Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical research study is find the highest tolerable dose of venetoclax that can be given in combination with a type of chemotherapy called FLAG-IDA to patients with acute myeloid leukemia (AML). FLAG-IDA chemotherapy includes fludarabine, cytarabine, idarubicin, and filgrastim.

The safety of this drug combination will also be studied.

This is an investigational study. FLAG-IDA chemotherapy is FDA approved and commercially available for the treatment of AML. Venetoclax is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia. It is considered investigational to use venetoclax to treat AML. The study doctor can explain how the study drugs are designed to work.

Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03214562
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Courtney DiNardo, MD
Phone 713-794-1141
Email cdinardo@mdanderson.org
Status Recruiting
Phase Phase 1/Phase 2
Start date September 26, 2017
Completion date September 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03197714 - Clinical Trial of OPB-111077 in Patients With Relapsed or Refractory Acute Myeloid Leukaemia Phase 1
Recruiting NCT03224819 - Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia Early Phase 1
Recruiting NCT03665480 - The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML Phase 2/Phase 3
Active, not recruiting NCT02485535 - Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant Phase 1
Recruiting NCT02882321 - Study of IACS-010759 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML) Phase 1
Recruiting NCT02771197 - Lymphodepletion and Anti-PD-1 Blockade to Reduce Relapse in AML Patient Not Eligible for Transplant Phase 2
Recruiting NCT02933333 - G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor Phase 4
Recruiting NCT03298984 - Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML). Phase 1
Recruiting NCT03256071 - Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT Phase 2/Phase 3
Recruiting NCT02975869 - A Collaborative Palliative and Oncology Care Model for Patients With Acute Myeloid Leukemia N/A
Recruiting NCT02909972 - Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome Phase 1
Recruiting NCT02668653 - Quizartinib With Standard of Care Chemotherapy and as Maintenance Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) Phase 3
Active, not recruiting NCT02899286 - Efficacy and Safety Study of Recombinant Human Arginase 1 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 2
Recruiting NCT02229266 - Randomised Controlled Phase-2 Trial to Determine the Efficacy of Adoptive Immunotherapy With NK Cells in High-risk AML Phase 2
Recruiting NCT02483312 - A Study of (Interleukin-12) IL-12 in Patients With Acute Myelogenous Leukemia (AML) Phase 1
Recruiting NCT02400255 - Crenolanib Maintenance Following Allogeneic Stem Cell Transplantation in FLT3-positive Acute Myeloid Leukemia Patients Phase 2
Recruiting NCT02502968 - BL-8040 Addition to Consolidation Therapy in AML Patients Phase 2
Recruiting NCT02543879 - Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies Phase 1
Active, not recruiting NCT02400281 - Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients Phase 1/Phase 2
Completed NCT02544438 - Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Phase 1/Phase 2