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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
Must not have
Men and women of childbearing potential who do not practice contraception
Participants with a diagnosis of acute promyelocytic leukemia (AML-M3)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My liver and kidney functions are within normal limits and I can care for myself.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am of childbearing age and do not use birth control.
Select...
I have been diagnosed with acute promyelocytic leukemia.
Select...
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
Select...
I have been treated with venetoclax before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Rate of complete response (CR/complete response with incomplete recovery [CRi])
Secondary study objectives
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 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2240
Cladribine
2014
Completed Phase 4
~4410
Cytarabine
2016
Completed Phase 3
~3330
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,067 Previous Clinical Trials
1,802,501 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,125 Total Patients Enrolled
~9 spots leftby Apr 2025
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