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Taking people in FranceNo phase

Collects data and samples from patients with leukemia and related blood disorders

Gathers information on patients with leukemia or related blood disorders receiving routine care.

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
Bobigny and Paris, FranceSee the 3 sites
Trial code
Registry title
The Patient Cohort of the National Center for Precision Medicine in Leukemia
Status
Recruiting
People taking part
3,000 people, planned
Started
28 Mar 2022
Expected to end
Mar 2042
Type of study
Observational, 4 groups
Treatments tested
  • Biobanking
Record updated
29 May 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people newly diagnosed with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome or myelofibrosis linked to a myeloproliferative neoplasm, who have not been treated before. It records their data and outcomes under standard care.

Sex
All sexes can join.
Disease stage
Newly diagnosed leukemia or related disorder: AML, ALL, high-risk MDS (by the IPSS score) or myelofibrosis linked to a myeloproliferative neoplasm. It can be de novo, secondary or therapy-related.
Earlier treatment
No earlier treatment for the disease, apart from a few listed exceptions. Examples are hydroxyurea in AML, or steroids and vincristine in ALL.

Main reasons for not taking part

  • Disease not proven under the microscope (granulocytic sarcoma can be included)
  • Earlier treatment for the disease, beyond the listed exceptions
  • Person under guardianship or curatorship
  • Person under AME
  • Person who opposes joining the cohort

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • LRD which is not morphologically proven (patients with granulocytic sarcoma may be included)
  • Patient under guardianship / curatorship
  • Patient under AME
  • Opposition of the patient to be enrolled in the eTHEMA cohort

Where in France

  • Hopital AvicenneBobigny, FranceContact: Thorsten Braun, PrTaking people
  • Hopital Robert DebreParis, FranceContact: André Baruchel, PrTaking people
  • Hopital Saint LouisParis, FranceContact: Hervé Dombret, PrTaking people

About the trial

What the trial wants to find out

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'.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Acute myeloid Leukemia (AML)

    Standard and routine care. For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored.

    Treatment: Biobanking

  • Acute lymphoblastic leukemia (ALL)

    Standard and routine care. For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored.

    Treatment: Biobanking

  • High-risk myelodysplastic syndrome (MDS)

    Standard and routine care. For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored.

    Treatment: Biobanking

  • Myeloproliferative neoplasm -related myelofibrosis

    Standard and routine care. For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored.

    Treatment: Biobanking

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Patient Cohort of the National Center for Precision Medicine in Leukemia
Plain-language title
Collects data and samples from patients with leukemia and related blood disordersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 May 2024