NCT05326919 The Patient Cohort of the National Center for Precision Medicine in Leukemia
| NCT ID | NCT05326919 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Myeloid Leukemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2022-03-28 |
| Primary Completion | 2042-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2022-03-28 with a primary completion date of 2042-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05326919 clinical trial?
This trial is open to participants of all sexes, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05326919 currently recruiting?
Yes, NCT05326919 is actively recruiting participants. Contact the research team at herve.dombret@aphp.fr for enrollment information.
Where is the NCT05326919 trial being conducted?
This trial is being conducted at Bobigny, France, Paris, France, Paris, France.
Who is sponsoring the NCT05326919 clinical trial?
NCT05326919 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 3,000 participants.
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