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

NCT ID: NCT01578213

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-09
• Study Completion Date: 2018-11-28

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.

Detailed Description

This study will recruit approximately 100 CML patients under imatinib therapy in complete molecular remission with a history of at least 18 months of consecutive negative standard Q-RT-PCR as performed in their own centers. After signing the informed consent form (ICF), the patients will be tested for dPCR and will discontinue imatinib therapy. Then they will be monitored by standard Q-RT-PCR to assess the maintenance of the molecular remission; collection of data will be prospective as each center will collect the data for 36 months. At the end of this period, a peripheral blood sample for dPCR analysis will be obtained from those patients who will still have undetectable BCR-ABL transcripts by Q-RT-PCR to verify CML eradication. The maintenance of molecular remission by Q-RT-PCR and the survival will be monitored every six months during an additional follow-up of 24 months. Patients found to be positive to BCR-ABL transcripts by standard Q-RTPCR will repeat the test every 2 to 4 weeks until the loss of molecular remission, defined as two consecutive BCR-ABL positive tests with at least one with BCR-ABL/BCR value above 0.1%, or until the end of the study, whichever come first.

Conditions

Chronic Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Imatinib

Group Type: EXPERIMENTAL

Imatinib mesylate

Intervention Type: DRUG

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

Interventions

Imatinib mesylate

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

Intervention Type: DRUG

Other Intervention Names

Glivec, Gleevec

Eligibility Criteria

Inclusion Criteria

1. Signed and dated IRB/IEC-approved Informed Consent

2. Age>=18 years

3. 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

4. Sustained Complete Molecular Response (as defined by the treating center) for at least 18 months with imatinib treatment

5. 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

6. Willingness and ability to comply with scheduled visits laboratory tests and other study procedures

Exclusion Criteria

1. Allogenic hematopoietic stem cell transplantation

2. Known active infections including human immunodeficiency virus (HIV) positivity

3. Current enrollment another clinical trial

4. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milano Bicocca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlo Gambacorti-Passerini, MD

Role: STUDY_DIRECTOR

Azienda Ospedaliera San Gerardo di Monza

Eros Di Bona, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale S. Bortolo (USSL 6)

Francesco Di Raimondo, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria "Policlinico - Vittorio Emanuele"

Elisabetta Abruzzese, MD

Role: PRINCIPAL_INVESTIGATOR

Università di Tor Vergata Ospedale di S. Eugenio

Luca Arcaini, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Policlinico San Matteo Pavia

Valeria Santini, MD

Role: PRINCIPAL_INVESTIGATOR

Università di Firenze Azienda Ospedaliera-Universitaria Careggi

Bruno Martino, MD

Role: PRINCIPAL_INVESTIGATOR

A.O. Bianchi-Melacrino-Morelli

Alessandra Iurlo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Arnon Nagler, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Ester Pungolino, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Niguarda Ca' Granda

Philipp le Coutre, MD

Role: PRINCIPAL_INVESTIGATOR

Charité University of Berlin

Sarit Assouline, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University - Jewish General Hospital

Onno Leeskma, MD

Role: PRINCIPAL_INVESTIGATOR

Onze Lieve Vrouwe Gasthuis

Marcio Andrade, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Miguel Servet

Micaela Bergamaschi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS A.O.U. San Martino

Locations

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

Montreal, Quebec, Canada

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

Berlin, , Germany

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

Tel Litwinsky, , Israel

Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele"

Catania, Italy/Catania, Italy

Università di Firenze Azienda Ospedaliera - Universitaria Careggi

Florence, Italy/Firenze, Italy

Azienda Ospedaliera San Gerardo di Monza

Monza, Italy/MB, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC di Ematologia

Milan, Italy/Milano, Italy

IRCCS Policlinico San Matteo Pavia - Istituto di Ematologia

Pavia, Italy/Pavia, Italy

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

Reggio Calabria, Italy/Reggio Calabria, Italy

Universita di Tor Vergata Ospedale S. Eugenio

Rome, Italy/Rome, Italy

Ospedale S. Bortolo (USSL 6)

Vicenza, Italy/Vicenza, Italy

Ospedale Niguarda Ca' Granda - U.O. Ematologia

Milan, MI, Italy

IRCCS A.O.U. San Martino

Genova, , Italy

Hospital Universitario Miguel Servet - Hematologia

Zaragoza, , Spain

Countries

Canada; Germany; Israel; Italy; Spain

Other Identifiers

2011-002749-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ISAV

Identifier Type: -

Identifier Source: org_study_id