Observes how adults with acute myeloid leukemia are treated and how they fare

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 adults with acute myeloid leukemia (AML), either newly diagnosed and untreated, or whose AML came back or did not respond to treatment. It only follows patients and documents their care.

Age

18 years or older

Sex

All sexes can join

Disease stage

Newly diagnosed, previously untreated AML (de novo, secondary or therapy-related), or relapsed/refractory AML

Earlier treatment

For newly diagnosed AML, no earlier leukemia treatment except hydroxyurea. Earlier anti-leukemia treatment is allowed if it was given before the AML diagnosis for MDS, MPN, MPN/MDS or CML.

Main reasons for not taking part

• Acute promyelocytic leukemia
• AML not proven by morphology (granulocytic sarcoma may be included)
• Weight under 50 kg (110 lb)
• Patient refuses to take part in the study

The registry criteria, word for word

What the trial wants to find out

During the last fifteen years, the landscape of AML diagnosis and therapeutical options has markedly evolved. Refined genetic and prognostic characterizations, together with new drug approvals and new allogeneic hematopoietic stem cell transplantation (HSCT) procedures, have increased patient journey diversity.

The 5 groups in the trial

• Standard intensive 3+7 YOUNG OR ELDERLY

  Standard intensive 3+7 (anthracycline + cytarabine) chemotherapy ± an approved FLT3 inhibitor (midostaurine, Rydapt® or ± quizartinib, Vanflyta®), according to different dose schedules in older versus younger patients

• GO, (Mylotarg®) with 3+7

  Combination of sequential gemtuzumab ozogamicin (GO, Mylotarg®) with 3+7

• CPX-351, (Vyxeos®)

  Liposomal formulation of daunorubicin + cytarabine (CPX-351, Vyxeos®)

• Less intensive chemotherapy with azacytidine combined or not with venetoclax; LDAC; ivosidenib

  Less intensive chemotherapy with azacytidine either combined or not with venetoclax or low dose cytarabine (LDAC) or in AML bearing an IDH1 somatic mutation, with ivosidenib in newly diagnosed patients considered as not eligible for the more intensive options above

• Refractory or relapsed AML

  Secondly, no specific salvage regimen has emerged as a standard in patients with primary refractory or relapsed AML (R/R AML). R/R AML is thus an important field for investigational new drugs (INDs) and precision medicine development. To date, the only IND approved to treat R/R AML is gilteritinib for FLT3-mutated AML patients. The French agency ANSM also allow to use GO for treating R/R AML patients in the frame of a RTU (Recommendation Temporaire d'Utilisation). In the "real life", because of the multiplicity of treatments used in these patients, some of them being now quite efficient, it has become difficult to accurately describe the general outcome of R/R AML patients.