Status:
ACTIVE_NOT_RECRUITING
Venetoclax and ASTX727 for the Treatment of Relapsed, Refractory, or Newly Diagnosed Acute Myeloid Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies the possible benefits of venetoclax and ASTX727 in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory)...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) of decitabine and cedazuridine (ASTX727) in combination with venetoclax in patients with refractory/relapsed acute myeloid leukemia...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2026
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04746235
Start Date
February 22 2021
End Date
October 31 2026
Last Update
October 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030