A Randomized, Open Label Phase 3 Study Evaluating Safety and Efficacy of Venetoclax in combination with Azacitidine after allogeneic Stem Cell Transplantation in Subjects with Acute Myeloid Leukemia (AML) (VIALE-T)

Conditions

Acute Myeloid Leukaemia

Brief summary

Part I: The primary endpoint is the frequency of DLTs of venetoclax in combination with azacitidine, Part II: OS defined as the time from randomization to death from any cause

Detailed description

IRC-assessed morphologic RFS, IRC-assessed composite relapse-free survival, GvHD-free, relapse free survival (GRFS), GvHD rate at 90 days after randomization (Arm B) or initiation of treatment (Arm A). "Higher grade GvHD" is defined as Grade 2 or higher for aGvHD and moderate or severe for cGvHD as defined by the investigator following National Institutes of Health (NIH) criteria., Change from baseline (Cycle 1 Day 1 [predose]) at 6 months in physical functioning after randomization (Arm B) or initiation of study treatment (Arm A) in adult subjects, as measured by the EORTC QLQ-C30 physical functioning domain, Fatigue Change from baseline at 6 months after randomization (Arm B) or initiation of study treatment (Arm A) in adult subjects –defined as Fatigue measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a, Measurable residual disease conversion rate –The rate will be calculated only among subjects with MRD ≥10–3 at baseline (Cycle 1 Day 1 [predose]). The MRD conversion rate will be defined as proportion of subjects who convert to MRD < 10–3 after randomization (Arm B) or initiation of treatment (Arm A), Time to deterioration in Global Health Status (GHS)/QoL in adult subjects - defined as time from randomization to death from any cause, or the first-time deterioration of ≥10 points from baseline (Cycle 1 Day 1 [predose]) in GHS/QoL score as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Version 3, whichever occurs first

Related papers

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Interventions

DRUGAZACITIDINE

DRUGVenetoclax

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part I: The primary endpoint is the frequency of DLTs of venetoclax in combination with azacitidine, Part II: OS defined as the time from randomization to death from any cause	—

Secondary

Measure	Time frame
IRC-assessed morphologic RFS, IRC-assessed composite relapse-free survival, GvHD-free, relapse free survival (GRFS), GvHD rate at 90 days after randomization (Arm B) or initiation of treatment (Arm A). "Higher grade GvHD" is defined as Grade 2 or higher for aGvHD and moderate or severe for cGvHD as defined by the investigator following National Institutes of Health (NIH) criteria., Change from baseline (Cycle 1 Day 1 [predose]) at 6 months in physical functioning after randomization (Arm B) or initiation of study treatment (Arm A) in adult subjects, as measured by the EORTC QLQ-C30 physical functioning domain, Fatigue Change from baseline at 6 months after randomization (Arm B) or initiation of study treatment (Arm A) in adult subjects –defined as Fatigue measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a, Measurable residual disease conversion rate –The rate will be calculated only among subjects with	—

Measure

Time frame

IRC-assessed morphologic RFS, IRC-assessed composite relapse-free survival, GvHD-free, relapse free survival (GRFS), GvHD rate at 90 days after randomization (Arm B) or initiation of treatment (Arm A). "Higher grade GvHD" is defined as Grade 2 or higher for aGvHD and moderate or severe for cGvHD as defined by the investigator following National Institutes of Health (NIH) criteria., Change from baseline (Cycle 1 Day 1 [predose]) at 6 months in physical functioning after randomization (Arm B) or initiation of study treatment (Arm A) in adult subjects, as measured by the EORTC QLQ-C30 physical functioning domain, Fatigue Change from baseline at 6 months after randomization (Arm B) or initiation of study treatment (Arm A) in adult subjects –defined as Fatigue measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a, Measurable residual disease conversion rate –The rate will be calculated only among subjects with

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Countries

Czechia, France, Germany, Greece, Hungary, Italy, Spain

Outcome results

None listed