Actively Recruiting
Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-02-24
32
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
Q
Qurient Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn about the safety and tolerability of the drug combination of Q702, azacitidine, and venetoclax when given to participants with relapsed/refractory AML.
CONDITIONS
Official Title
Phase I Study of Q702 With Azacitidine and Venetoclax for Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of AML or MDS/AML with 10% to 19% blasts according to 2022 classifications
- Age 18 years or older with relapsed or refractory AML or MDS/AML, excluding acute promyelocytic leukemia, without standard treatment options
- Relapsed or refractory disease as defined by specific criteria including prior treatments and remission duration
- ECOG performance status 0 to 1
- Patients relapsing after allogeneic stem cell transplant must have recovered from transplant toxicities and be off immunosuppression except possibly low-dose steroids
- Patients with actionable mutations may be enrolled after exhausting FDA-approved therapies
- Patients with antecedent hematological disorders progressing to AML are eligible for certain cohorts
- Adequate liver function with total bilirubin ≤1.5 times upper limit normal (except Gilbert disease allowed up to 4.5 mg/dL) and AST/ALT ≤2 times upper limit normal
- Adequate kidney function with creatinine clearance >60 mL/min
- Agreement to use effective contraception during and after the study for women of childbearing potential and men
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of t(15;17) chromosomal abnormality
- White blood cell count greater than 15 x 10^9/L (temporary medications allowed to meet this criterion)
- Use of cytotoxic chemotherapy, targeted therapy, radiotherapy, immunotherapy, or other clinical trial treatments within 2 weeks before study start
- Known symptomatic or uncontrolled central nervous system leukemia
- Active systemic infections not improving with treatment
- Active eye disorders that may increase risk of drug-related eye damage, except mild vision issues approved by an ophthalmologist
- Known active neurological disorders requiring treatment or causing residual deficits
- Known acute or chronic liver disease with elevated liver tests
- Uncontrolled serious heart or lung conditions
- History of certain heart rhythm problems or prolonged QT interval
- Severe gastrointestinal or metabolic conditions interfering with drug absorption
- Active hepatitis B, hepatitis C, HIV, or HTLV-1 infection
- Other medical, psychological, or social conditions that may interfere with participation or safety
- Previous cancers unless fully treated and healed as specified
- Recent major surgery or unhealed major wounds
- Legal guardianship or uncontrolled psychiatric conditions impairing compliance
- Allergies to study drugs or their components
- Nursing women or women who are pregnant or unwilling to use contraception
- Pregnant women due to potential risks to fetus and nursing infants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Abhishek Maiti, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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