Status:

RECRUITING

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

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Eligibility:

All Genders

Brief 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 i...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

March 28 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2042

Estimated Enrollment :

3000 Patients enrolled

Trial Details

Trial ID

NCT05326919

Start Date

March 28 2022

End Date

March 1 2042

Last Update

May 29 2024

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Hôpital Avicenne

Bobigny, France

2

Hopital Robert Debré

Paris, France

3

Hôpital Saint Louis

Paris, France