Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Myeloid Leukemia

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Amino Acids

Tyrosine Kinase Inhibitors

Tyrosine

Patients with Chronic Myeloid Leukemia taking TKI with a molecular response \< 4,5 Log will participate to pharmaceutical conciliation.

Patients with pharmacokinetic and/or pharmacodynamics interactions will be proposed to participate to educational sessions to discuss about treatments taken and modifications possibilities.

Pharmaceutical intervention

Sandrine Menguy, MD, PhD

Mathilde Maison, MsC

Denis GUYOTAT

Karine AUGEUL MEUNIER

Silvia Maria BEZSERA

Emilie CHALAYER

Philippe COLLET

Jérôme CORNILLON

Ludovic FOUILLET

Fressia HONEYMAN

Caroline LEJEUNE

Thierry MURON

Gilbert SOGLU

Emmanuelle TAVERNIER TARDY

Pauline DOUCEY

Fabien FORGES

Sophie KALFON

Agnès MACE

The aim of this trial is therefore to identify concomitant treatments with taking Tyrosine Kinase Inhibitor (=TKI) in the indication of Chronic Myeloid Leukemia (CML), whatever the stage of the disease, via pharmaceutical conciliation. These concomitant treatments as well as their dosages will be correlated with the TKI dosage since patients must have a sufficient residual concentration to be considered effective and to confirm adherence to treatment, the leading cause of treatment failure.

In the event of unsatisfactory results, pharmaceutical interventions may take place: changes in treatments (TKI and not TKI) and / or dosages. In case of modification, a new dosage of TKI should be carried out.

Chronic myeloid leukemia (CML) is a clonal myeloproliferative syndrome with an estimated incidence of 0.8-1 cases per 100,000 person-years in 2018 in France. CML is characterized by the transformation of a pluripotent stem cell resulting in an increase in myeloid and erythroid lineages and megakaryocytes in peripheral blood as well as myeloid hyperplasia in the bone marrow.

In the absence of treatment, the disease, which begins in a chronic phase over a few years, progresses to an acceleration phase, before reaching an acute phase, known as a blast crisis, with a poor prognosis. This abnormal proliferation of white blood cells results from the reciprocal translocation (exchange) between chromosomes 9 and 22. This exchange brings two normally distinct genes into contact: the (breakpoint cluster region) BCR gene and the abl gene (Tyrosine-protein kinase), which will form an abnormal gene called "fusion Bcr-abl". This gene encodes a fusion protein with deregulated tyrosine kinase activity that activates various mechanisms involved in cell multiplication.

Since the 1990s, the arrival of the first tyrosine kinase inhibitor (TKI), imatinib, has radically changed patient management. Indeed, according to Public Health France, this treatment has allowed the majority of patients to remain in the chronic phase for a long time. Patient survival has therefore increased dramatically as the life expectancy of patients with CML taking their treatment regularly approaches that of the general population.

However, even though several generations of TKI have been developed, certain toxicities may lead to discontinuation of treatment, or to a modification of the dose. Indeed, a meta-analysis published in June 2020 shows that second and third generation of TKI improve the major molecular response by 3 months, but are associated with a recrudescence of thrombocytopenia, cardiovascular, pancreatic and hepatic events. First generation imatinib therefore remains the best option for patients with co-morbidities despite the frequent presence of headaches, digestive disorders, and cramps.

It has therefore always been customary to change the TKI or modify the prescribed doses, while the side effects or ineffectiveness of these inhibitors could be explained by drug interactions, or be related to the use of herbal medicine. Indeed, TKIs are metabolized by the cytochrome P450 system. The activity of this cytochrome is not only different from one person to another, but can also be affected by other treatments. For example, some treatments will inhibit the activity of this cytochrome P450, increasing the exposure of TKIs in plasma. The pharmacokinetics of the drug will therefore depend on these concomitant treatments and their influence, among others, on cytochrome P450.

In addition, the median age at diagnosis is respectively 61 years for men and 62 years for women. These patients are therefore often carriers of other chronic diseases and are have multiple treatments.

Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia

Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia: PHARM-LMC Study

Number of patients for whom pharmaceutical interventions have been done secondly to pharmaceutical conciliation will be reported.

Molecular response will be reported via BCR-ABL transcript rate measured by quantitative polymerase chain reaction (qPCR) or digital polymerase chain reaction (PCR).

Concomitant treatments will be reported during 12 months.

Observance to Tyrosine kinase inhibitor will be measured with Girerd Questionnaire.

Number and description of sides effects will be reported.

Patients' satisfaction will be measured with a visual scale from 0 to 10.

Patients' quality of life will be measured with the Quality of Life questionnaires (QLQ-C30) questionnaire. The maximum score is 126, the minimum score is 30. More the score is, worst the health state is.

