Actively Recruiting

All Genders
NCT05326919

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-29

3000

Participants Needed

3

Research Sites

1039 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with newly diagnosed previously untreated de novo, secondary or therapy-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
Not Eligible

You will not qualify if you...

  • LRD which is not morphologically proven (patients with granulocytic sarcoma may be included)
  • Previous treatment for LRD, apart from:
    • Hydroxyurea or previous MDS/MPN-CML therapy in AML patients
    • Steroids, vincristine, intrathecal prophylactic or curative injection or previous CML therapy in ALL patients
    • Erythroid stimulating agents (ESAs), luspatercept, granulocyte colony-stimulating factor (G-CSF), eltrombopag or other TPO agonist, iron chelation therapy, hypomethylating agents (HMAs), lenalidomide or any investigational drug previously used to treat MDS in HR-MDS patients
    • Hydroxyurea, standard or pegylated interferon alpha, ruxolitinib or other JAK inhibitors, busulfan, anagrelide, ESAs or any investigational drug previously used 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Hôpital Avicenne

Bobigny, France

Actively Recruiting

2

Hopital Robert Debré

Paris, France

Actively Recruiting

3

Hôpital Saint Louis

Paris, France

Actively Recruiting

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Research Team

H

Hervé DOMBRET, Pr

CONTACT

J

Jérôme Lambert, Pr

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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