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Anti-metabolites

Triple Drug Therapy for Leukemia

Phase 2
Waitlist Available
Led By Nicholas Short
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 Philadelphia (Ph)+ acute myeloid leukemia (AML) or myeloid accelerated phase (AP)-chronic myelogenous leukemia (CML) or blast phase (BP)-CML (either t[9;22] and/or BCR-ABL1 positive by fluorescent in situ hybridization or polymerase chain reaction). Both untreated and relapsed/refractory patients are eligible
Performance status =< 3 (Eastern Cooperative Oncology Group [ECOG] scale)
Must not have
Diagnosed or suspected congenital long QT syndrome
Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a combination of 3 drugs to treat leukemia. Decitabine and venetoclax work in different ways to stop the growth of cancer cells, and ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Who is the study for?
This trial is for adults with Philadelphia chromosome-positive acute myeloid leukemia or chronic myelogenous leukemia in blast or accelerated phase. Participants must be able to perform daily activities (ECOG <=3), have adequate organ function, and be able to swallow pills. Pregnant women are excluded, and participants must agree to use contraception.
What is being tested?
The study tests a combination of three drugs: Decitabine, Venetoclax, and Ponatinib. It aims to see how well they work together in stopping cancer cell growth by killing the cells or preventing them from dividing and spreading.
What are the potential side effects?
Potential side effects may include infection risks due to weakened immune system, liver issues reflected by blood test changes, digestive problems like nausea or constipation, fatigue, possible heart complications such as arrhythmias or heart failure symptoms.

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 (Ph+ AML, AP-CML, or BP-CML).
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I can take care of myself but can't do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or might have long QT syndrome.
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I do not have an uncontrolled serious infection.
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I have had acute pancreatitis in the last 6 months or suffer from chronic pancreatitis.
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I do not have severe heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4.5 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
Overall response rate
Secondary study objectives
Incidence of adverse events
Overall survival (OS)
Proportion of patients proceeding to allogeneic stem cell transplant
+2 more
Other study objectives
Apoptotic protein expression and Bcl-2 dependency on response and resistance

Side effects data

From 2017 Phase 2 trial • 171 Patients • NCT01935336
67%
Grade 2 hypertension
67%
Grade 3 AE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ponatinib SISH-/ISH+
Ponatinib SISH-/ISH-
Ponatinib SISH+/ISH+
Ponatinib SISH+/ISH-

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 (ponatinib, venetoclax, decitabine)Experimental Treatment3 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decitabine
2011
Completed Phase 3
~2370
Ponatinib
2015
Completed Phase 2
~830
Venetoclax
2019
Completed Phase 3
~2240

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,317 Total Patients Enrolled
Nicholas ShortPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
162 Total Patients Enrolled

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04188405 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (ponatinib, venetoclax, decitabine)
Acute Myeloid Leukemia Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT04188405 — Phase 2
Decitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04188405 — Phase 2
~4 spots leftby Sep 2025
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