Logo
Make a donation
Make a donation

eTHEMA : The cohort of patients with leukemias

...

What is the eTHEMA cohort dedicated to leukemias?

This study consists in setting up a clinical and biological cohort of leukemias and related diseases (AML, ALL, high-risk MDS, or myelofibrosis linked to an MPN).

It is described as non-interventional since it does not expose you to any new medications, medical devices, or new tools.

To establish a prospective registry documenting the characteristics of these diseases, the treatments used, as well as the outcomes and the experiences of the patients receiving care.

This study will make it possible to evaluate, in a large patient cohort:

  • The short- and long-term outcomes of patients

  • Quality of life, assessed through your own responses to a specific questionnaire

  • The treatments that are proposed, among the various validated and authorized options currently available

  • The precise biological characteristics of the different cases of leukemias and related diseases, based on the study of bone marrow or blood cells, or of their molecular components (DNA, RNA, and proteins).

The collection, study, and preservation of biological material thus allows not only for choosing the most appropriate treatment for you and monitoring its effectiveness, but also for advancing general knowledge about these diseases and identifying patients eligible for future research.

Learn more

This cohort dedicated to leukemias will allow:

  • A better understanding of the mechanisms underlying leukemias,

  • The confirmation or discovery of new risk factors,

  • And the conduct of so-called ‘correlative’ biological studies carried out in the laboratory using the cells and serum collected from your blood and bone marrow during your routine exams, or their components (DNA, RNA, or proteins).

These additional volumes of blood and bone marrow will also allow the development of a collection of biological material: serum, cells, and nucleic acids (DNA and RNA) from these cells.

This biological material will be stored, after freezing, in the Biological Resource Center of Saint-Louis Hospital or Robert Debré Hospital, under the responsibility of Professors Jean SOULIER and Hélène CAVE, respectively.

It should be noted that studies conducted on the nucleic acids (DNA/RNA) will allow the exploration of gene mutations associated with your disease.

These analyses are not intended to identify ‘constitutional’ genetic abnormalities.

By participating in this cohort study, you will contribute to a better understanding of leukemias and related diseases, their biological characteristics, the choice of treatments and the treatments actually received, as well as the outcomes of patients receiving care, including long-term outcomes and quality of life.

Your participation is unlikely to provide you with a direct benefit other than contributing to research that ensures the standardization of care and the precise study of your disease characteristics according to the best current standards.

In the future, the data collected in this study may provide a more precise understanding of the characteristics of the disease and the patients, leading to the development of better individualized and more effective treatments from which new patients may benefit.

Participation in this study will not change the choice or nature of the treatment offered to you.

It does not require any specific examinations or additional visits, in particular no extra blood draws or bone marrow samples, beyond those performed as part of the usual monitoring of your disease and treatment.

However, each time these examinations are necessary for your care, whether during your initial treatment or follow-up, an additional volume of blood and bone marrow may be collected to carry out complementary biological research.

This research will notably include the analysis of the sensitivity of leukemic cells to the different available drugs (functional cytometry platform at Saint-Louis Hospital), with the aim of improving treatment possibilities for future patients. These volumes will, however, not exceed 50 ml of blood and 4 ml of bone marrow in total.

It is expected that approximately 2,500 to 3,000 patients will participate in the development of this cohort dedicated to leukemias.

Your individual participation in the study is 15 years, allowing your outcomes, and those of your disease, to be documented over the long term.

The study is planned to remain open for patient inclusion for a period of 5 years.

Your participation in this study is voluntary.

Furthermore, you are free to withdraw from the study at any time.

This can in no way affect your relationship with your doctor or the quality of care you receive.

Main inclusion and exclusion criteria

  • Patient with newly diagnosed de novo, secondary, or treatment-related leukemia, or with related untreated conditions, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), and myelofibrosis associated with myeloproliferative neoplasms (MPN)

  • Patient informed and not opposed to participation
  • Affiliation with social security or health insurance

  • Related conditions whose morphology is not confirmed (patients with granulocytic sarcoma may be included)

  • Prior treatment of related conditions except for:
  • Hydroxyurea or prior treatment of myelodysplastic syndrome/myeloproliferative neoplasms in patients with acute myeloid leukemia (AML)
  • Steroids, vincristine, prophylactic or therapeutic intrathecal injection, or prior treatment of chronic myeloid leukemia (CML) in ALL patients
  • Erythroid-stimulating agents (ESA), luspatercept, granulocyte colony-stimulating factor (G-CSF), eltrombopag or other TPO agonists, iron chelation therapy, hypomethylating agents (HMA), lenalidomide, or any other experimental drug previously used to treat high-risk MDS in HR-MDS patients
  • Hydroxyurea, standard or pegylated interferon alpha, ruxolitinib or other JAK inhibitors, busulfan, anagrelide, ESA, or any experimental drug previously used to treat MPN in patients with myelofibrosis associated with myeloproliferative neoplasms

 

  • Patient under guardianship or curatorship
  • Patient covered by state medical aid (AME)
  • Patient opposes inclusion in the eTHEMA cohort

Information sheet for adult patients

Volunteering

Contact the trial coordination team