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NCT Number: NCT05188326

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

61 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

A.O. SS. Antonio e Biagio e Cesare Arrigo, Alessandria, AL, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vidaza 100 milligram (mg) injection

Drug

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

Best supportive care

Other

Best supportive care includes antibiotics, transfusions and fluids

Primary outcomes

  1. Disease free Survival (DFS)

    Time frame: 5 years

    Disease-free survival (DFS) at 2 and 5 years. Events for DFS are death and first relapse (either AML or myelodysplastic syndrome (MDS) recurrence) and death; observations are censored at the date of last contact if alive and disease-free. DFS will be calculated from the date of achievement of CR to the date of 1st relapse or death. Patients still alive in 1st CR will be censored at the moment of last visit/contact.

Secondary outcomes

  1. Hospitalizations

    Time frame: 5 years

    Number and length of hospitalizations in the post-remission period.

  2. Overall Survival (OS)

    Time frame: 2 and 5 years

    Overall survival (OS) at 2 and 5 years. Event for OS in both arms is death and patients are censored at the date of last contact if alive

Sponsors and collaborators

Lead sponsor

Associazione Qol-one

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2021
Study completion
2021
First posted
Jan 12, 2022
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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