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DNA Methyltransferase Inhibitor
Combination Chemotherapy for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Tapan M Kadia
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ function: liver function (bilirubin < 2mg/dL, AST and/or ALT <3 x ULN), kidney function (creatinine < 1.5 x ULN), ECOG performance status of ≤ 2
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs as a potential treatment for acute myeloid leukemia.
Who is the study for?
This trial is for adults under 50 with untreated acute myeloid leukemia (AML), who can't have standard therapy. They must have normal liver and kidney function, be physically stable enough to participate, not pregnant or breastfeeding, willing to use contraception, and able to consent.Check my eligibility
What is being tested?
The study tests a combination of chemotherapy drugs: Venetoclax, Cladribine, low dose Cytarabine, and Azacitidine in two phases—induction followed by consolidation—to see if they're more effective together in treating AML.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea; risk of infection; fatigue; liver problems; decreased blood cell counts leading to bleeding or bruising risks. Specific reactions may vary based on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver and kidney functions are within normal limits and I can care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of complete response (CR/complete response with incomplete recovery [CRi])
Secondary outcome measures
Disease-free survival (DFS)
Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Overall response rate
+1 moreSide effects data
From 2022 Phase 3 trial • 389 Patients • NCT0200547133%
Neutropenia
11%
Abdominal pain
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
11%
Hypokalaemia
11%
Neutrophil count decreased
11%
Pneumonia
11%
Sepsis
11%
Anaemia
11%
Blood creatinine increased
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Dermatitis
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
COVID-19
11%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cladribine, cytarabine, venetoclax, azacitidine)Experimental Treatment4 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~1950
Cladribine
2014
Completed Phase 4
~4390
Cytarabine
2016
Completed Phase 3
~3310
Azacitidine
2012
Completed Phase 3
~1410
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,992 Previous Clinical Trials
1,792,510 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,118 Total Patients Enrolled
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