Trial | NCT05188326  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    54
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.
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
Study Started
Nov 28
2010
Primary Completion
Sep 27
2021
Study Completion
Sep 27
2021
Last Update
Jun 08
2023

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 names: Vidaza

Other Best Supportive Care

Best supportive care includes antibiotics, transfusions and fluids

Azacitidine Experimental

Vidaza consists of 50 mg/ m2 s.c or i.v for 7 days (5 + weekend off + 2) every 28 days and increase after 1st cycle, if well tolerated, to 75 mg/m2 s.c or i.v. for 7 days (5 + weekend off + 2) every 28 days for further 5 cycles followed by cycles every 56 days for 4 years and six months

Best supportive care Placebo Comparator

No drug administration

Criteria 

Inclusion Criteria:

Age 61 years or more
Newly diagnosed AML with > 30% myeloid marrow blasts, either "de novo" or evolving from a MDS not previously treated with chemotherapeutic agents.
Absence of central nervous system involvement

No contraindications for intensive chemotherapy, defined as:

prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
a creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
a Performance Status (PS) score of > 2;
uncontrolled severe infection.
Informed consent.

Exclusion Criteria:

Age ≤ 60 years
Newly diagnosed AML with < 30% myeloid marrow blasts
Previously treated AML
Central nervous system involvement
Prior congestive heart failure requiring treatment and/or left ventricular systolic ejection fraction below the normal range;
A creatinine or bilirubin level more than twice the upper limit of normal, except if AML-related;
A PS score of > 2;
Uncontrolled severe infection.
No Results Posted