Status:
COMPLETED
The EMPATHY Pilot Study
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Cancer Institute (NCI)
Fondazione GIMEMA
Conditions:
Leukemia, Chronic Myeloid
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The proposed study, may significantly contribute to improve healthcare delivery in patients with Chronic Myeloid Leukemia (CML) treated with modern tyrosine kinase inhibitors (TKIs) in two ways. First...
Detailed Description
The evolution in the understanding of the biology of Chronic Myeloid Leukemia (CML), that eventually translated into highly effective molecular targeted therapies, is unparalleled in cancer medicine. ...
Eligibility Criteria
Inclusion
- Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis;
- Newly diagnosed chronic phase (CP)-CML Patients planned to receive one of the following TKI approved as first line treatment: imatinib, dasatinib, nilotinib or bosutinib;
- Adult Patients (≥18 years) at the time of study entry; Children under the age of 18 will be excluded from the study. The exclusion of children is justified by the following circumstances: a) The condition is relatively rare in children, as compared to adults; b) Issues of study preclude direct applicability of hypotheses and/or interventions to both adults and children.
- Written informed consent.
- Written informed consent from Patient's physician as a participant.
- Newly diagnosed Chronic Phase (CP)-CML Patients who are within 4 weeks of first line TKI therapy (anyone of the TKI approved in the USA and Europe, that is: imatinib, dasatinib, nilotinib or bosutinib).
- Ability to read/converse in English (Northwestern University and Augusta University Sites). Ability to read/converse in Italian (GIMEMA Centers).
- Patient exclusion criteria will include:
- Major cognitive deficits or psychiatric problems hampering a self-reported evaluation;
- Having received any CML treatment - other than TKI - for more than 3 months prior to receiving current TKI therapy.
- This project will focus on CML, which affect both men and women. Therefore, there are no exclusion/inclusion criteria based on sex/gender. In addition, there are no exclusion/inclusion criteria based on race and ethnicity.
- Physician inclusion criteria will include:
- 1)Provider of clinical care for Patient who meets inclusion criteria for the study
- Please note that Physician consent is requisite for the Patient to be enrolled as a participant in the study.
Exclusion
- Major cognitive deficits or psychiatric problems hampering a self-reported evaluation
- Having received any CML treatment prior to therapy with imatinib, dasatinib, bosutinib or nilotinib for more than three months
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT04384848
Start Date
November 1 2019
End Date
July 31 2022
Last Update
March 4 2024
Active Locations (16)
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1
Augusta University, Hematology and Oncology
Augusta, Georgia, United States, 30912
2
Northwestern University, Robert H. Lurie Comprehensive Cancer Center Comprehensive Cancer Center (RHLCCC)
Chicago, Illinois, United States, 60611
3
Policlinico Sant'Orsola Malpighi - UOC Ematologia - Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
4
Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO - Azienda Ospedaliera G. Brotzu
Cagliari, Italy