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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca
ClinicalTrials.gov Identifier:
NCT01578213
First received: April 13, 2012
Last updated: May 14, 2014
Last verified: May 2014

April 13, 2012
May 14, 2014
November 2011
November 2016   (final data collection date for primary outcome measure)
The Negative Predicted Value Ratio (rNPV) of dPCR over Q-RT-PCR [ Time Frame: At 36 months. ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01578213 on ClinicalTrials.gov Archive Site
  • Rate of molecular and cytogenetic relapse [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
    Rate of molecular and cytogenetic relapse after discontinuation of imatinib treatment out of total number of patients enrolled
  • Rate of dPCR positive patients [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
    Rate of patients who are dPCR positive before discontinuation of imatinib and who do not relapse within the following 36 months (false positive) out of the total number of relapse-free patients at month 36.
  • Rate of dPCR negative patients [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
    Rate of patients who are dPCR negative before discontinuation of imatinib and who relapse (false negative) out of the total number of patients relapsing within the following 36 months.
  • Rate of patients who are maintaining dPCR negativity for 36 months [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
    Rate of patients who are maintaining dPCR negativity for 36 months over the patients who are Q-RT-PCR negative at the end of the interval.
  • Time to molecular relapse [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
    Time to molecular relapse, both from the first PCR-negative and from the discontinuation of imatinib to the time of loss of molecular response, respectively.
  • Overall Survival [ Time Frame: At the end of the study ] [ Designated as safety issue: No ]
    Overall Survival
  • Quality of Life [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
    Quality of Life, as measured by the Global Health Status\QOL and other subscales scores of EORTC-QLQ-C30 questionnaire
  • Rate of patients progressing or developing resistance [ Time Frame: At 36 months ] [ Designated as safety issue: No ]
    Rate of patients progressing or developing resistance after imatinib resumption out of total number of patients enrolled
Same as current
Not Provided
Not Provided
 
Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients
Validation of Digital-PCR Analysis Through Programmed Imatinib Interruption in PCR Negative CML Patients (ISAV)

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Chronic Myeloid Leukemia
Drug: Imatinib mesylate
  • Capsules, hard 50 or 100 mg/Film-coated Tablets 100 or 400 mg
  • Total dosage per day: 800 mg
  • Oral use
Other Name: Glivec, Gleevec
Experimental: Imatinib
Intervention: Drug: Imatinib mesylate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
November 2018
November 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   Israel,   Italy,   Netherlands,   Spain
 
NCT01578213
ISAV, 2011-002749-37
No
University of Milano Bicocca
University of Milano Bicocca
Not Provided
Study Director: Carlo Gambacorti-Passerini, MD Azienda Ospedaliera San Gerardo di Monza
Principal Investigator: Anna D'Emilio, 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: Ester Orlandi, 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: Enrica Morra, 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: Pilar Giraldo, MD Hospital Universitario Miguel Servet
Principal Investigator: Ivana Pierri, MD IRCCS A.O.U. San Martino
University of Milano Bicocca
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP