NCT05188326

Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia (AML) in Elderly Patients

A Randomized Study to Evaluate the Efficacy of 5-Aza for Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Associazione Qol-one · Academic / Other
• Sex: All
• Age: 61 Years
• Healthy volunteers: Not accepted

Summary

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved complete remission (CR) following conventional induction ('3+7') and consolidation chemotherapy.

Detailed description

The present study aims to compare the efficacy of postremission maintenance therapy with 5-Aza versus best supportive care (BSC) in a cohort of AML patients aged \>60 years, who have achieved CR following conventional induction ('3+7') and consolidation chemotherapy to evaluate 2 an 5 year post-remission rates of Overall Survival and disease free survival between two arms

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Vidaza 100 milligram (mg) injection	1st cycle 50 mg/sqm s.c. or i.v. for 7 days (5 + weekend off + 2) every 28 days and increase dosing after 1st cycle, if well tolerated, to 75 mg/ m2 for further 5 cycles, followed by cycles every 56 days for 4 years and six months post-remission.
OTHER	Best Supportive Care	Best supportive care includes antibiotics, transfusions and fluids

Timeline

• Start date: 2010-11-28
• Primary completion: 2021-09-27
• Completion: 2021-09-27
• First posted: 2022-01-12
• Last updated: 2023-06-08

Locations

18 sites across 1 country: Italy