Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients

Summary

The purpose of this study is to assess the capability of the dPCR technique to predict the absence of disease relapses after imatinib discontinuation in CML patients with negative Q-RT-PCR results for longer than 18 months.

Conditions

• Chronic Myeloid Leukemia

Interventions

DRUG

Imatinib mesylate

* Capsules, hard 50 or 100 mg/Film-coated Tablets 100 or 400 mg * Total dosage per day: 800 mg * Oral use

Sponsors & Collaborators

• University of Milano Bicocca

  lead OTHER

Principal Investigators

• Carlo Gambacorti-Passerini, MD · Azienda Ospedaliera San Gerardo di Monza

• Eros Di Bona, MD · Ospedale S. Bortolo (USSL 6)

• Francesco Di Raimondo, MD · Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele"

• Elisabetta Abruzzese, MD · Università di Tor Vergata Ospedale di S. Eugenio

• Luca Arcaini, MD · IRCCS Policlinico San Matteo Pavia

• Valeria Santini, MD · Università di Firenze Azienda Ospedaliera-Universitaria Careggi

• Bruno Martino, MD · A.O. Bianchi-Melacrino-Morelli

• Alessandra Iurlo, MD · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

• Arnon Nagler, MD · Chaim Sheba Medical Center

• Ester Pungolino, MD · Ospedale Niguarda Ca' Granda

• Philipp le Coutre, MD · Charité University of Berlin

• Sarit Assouline, MD · McGill University - Jewish General Hospital

• Onno Leeskma, MD · Onze Lieve Vrouwe Gasthuis

• Marcio Andrade, MD · Hospital Miguel Servet

• Micaela Bergamaschi, MD · IRCCS A.O.U. San Martino

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-11-09

Primary Completion

2018-11-28

Completion

2018-11-28

Countries

• Canada
• Germany
• Israel
• Italy
• Spain

Study Locations