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DNA Methyltransferase Inhibitor

Venetoclax + Decitabine for Acute Myeloid Leukemia

Phase 2

Waitlist Available

Led By Marina Konopleva

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

Patients with AML, BPDCN, biphenotypic or bilineage leukemia (including a myeloid component) or mixed phenotype acute leukemia (MPAL) who have failed prior therapy; patients with AML should have failed prior therapy or have relapsed after prior therapy; patients with isolated extramedullary AML are eligible

Patients with newly diagnosed AML with poor risk complex karyotype and/or TP53 deletions/mutations equal or younger than 60 year old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying venetoclax and decitabine to see how well they work in treating acute myeloid leukemia and high-risk myelodysplastic syndrome.

Who is the study for?

This trial is for adults under 60 with newly diagnosed AML or high-risk MDS, not responding to treatment or relapsed. Participants must have adequate liver and kidney function, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have certain blood cancers (like acute promyelocytic leukemia) or uncontrolled medical conditions.Check my eligibility

What is being tested?

The study tests how well venetoclax combined with decitabine works in treating relapsed/refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). It's a phase II trial focusing on the effectiveness of these chemotherapy drugs in stopping cancer cell growth.See study design

What are the potential side effects?

Venetoclax and decitabine can cause side effects like low blood cell counts leading to increased infection risk, bleeding problems, fatigue, nausea, vomiting, diarrhea. Liver function may also be affected. The severity of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a specific type of leukemia and previous treatments didn't work or my cancer returned.

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I am 60 or younger with a specific type of aggressive AML.

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My kidney function is normal, with creatinine levels below 2.

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I have high-risk MDS or CMML, failed or relapsed after HMA therapy.

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I may receive specific treatments for my rapidly growing cancer before and during the study, as approved by the study leader.

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I am over 60 and have a certain type of leukemia but can't undergo strong chemotherapy.

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I am not able to have children, am postmenopausal, or have a negative pregnancy test.

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I was diagnosed with AML after having MDS or CMML, regardless of previous treatments.

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I am capable of limited self-care and spend less than half of my day in bed or sitting.

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My liver is functioning well, with normal bilirubin levels.

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I agree to use birth control during and for 3 months after the study ends.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Overall response rate (ORR)

Secondary outcome measures

Disease free survival

Duration of response

Incidence of adverse events

+1 more

Other outcome measures

Biomarker analysis

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%

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 (decitabine, venetoclax)Experimental Treatment3 Interventions

Participants receive decitabine IV over 1 hour on days 1-10 and may also receive decitabine on days 1-5 after achieving complete remission/complete remission with incomplete count recovery during consolidation/maintenance. Participants also receive venetoclax PO daily on days 1-28 of cycle 1 and on days 1-21 of subsequent cycles. Treatment repeat every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

Decitabine

2004

Completed Phase 3

~1680

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,406 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,971 Previous Clinical Trials

1,787,002 Total Patients Enrolled

Marina KonoplevaPrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

37 Total Patients Enrolled

Media Library

Decitabine (DNA Methyltransferase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03404193 — Phase 2

Acute Myeloid Leukemia Research Study Groups: Treatment (decitabine, venetoclax)

Acute Myeloid Leukemia Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT03404193 — Phase 2

Decitabine (DNA Methyltransferase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03404193 — Phase 2

Frequently Asked Questions

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

What medical indications is Venetoclax commonly utilized to treat?

"Venetoclax is used to treat refractory anemia, as well as chronic lymphocytic leukemia (CLL), and IPSS risk categories of intermediate-1 and intermediate-2."

Answered by AI

Has Venetoclax been given the green-light from the FDA?

"Venetoclax has been clinically assessed to have a safety rating of 2 due to the lack of data supporting efficacy, despite Phase 2 trials having validated its security."

Answered by AI

Are there any other experiments using Venetoclax that have been conducted prior to this one?

"At this time, 302 Venetoclax trials have been launched; 42 of them are in their final stage. The primary hub for these studies is Edmonton, Alberta though there are 8576 sites running tests with the drug worldwide."

Answered by AI

Are there any remaining opportunities to partake in this research?

"Affirmative. Data on clinicaltrials.gov confirms that this research endeavour, which was first published on January 18th 2018, is currently recruiting. Approximately 400 volunteers must be recruited from 1 distinct medical site."

Answered by AI

What is the scope of participants in this research endeavor?

"Affirmative. Clinicaltrials.gov states that this trial, which debuted on January 18th 2018 and was recently renewed October 24th 2022, is recruiting for 400 participants from one centre."

Answered by AI

Recent research and studies

The Lancet HaematologyJournal

10-day Decitabine with Venetoclax for Newly Diagnosed Intensive Chemotherapy Ineligible, and Relapsed or Refractory Acute Myeloid Leukaemia: A Single-centre, Phase 2 Trial

DiNardo, Courtney D, Abhishek Maiti, Caitlin R Rausch, Naveen Pemmaraju, Kiran Naqvi, Naval G Daver, Tapan M Kadia, et al.. 2020. “10-day Decitabine with Venetoclax for Newly Diagnosed Intensive Chemotherapy Ineligible, and Relapsed or Refractory Acute Myeloid Leukaemia: A Single-centre, Phase 2 Trial”. The Lancet Haematology. Elsevier BV. doi:10.1016/s2352-3026(20)30210-6.

tp53Journal

Outcomes of <i>tp53</i> ‐mutant Acute Myeloid Leukemia with Decitabine and Venetoclax

Kim, Kunhwa, Abhishek Maiti, Sanam Loghavi, Rasoul Pourebrahim, Tapan M. Kadia, Caitlin R. Rausch, Ken Furudate, et al.. 2021. “Outcomes of tp53 ‐mutant Acute Myeloid Leukemia with Decitabine and Venetoclax”. Cancer. Wiley. doi:10.1002/cncr.33689.

<scp>idh1/2</scp> ‐ Journal

Decitabine and Venetoclax for <i> <scp>idh1/2</scp> ‐ </i> Mutated Acute Myeloid Leukemia

Venugopal, Sangeetha, Abhishek Maiti, Courtney D. DiNardo, Sanam Loghavi, Naval G. Daver, Tapan M. Kadia, Caitlin R. Rausch, et al.. 2021. “Decitabine and Venetoclax for idh1/2 ‐ Mutated Acute Myeloid Leukemia”. American Journal of Hematology. Wiley. doi:10.1002/ajh.26122.

Blood AdvancesJournal