach. Ponatinib was specifically designed to inhibit all clinically relevant variants of BCR-ABL1, including the T315I mutant (15-17). In vitro assays have demonstrated that Ponatinib potently inhibits the kinase enzymatic activity of the T315I ABL kinase domain, as well as that of the native (unmutated) enzyme. In leukemia cell lines expressing these BCR-ABL1 variants, Ponatinib potently inhibited BCR-ABL1 signaling, leading to the reduction of cellular proliferation and induction of apoptosis. Ponatinib also inhibits the proliferation of cell lines expressing other major clinically-observed Imatinib-resistant mutants of BCR-ABL1.

Trial Locations (24)

83100

RECRUITING

Ematologia con Unità di Trapianto, Avellino

Unknown

RECRUITING

Ematologia Presidio Ospedaliero Tortora, Pagani

RECRUITING

Ematologia ASST Papa Giovanni XXIII, Bergamo

RECRUITING

Ematologia AOU S.ORSOLA-MALPIGHI, Bologna

RECRUITING

Ematologia ASST Spedali Civili, Brescia

RECRUITING

Ematologia AOU Policlinico Vittorio Emanuele-Ferrarotto, Catania

RECRUITING

Ematologia AOU Careggi, Florence

RECRUITING

Ematologia Ospedale V.Fazzi, Lecce

RECRUITING

Ematologia Ospedale dell'Angelo, Mestre

RECRUITING

Ematologia Ospedale Maggiore Policlinico, Milan

RECRUITING

Ematologia AOU Federico II, Napoli

RECRUITING

Ematologia AOU Maggiore della Carità, Novara

RECRUITING

Ematologia AO Ospedali Riuniti Villa Sofia Cervello, Palermo

RECRUITING

Ematologia Fondazione Policlinico San Matteo, Pavia

RECRUITING

Ematologia Presidio Ospedaliero Spirito Santo, Pescara

RECRUITING

Ematologi Presidio Ospedaliero Guglielmo da Saliceto, Piacenza

RECRUITING

Ematologia Presidio Ospedaliero Infermi, Rimini

RECRUITING

Dipartimento di Medicina Traslazionale e di Precisione - Ematologia, Roma

RECRUITING

Ematologia AOU Policlinico Tor Vergata, Roma

RECRUITING

Ematologia Policlinico A.Gemelli, Roma

RECRUITING

Ematologia AOU Senese, Siena

RECRUITING

Ematologia Ospedale Mauriziano, Torino

RECRUITING

Ematologia Ospedale S.Giovanni Battista Molinette, Torino

RECRUITING

Ematologia Policlinico G.B. Rossi, Verona

All Listed Sponsors
lead

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER