A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy — PEVENAZA

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:
A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

Status Active, not recruiting

Clinical Trial Summary

The main aim is to see how the combination of pevonedistat + venetoclax + azacitidine compares to venetoclax + azacitidine in adults recently diagnosed with AML who are unable to be treated with intensive chemotherapy. Participants will receive either pevonedistat + venetoclax + azacitidine or venetoclax + azacitidine in 28-day treatment cycles. Bone marrow samples (biopsy) will be collected throughout the study. Pevonedistat will be given as an intravenous (IV) infusion and Azacitidine will be given through IV or subcutaneous (under the skin). Study treatments may continue as long as the participant is receiving benefit from it. Participants may choose to stop treatment at any time.

Clinical Trial Description

The drug being tested in this study is called Pevonedistat. Pevonedistat is being tested to treat people who have AML. This study will compare the improvement in EFS in Arm A: Pevonedistat + Venetoclax + Azacitidine combination arm group when compared with Arm B: Venetoclax + Azacitidine. The study will enroll approximately 164 patients. Participants will be randomly assigned in 1:1 ratio to one of the two treatment groups in 28-day treatment cycles and which will remain disclosed to the patient and study doctor during the study: - Pevonedistat 20 mg/m^2 + Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400mg) + Azacitidine 75 mg/m^2 - Venetoclax 400 mg (ramp-up dose, Cycle 1 only: 100-400 mg) + Azacitidine 75 mg/m^2 This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 3 years. Participants will attend the end-of-treatment visit 30 days after the last dose of study drug or before the start of subsequent anti-neoplastic therapy if that occurs sooner. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04266795
Study type	Interventional
Source	Takeda
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	October 13, 2020
Completion date	June 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04240002` - A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)	Phase 1/Phase 2
Completed	`NCT02626715` - Reduced-Intensity Conditioning (RIC) and Myeloablative Conditioning (MAC) for HSCT in AML/MDS	Phase 2
Completed	`NCT05488613` - Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
Completed	`NCT02265731` - Study Evaluating Venetoclax in Subjects With Hematological Malignancies	Phase 1/Phase 2
Terminated	`NCT02927938` - Leukemia Stem Cell Detection in Acute Myeloid Leukemia	Phase 3
Completed	`NCT01772953` - Treosulfan/Fludarabine/Low Dose TBI as a Preparative Regimen for Children With AML/MDS Undergoing Allo HCT	Phase 2
Recruiting	`NCT03188874` - Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)
Completed	`NCT00071006` - AG-013736 (Axitinib) In Patients With Poor Prognosis Acute Myeloid Leukemia (AML) Or Myelodysplastic Syndrome (MDS)	Phase 2
Completed	`NCT04079296` - A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)	Phase 1/Phase 2
Completed	`NCT04509622` - A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)	Phase 3
Withdrawn	`NCT03699384` - Safety and Clinical Activity Study of Combination Azacitidine and Avelumab in Patients With Acute Myeloid Leukemia (AML) and Minimal Residual Disease (MRD)	Phase 1/Phase 2
Recruiting	`NCT03613532` - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN	Phase 1
Terminated	`NCT02259348` - Repeat Transplantation for Relapsed or Refractory Hematologic Malignancies Following Prior Transplantation	Phase 2
Completed	`NCT02252107` - 10-day Decitabine, Fludarabine and 2 Gray TBI as Conditioning Strategy for Poor and Very Poor Risk AML in CR1	Phase 2
Terminated	`NCT01463410` - Accuracy Testing of the Chromosomal Aberration and Gene Mutation Markers of the AMLProfiler	N/A
Completed	`NCT01242774` - Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML)	Phase 1
Terminated	`NCT02134782` - Yoga Fatigue Study	N/A
Completed	`NCT01685619` - AML-MDS Novel Prognostic Tests Clinical Study
Completed	`NCT03625505` - A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia	Phase 1
Recruiting	`NCT04446741` - Molecular Diagnostic Platform for AML