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Anti-metabolites

Decitabine + Lisaftoclax + Olverembatinib for Leukemia

Phase 1

Recruiting

Led By Nicholas Short, MD

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 renal function: Creatinine clearance ≥30 mL/min

Participants must have been intolerant or resistant to at least one prior BCR::ABL1 TKI

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to Decitabine, Lisaftoclax, and Olverembatinib or other agents used in study

Participants who have previously received lisaftoclax or olverembatinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine the safe and effective doses of two medications, lisaftoclax and olverembatinib, that can be used together with decitabine in patients with advanced

Who is the study for?

This trial is for adults with advanced chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute myeloid leukemia (Ph+ AML). Participants should not have had previous treatments that failed. Specific health conditions and medications may exclude some individuals.

What is being tested?

The study aims to determine the safe doses of lisaftoclax and olverembatinib when used together with decitabine in patients with advanced CML or Ph+ AML. It's an early-phase trial, meaning it's mostly about safety and finding the right dose.

What are the potential side effects?

Possible side effects from these drugs might include fatigue, nausea, low blood cell counts leading to increased infection risk, bleeding problems, liver issues, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My kidneys are working well enough (creatinine clearance ≥30 mL/min).

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I have had a bad reaction or no response to a previous BCR-ABL1 TKI treatment.

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I can care for myself but may not be able to do any physical work.

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I am 18 or older with a specific type of leukemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have no allergies to Decitabine, Lisaftoclax, Olverembatinib, or similar drugs.

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I have previously taken lisaftoclax or olverembatinib.

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I have not taken strong CYP3A or p-glycoprotein inducers in the last 14 days.

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I cannot swallow.

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I have leukemia that has spread to my brain.

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I have a serious infection that isn't getting better with antibiotics.

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I have had pancreatitis within the last year or suffer from chronic pancreatitis.

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I do not have severe heart failure.

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I do not have serious heart or blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment3 Interventions

Participants enrolled in Phase II, participants will receive lisaftoclax at the recommended dose that was found in Phase I

Group II: Phase 1Experimental Treatment3 Interventions

Participants enrolled in Phase I, the dose of lisaftoclax you receive will depend on when a participants join this study. Up to 2 dose levels of lisaftoclax will be tested. Between 3-12 participants will be enrolled at each dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Decitabine

2011

Completed Phase 3

~2370

0 / 13Eligibility criteria met