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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have a specific type of leukemia (Ph+ AML, AP-CML, or BP-CML).
Select...
I can take care of myself but can't do heavy physical work.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Proportion of patients proceeding to allogeneic stem cell transplant
+2 more
Other outcome measures
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-

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
2004
Completed Phase 3
~1680
Ponatinib
2015
Completed Phase 2
~820
Venetoclax
2019
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,478 Total Patients Enrolled
Nicholas ShortPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
156 Total Patients Enrolled

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04188405 — Phase 2
Chronic Myelogenous Leukemia Research Study Groups: Treatment (ponatinib, venetoclax, decitabine)
Chronic Myelogenous 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

Frequently Asked Questions

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

Has there been any further research done with Ponatinib outside of this trial?

"As of today, Ponatinib has been subject to 328 clinical studies with 45 of those trials currently in the third phase. Of these investigations, Toronto is the primary location however there are more than 9000 other sites participating research for this medication."

Answered by AI

Are there any open opportunities to join this investigation?

"According to the details provided on clinicaltrials.gov, this medical investigation is actively soliciting participants for enrollment. The research was initially posted in May 2020 and recently modified in October 2022."

Answered by AI

What is the general purpose of Ponatinib administration?

"Ponatinib is generally prescribed to patients with intermediate-2 IPSS risk scores. Furthermore, it has been effectively used in the treatment of refractory anemias, blast phase chronic myelocytic leukemia, and muscular dystrophy."

Answered by AI

How many participants are involved in this trial?

"Affirmative. According to information found on clinicaltrials.gov, this research project is actively enrolling patients and was initially publicized on May 17th 2020 with an edit made as recently as October 31st 2022. The investigators are looking for 30 individuals from a single site to participate in the study."

Answered by AI

To what extent does Ponatinib potentially pose a risk to individuals?

"Due to the limited clinical evidence in favor of Ponatinib's efficacy, our team at Power gave this medication a score of 2 on its safety rating scale."

Answered by AI
~2 spots leftby Sep 2024