Clinical Trials Logo

Clinical Trial Summary

This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To assess the efficacy (complete remission [CR], complete remission without blood count recovery [CRi], complete remission without platelet recovery [CRp]) of liposome-encapsulated daunorubicin-cytarabine (CPX-351) in combination with venetoclax in patients with acute myeloid leukemia (AML). SECONDARY OBJECTIVES: I. To assess safety of CPX-351 in combination with venetoclax in patients with AML. II. To assess the event free survival (EFS) and overall survival (OS) in patients with AML. EXPLORATORY OBJECTIVE: I. To explore biomarkers of response and resistance in AML treated with CPX-351 and venetoclax. OUTLINE: This is a dose-escalation study of venetoclax. INDUCTION: Participants receive liposome-encapsulated daunorubicin-cytarabine intravenously (IV) over 90 minutes on days 1, 3, and 5 of cycle 1 and on days 1 and 3 of cycle 2. Participants also receive venetoclax orally (PO) once daily (QD) on days 2-21. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Participants receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3 and venetoclax PO QD on days 2-21. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days and then every 3 months for 3 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03629171
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Tapan Kadia
Phone 713-563-3534
Email tkadia@mdanderson.org
Status Recruiting
Phase Phase 2
Start date October 29, 2018
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02890329 - Ipilimumab and Decitabine in Treating Patients With Relapsed or Refractory Myelodysplastic Syndrome or Acute Myeloid Leukemia Phase 1
Active, not recruiting NCT04975919 - Venetoclax in Combination With Decitabine and Cedazuridine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Phase 2
Terminated NCT02882321 - Oxidative Phosphorylation Inhibitor IACS-010759 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 1
Recruiting NCT03214562 - Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Active, not recruiting NCT03289910 - Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia Phase 2
Completed NCT02756572 - Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms Phase 2
Completed NCT02509546 - 8-Chloroadenosine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Recruiting NCT03683433 - Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation Phase 2
Completed NCT02551718 - High Throughput Drug Sensitivity Assay and Genomics- Guided Treatment of Patients With Relapsed or Refractory Acute Leukemia N/A
Completed NCT02070458 - Ixazomib, Mitoxantrone Hydrochloride, Etoposide, and Intermediate-Dose Cytarabine in Relapsed or Refractory Acute Myeloid Leukemia Phase 1
Terminated NCT03557970 - JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia Phase 2
Recruiting NCT03661307 - Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome Phase 1/Phase 2
Recruiting NCT05396859 - Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia Phase 1
Terminated NCT03067571 - Daratumumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Phase 2
Completed NCT04146038 - Salsalate, Venetoclax, and Decitabine or Azacitidine for the Treatment of Acute Myeloid Leukemia or Advanced Myelodysplasia/Myeloproliferative Disease Phase 2
Suspended NCT03128034 - 211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia Phase 1/Phase 2
Active, not recruiting NCT04207190 - Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia Phase 1
Recruiting NCT04047641 - Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome Phase 1/Phase 2
Withdrawn NCT04493099 - Alvocidib in Combination With Decitabine and Venetoclax in Patients With Relapsed or Refractory AML or as Frontline Therapy in Unfit Patients With AML Phase 1/Phase 2
Withdrawn NCT03291353 - Phase 0- Pilot Study of Pembrolizumab on Immune Cells in Patient With Refractory Acute Myeloid Leukemia Early Phase 1