The Patient Cohort of the National Center for Precision Medicine in Leukemia

Last updated: May 26, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Acute Myeloid Leukemia

Myelodysplastic Syndromes (Mds)

Treatment

Biobanking

Clinical Study ID

NCT05326919
APHP210850
  • All Genders

Study Summary

If for years the treatment strategy of leukemia and related disorders (LRDs, including acute leukemias and predisposition syndromes) has been based solely on whether the patient could receive or not intensive chemotherapy and transplantation, the advent of new targeted or less targeted drugs has led to the development of a growing number of new therapeutic approaches, very often offered to specific patient/disease subsets, justifying the generic term of 'precision medicine'.

As an international leukemia center of excellence, THEMA, the French National Center for Precision Medicine in Leukemia (selected as IHUB-2 by the French National Agency for Research), is a care, research, transfer and education initiative located at the Saint-Louis Research Institute (IRSL) in Paris and devoted to precision medicine in leukemia in a real-life environment.

The present non-interventional study (eTHEMA) is a pillar of the whole THEMA project. As a prerequisite for precision medicine, this program focuses on individual data collection, aiming to collect high-quality data not only in patients treated into prospective clinical trials, but in every THEMA patient with a special interest in outpatients' care and research.

The primary objective of this non-interventional study is to describe the baseline characteristics planned treatments and outcomes of patients newly diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient with newly diagnosed previously untreated de novo, secondary ortherapy-related leukemia or related disorders (LRD), including AML, ALL, HR-MDS (according to the international score IPSS), and MNP-related myelofibrosis

  • Patient informed and not opposed to participating

  • Affiliation to social security or any health insurance

Exclusion

Exclusion Criteria:

  • LRD which is not morphologically proven (patients with granulocytic sarcoma may beincluded)

  • Previous treatment for LRD, apart from:

  • Hydroxyurea or previous MDS/MPN-CML therapy in AML patients

  • Steroids, vincristine, intrathecal prophylactic or curative injection orprevious CML therapy in ALL patients

  • Erythroid stimulating agents (ESAs), luspatercept, granulocytecolony-stimulating factor (G-CSF), eltrombopag or other TPO agonist, ironchelation therapy, hypomethylating agents (HMAs), lenalidomide or anyinvestigational drug previously used to treat MDS in HR-MDS patients

  • Hydroxyurea, standard or pegylated interferon alpha, ruxolitinib or other JAKinhibitors, busulfan, anagrelide, ESAs or any investigational drug previouslyused to treat MPN in MPN-related myelofibrosis patients

  • Patient under guardianship / curatorship

  • Patient under AME

  • Opposition of the patient to be enrolled in the eTHEMA cohort

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Biobanking
Phase:
Study Start date:
March 28, 2022
Estimated Completion Date:
March 31, 2042

Connect with a study center

  • Hôpital Avicenne

    Bobigny,
    France

    Active - Recruiting

  • Hopital Robert Debré

    Paris,
    France

    Active - Recruiting

  • Hôpital Saint Louis

    Paris,
    France

    Active - Recruiting

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