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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002749-37 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imatinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imatinib mesylate | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of molecular and cytogenetic relapse | Rate of molecular and cytogenetic relapse after discontinuation of imatinib treatment out of total number of patients enrolled | At 36 months |
| Rate of dPCR positive patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University - Jewish General Hospital Division of Hematology and Department of Oncology | Montreal | Quebec | H3T 1E2 | Canada | ||
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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.
| At 36 months |
| Rate of dPCR negative patients | 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. | At 36 months |
| Rate of patients who are maintaining dPCR negativity for 36 months | 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. | At 36 months |
| Time to molecular relapse | 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. | At 36 months |
| Overall Survival | Overall Survival | At the end of the study |
| Quality of Life Assessment | Quality of Life, as measured by the Global Health Status\QOL and other subscales scores of EORTC-QLQ-C30 questionnaire | At 36 months |
| Rate of patients progressing or developing resistance | Rate of patients progressing or developing resistance after imatinib resumption out of total number of patients enrolled | At 36 months |
| 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 |
| Charité University of Berlin - Clinic of Medicine - Hematology and Oncology |
| Berlin |
| 13353 |
| Germany |
| Chaim Sheba Medical Center - Division of Hematology, BMT and CBB | Tel Litwinsky | 52621 | Israel |
| Azienda Ospedaliero-Universitaria "Policlinico-Vittorio Emanuele" | Catania | Italy/Catania | 95124 | Italy |
| Università di Firenze Azienda Ospedaliera - Universitaria Careggi | Florence | Italy/Firenze | 50134 | Italy |
| Azienda Ospedaliera San Gerardo di Monza | Monza | Italy/MB | 20052 | Italy |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC di Ematologia | Milan | Italy/Milano | 20162 | Italy |
| IRCCS Policlinico San Matteo Pavia - Istituto di Ematologia | Pavia | Italy/Pavia | 27100 | Italy |
| A.O. Bianchi-Melacrino-Morelli U.O. Ematologia | Reggio Calabria | Italy/Reggio Calabria | 89124 | Italy |
| Universita di Tor Vergata Ospedale S. Eugenio | Rome | Italy/Rome | 00142 | Italy |
| Ospedale S. Bortolo (USSL 6) | Vicenza | Italy/Vicenza | 36100 | Italy |
| Ospedale Niguarda Ca' Granda - U.O. Ematologia | Milan | MI | 20162 | Italy |
| IRCCS A.O.U. San Martino | Genova | 16132 | Italy |
| Hospital Universitario Miguel Servet - Hematologia | Zaragoza | Spain |
| ID | Term |
|---|---|
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068877 | Imatinib Mesylate |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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