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

NCT01578213 | Completed Phase 4

• 2 other identifiers: ISAV2011-002749-37
• Study Type: interventional
• Target: 112
• Locations: 5 countries
• Sites: 14

Brief 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

Outcome Measures

Primary Outcomes (1)

• The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR

  The capability of the dPCR method to predict relapse-free patients relative to the standard method. NPV of each method will be computed as the number of patients who are negative according to either method at the time of imatinib discontinuation and remain relapse-free 36 months later over the total of negative patients according to either method, respectively

  At 36 months.

Secondary Outcomes (8)

• Rate of molecular and cytogenetic relapse

  At 36 months

• Rate of dPCR positive patients

  At 36 months

• Rate of dPCR negative patients

  At 36 months

• Rate of patients who are maintaining dPCR negativity for 36 months

  At 36 months

• Time to molecular relapse

  At 36 months

Study Arms (1)

Imatinib

EXPERIMENTAL

Drug: Imatinib mesylate

Interventions

Imatinib mesylate DRUG

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

Also known as: Glivec, Gleevec

Imatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated IRB/IEC-approved Informed Consent
• Age\>=18 years
• Male or female patients with CML diagnosed in chronic or accelerated phase and who have been treated for more than 2 consecutive years with imatinib therapy
• Sustained Complete Molecular Response (as defined by the treating center) for at least 18 months with imatinib treatment
• A minimum of 3 CMR determined by Q-RT-PCR analysis to support disease status, with the list one performed within 3 calendar months prior to enrollment date
• Willingness and ability to comply with scheduled visits laboratory tests and other study procedures

You may not qualify if:

• Allogenic hematopoietic stem cell transplantation
• Known active infections including human immunodeficiency virus (HIV) positivity
• Current enrollment another clinical trial
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (14)

McGill University - Jewish General Hospital Division of Hematology and Department of Oncology

Montreal, Quebec, H3T 1E2, Canada

Location

Charité University of Berlin - Clinic of Medicine - Hematology and Oncology

Berlin, 13353, Germany

Location

Chaim Sheba Medical Center - Division of Hematology, BMT and CBB

Tel Litwinsky, 52621, Israel

Location

Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele"

Catania, Italy/Catania, 95124, Italy

Location

Università di Firenze Azienda Ospedaliera - Universitaria Careggi

Florence, Italy/Firenze, 50134, Italy

Location

Azienda Ospedaliera San Gerardo di Monza

Monza, Italy/MB, 20052, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC di Ematologia

Milan, Italy/Milano, 20162, Italy

Location

IRCCS Policlinico San Matteo Pavia - Istituto di Ematologia

Pavia, Italy/Pavia, 27100, Italy

Location

A.O. Bianchi-Melacrino-Morelli U.O. Ematologia

Reggio Calabria, Italy/Reggio Calabria, 89124, Italy

Location

Universita di Tor Vergata Ospedale S. Eugenio

Rome, Italy/Rome, 00142, Italy

Location

Ospedale S. Bortolo (USSL 6)

Vicenza, Italy/Vicenza, 36100, Italy

Location

Ospedale Niguarda Ca' Granda - U.O. Ematologia

Milan, MI, 20162, Italy

Location

IRCCS A.O.U. San Martino

Genova, 16132, Italy

Location

Hospital Universitario Miguel Servet - Hematologia

Zaragoza, Spain

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Carlo Gambacorti-Passerini, MD

  Azienda Ospedaliera San Gerardo di Monza

  STUDY DIRECTOR

• Eros Di Bona, MD

  Ospedale S. Bortolo (USSL 6)

  PRINCIPAL INVESTIGATOR

• Francesco Di Raimondo, MD

  Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele"

  PRINCIPAL INVESTIGATOR

• Elisabetta Abruzzese, MD

  Università di Tor Vergata Ospedale di S. Eugenio

  PRINCIPAL INVESTIGATOR

• Luca Arcaini, MD

  IRCCS Policlinico San Matteo Pavia

  PRINCIPAL INVESTIGATOR

• Valeria Santini, MD

  Università di Firenze Azienda Ospedaliera-Universitaria Careggi

  PRINCIPAL INVESTIGATOR

• Bruno Martino, MD

  A.O. Bianchi-Melacrino-Morelli

  PRINCIPAL INVESTIGATOR

• Alessandra Iurlo, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

• Arnon Nagler, MD

  Chaim Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Ester Pungolino, MD

  Ospedale Niguarda Ca' Granda

  PRINCIPAL INVESTIGATOR

• Philipp le Coutre, MD

  Charité University of Berlin

  PRINCIPAL INVESTIGATOR

• Sarit Assouline, MD

  McGill University - Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• Onno Leeskma, MD

  Onze Lieve Vrouwe Gasthuis

  PRINCIPAL INVESTIGATOR

• Marcio Andrade, MD

  Hospital Miguel Servet

  PRINCIPAL INVESTIGATOR

• Micaela Bergamaschi, MD

  IRCCS A.O.U. San Martino

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2012
• First Posted: April 16, 2012
• Study Start: November 9, 2011
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: December 3, 2019

Record last verified: 2019-11

Locations

CA (1); IT (10); DE (1); ES (1); IL (1)