New drug combo offers hope for older AML patients who Can't tolerate chemo
NCT ID NCT04746235
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This study tests whether combining venetoclax with ASTX727 can help control acute myeloid leukemia (AML) in two groups: patients whose cancer returned or didn't respond to prior treatment, and older adults newly diagnosed who cannot handle strong chemotherapy. The drugs work together to block cancer cell growth. The goal is to see how many patients achieve remission and to monitor side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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85 people
The number who actually took part.
- Started
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Feb 2021
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with AML by the World Health Organization (WHO) classification who have failed prior therapy, refractory to it or relapsed after prior response. Patients with isolated extramedullary AML are eligible (cohort 1) * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * For cohort 2 (frontline elderly or unfit AML AML), the following inclusion criteria: * Confirmed newly diagnosed AML * Ineligible for induction therapy defined as * Either age \>= 75 years * Or 18-74 years of age with at least one comorbidity (chronic heart failure \[CHF\] requiring therapy or eject fraction \[EF\] =\< 50%, carbon monoxide diffusing capability \[DLCO\] =\< 65% or forced expiratory volume in 1 second \[FEV1\] =\< 65%, or ECOG 2 or 3) * Creatinine clearance ≥30 mL/min to \<45 mL/min * Moderate hepatic impairment with total bilirubin \>1.5 to ≤3.0 × upper limit of normal (ULN) * Creatinine clearance ≥ 45 ml/min unless related to the disease (e.g. infiltration) * Total bilirubin \< 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement * Alanine aminotransferase (ALT) \< 3 x ULN unless considered due to leukemic involvement (by biopsy or imaging) * Able to give written informed consent * Oral hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and hydroxyurea while the patient is on active study treatment through cycle 1, as needed, for clinical benefit and after discussion with the principal investigator (PI). Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted * Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment * Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment Exclusion Criteria: * Acute promyelocytic leukemia * Prior therapy with a BCL2 inhibitor * Symptomatic or uncontrolled CNS leukemia * Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III/IV, clinically significant and uncontrolled arrhythmia as judged by the treating physician * Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator * Pregnant or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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