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

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

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 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
Neutrophil count decreased
11%
Blood creatinine increased
11%
Hypokalaemia
11%
Dermatitis
11%
Pneumonia pseudomonal
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Pneumonia
11%
Abdominal pain
11%
Anaemia
11%
Sepsis
11%
Gastroenteritis
11%
SARS-CoV-2 test positive
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
~1990
Cladribine
2014
Completed Phase 4
~4390
Cytarabine
2016
Completed Phase 3
~3310
Azacitidine
2012
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,176 Total Patients Enrolled
Tapan M KadiaPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,028 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the official stance of the FDA on Venetoclax?

"There is some clinical data supporting Venetoclax's safety, but none demonstrating its efficacy; it received a score of 2."

Answered by AI

Are people with the relevant health condition able to participate in this trial right now?

"Yes, this study is still looking for individuals to participate. The listing on clinicaltrials.gov shows that the trial was first posted on October 25th 2018 and edited September 19th 2020."

Answered by AI

Can you name a few other studies where Venetoclax has been used?

"Venetoclax is being investigated in 572 active clinical trials, the majority of which are in Phase 3. Although most of the research for Venetoclax is taking place in Edmonton, Alberta, there are 19891 total locations running clinical trials for this medication."

Answered by AI

For what ailments is Venetoclax commonly prescribed?

"Venetoclax has many potential applications, including the treatment of small lymphocytic lymphoma, malignant neoplasms, hairy cell leukemia, and multiple sclerosis."

Answered by AI

How many individuals are participating in this test?

"That is correct, the online clinicaltrials.gov registry currently lists this trial as recruiting patients. The listing includes the date when the study was first posted (10/25/2018) as well as the most recent edit (9/19/2022). This particular research project is only enrolling 85 participants at a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
2018. "Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03586609.
~22 spots leftby Apr 2025
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