Institut de Cancérologie de la Loire

Centre Hospitalier Universitaire de Saint Etienne

Behaviors and Mental Disorders

Hematologic Neoplasms

Quality of Life

Patients treated with anti-cancer oral therapy who benefit a specific pharmaceutical follow-up by the healthcare facilities pharmacist and by the dispensary pharmacist

Patients treated with anti-cancer oral therapy who who do not benefit from an additional pharmaceutical intervention

The coordinated experimental pharmaceutical path consists of 7 pharmaceutical interviews or consultations. One initial pharmaceutical consultation with the hospital pharmacist. Five follow-up pharmaceutical interviews with the dispensary pharmacist. One follow-up pharmaceutical consultation with hospital pharmacist.

Each pharmaceutical interview or consultation will result in the drafting of a pharmaceutical report to be sent to the other participating health professionals. At each pharmaceutical consultation or interview, the pharmacists requested perform a clinical pharmaceutical analysis of drug prescriptions; Evaluate the patient's understanding; Detect adherence problems, Identify drug related problems; Alert the oncologist and / or the attending physician.

IPPACTTO

Fanny D'ACREMONT-JUTIER

Emilie DEBEAUPUIS

Elouen BOUGHALEM, MD

Mathilde HUNAULT Mathilde, MD

Victor SIMMET, MD

Nadine MORINEAU Nadine, MD

Oana COJOCARASU, MD

Nicolas BLIN, MD

Emmanuelle BOURBOULOUX, MD

The rise of oral therapies in the management of cancers has considerably changed the patient care path. If the oral route is preferred by patients because it offers a better quality of life, it is not without impact for patients and the health professionals involved in their management in their care. Indeed, the use of the oral route shifts part of the responsibility for monitoring treatment towards the patient, thereby leading to compliance problems, drug interactions and the management of adverse effects.These risks can cause complications or compromise the effectiveness of treatment, and generate additional costs for the investigator's health system. The study proposes to involve Healthcare Facilities Pharmacist and the Dispensary Pharmacist with all other health professionals.First, the hospital pharmacist will operate before the initiation of an oral route to perform a clinical pharmaceutical analysis of drug prescriptions. Then after the primary prescription and finally during a follow-up consultation 3 months after the initiation of treatment. The hypothesis of the study is that the coordinated intervention of the hospital pharmacist and of the dispensary pharmacist would improve the tolerance of oral treatments by reducing the number of serious adverse effects found, as well as improve the, quality of life, patient and professional satisfaction

Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy

Pharmaceutical Intervention in the Coordinated Care Pathway for Cancer Patients Treated With Oral Therapy

The impact on tolerance will be measured by the proportion of patients with at least one grade 3 or 4 adverse event occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

The impact will be measured by the number of grade 3 and 4 adverse events occurring / confirmed, linked to oral therapy, and confirmed by the oncologist.

Number of unplanned hospitalizations related to the oral therapy and confirmed by the oncologist.

Number and nature of potential and confirmed drug related problemS detected by pharmacists

Number of treatment modifications related to oral therapy, necessary before starting treatment and during oral therapy and confirmed by the oncologist during follow-up consultations

Quality of life for patients will be evaluated by a questionnaire before and after starting oral therapy according to the The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire

Adherence to the oral therapy measured with the Girerd questionnaire wich is composed of 6 questions with an expected answer yes or no. A "yes" answer is worth 1, "No" answer is worth 0. The maximum score obtained is 6; the minimum score is 0. Final Score\> 2: low compliance ; Final score = 1 or 2: average compliance ; Final score = 0: good compliance.

Satisfaction of patients will be evaluated by a series of questions related to oral therapy. The patient responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree. An overall score is also required between 1 and 10; 1 is very bad; 10 is perfect

Evaluation of the link will be performed by a questionnaire to be completed by the oncologist and pharmacists. Each responds if he strongly disagrees; rather disagree; somewhat agree ; Totally agree

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia	NCT05130138	Chronic Myeloid...	Pharmaceutical ...	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Interest of PHARMaceutical Conciliation to Understand Drug Interactions, Phytotherapy, and Targeted Therapies in Chronic Myeloid Leukemia	NCT05130138	Chronic Myeloid...	Pharmaceutical ...	18 Years -	Centre Hospitalier Universitaire de Saint Etienne
Impact of the Coordinated Intervention of the Healthcare Facilities Pharmacist and the Dispensary Pharmacist on the Care Pathway for Cancer Patients Treated With Oral Therapy	NCT04327583	Advanced or Met... Relapsed Hemato...	IPPACTTO	18 Years -	Institut Cancerologie de l'Ouest

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