NCT05326919Recruiting
The Patient Cohort of the National Center for Precision Medicine in Leukemia
Source: ClinicalTrials.gov · Last updated 29 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 28 Jan 2022
- Start date
- 28 Mar 2022
- Primary completion date
- Mar 2042
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Acute lymphoblastic leukaemia, Myeloproliferative neoplasms, Myelodysplastic syndromes, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT05326919
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 28 Mar 2022 to the primary completion date, Mar 2042
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hopital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Recruiting |
| Hopital Robert Debre Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hopital Saint Louis Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.