This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)
Thanks to recent advantages and results that demonstrate that low-intensity rescues may be quantitatively comparable to chemotherapy, novel personalized therapies are being slowly integrated into the treatment options of R/R AML. These new strategies, for the high interpatient variability, for the different cross-country reimbursement, for the school of thinking of treatment physicians, will wait decades to be proficiently compared with standard chemotherapy in the R/R setting, especially because most of the novel drugs are being pushed by the companies in the front-line (a setting that still has a large room for improvements). In IMPACT-AML RPCT, low-intensity therapies will be compared with high intensity chemotherapy rescue following a pragmatic, clinical-oriented approach. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
339
* High and intermediate dose Cytarabine * Mitoxantrone - Etoposide - Cytarabine (MEC) * fludarabine - cytarabine - idarubicin - G-CSF (FLAG-IDA) * cladribine - high dose cytarabine (2CDA+HDAraC) * mitoxantrone - intermediate dose cytarabine (MiDAC) * fludarabine - amsacrine - cytarabine (FLAMSA) * Mitoxantrone - Intermediate-dose Cytarabine (HAM) * 3+7 (cytarabine and daunorubicine or idarubicine)
* Venetoclax+hypomethylating agent (decitabine, azacitidine) * Venetoclax+low dose cytarabine * Gilteritinib alone or in combination with low dose hypomethylating agent or low dose cytarabine * 2CDA 5mg/sqm + low dose cytarabine * Glasdegib+low dose cytarabine * Ivosidenib alone or in combination with low dose hypomethylating agent or low dose cytarabine * Single agent Gemtuzumab or Gemtuzumab in combination with alone or in combination with low dose hypomethylating agent or low dose cytarabine
University Hospital Brno
Brno, Czechia
RECRUITINGUniversity Hospital Hradec Králové
Hradec Králové, Czechia
NOT_YET_RECRUITINGUniversity Hospital Olomouc
Olomouc, Czechia
NOT_YET_RECRUITINGUniversity Hospital in Ostrava
Ostrava, Czechia
NOT_YET_RECRUITINGTo determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy.
Event-free survival defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first.
Time frame: 36 months
To determine if low intensity therapy improves overall survival
Overall survival, defined as time from randomization to the date of death from any cause.
Time frame: 36 months
To determine if low intensity therapy improves the overall response (Complete response (CR)/CR with partial hematologic recovery(CRh)/CR with incomplete hematologic recovery(CRi),morphologic leukemia-free state(MLFS))
Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort.
Time frame: 36 months
To determine if low intensity therapy improves patients-reported quality of life
Change in Hematologic Malignancy-Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment.
Time frame: 36 months
To evaluate the safety of low intensity therapies as compared to high intensity therapies
Proportion of patients experiencing adverse events.
Time frame: 36 months
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University Hospital in Pilsen
Pilsen, Czechia
NOT_YET_RECRUITINGUniklinik RWTH Aachen
Aachen, Germany
RECRUITINGUniversity Hospital Greifswald
Greifswald, Germany
RECRUITINGKrankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany
NOT_YET_RECRUITINGUniversity Hospital Halle
Halle, Germany
RECRUITINGUniversity Hospital of Rostock
Rostock, Germany
RECRUITING...and 37 more locations