NCT06713837

IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 339 (estimated)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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)

Conditions

• Acute Myeloid Leukemia
• Relapse/Recurrence

Interventions

Type	Name	Description
DRUG	High intensity therapies	* 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)
DRUG	Low intensity therapies	* 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

Timeline

• Start date: 2025-02-27
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2024-12-03
• Last updated: 2026-04-08

Locations

47 sites across 7 countries: Czechia, Germany, Italy, Lithuania, Portugal, Romania, Spain