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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hôpital Avicenne
RECRUITING
Bobigny
Hopital Robert Debré
RECRUITING
Paris
Hôpital Saint Louis
RECRUITING
Paris
Contact Information
Primary
Hervé DOMBRET, Pr
herve.dombret@aphp.fr
1 57 27 68 47
Backup
Jérôme Lambert, Pr
jerome.lambert@u-paris.fr
142499742
Time Frame
Start Date: 2022-03-28
Estimated Completion Date: 2042-03
Participants
Target number of participants: 3000
Treatments
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.
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.
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.
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.
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov