IMPACT-AML: A RANDOMIZED PRAGMATIC CLINICAL TRIAL FOR RELAPSE OR REFRACTORY ACUTE MYELOID LEUKEMIA
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Leucemia mieloide aguda, Linfoma, Leucemia
FECHA DE APERTURA
Diciembre, 2024
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
Non-APL AML defined according WHO 2022 (or ICC 2022) criteria
1st or 2nd relapse or refractory according to ELN 2022
Patient is clinically candidate both to low intensity therapy and to high dose chemotherapy in the opinion of the physician
Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
No specific treatment protocol can be rationally considered better suited to patient needs. This specifically include, but is not limited to i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization
Male or Female, aged>18 years
ECOG performance status <4
A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline Recommendation related to contraception and pregnancy testing in clinical trials. Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline Recommendation related to contraception and pregnancy testing in clinical trials. Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.
Participant is willing and able to give informed consent for participation in the study
1st or 2nd relapse or refractory according to ELN 2022
Patient is clinically candidate both to low intensity therapy and to high dose chemotherapy in the opinion of the physician
Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
No specific treatment protocol can be rationally considered better suited to patient needs. This specifically include, but is not limited to i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization
Male or Female, aged>18 years
ECOG performance status <4
A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline Recommendation related to contraception and pregnancy testing in clinical trials. Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline Recommendation related to contraception and pregnancy testing in clinical trials. Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.
Participant is willing and able to give informed consent for participation in the study
CRITERIOS DE EXCLUSIÓN
Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of SmPC (e.g. hypersensitivity, allergy, organ failure precluding treatment)
Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization.
Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.
Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization.
Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.
DESCRIPCIÓN
To determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy
PALABRAS CLAVE
acute myeloid leukemia, aml, leukemia, refractory aml
