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Tests treatment safety and results for Acute Myeloid Leukemia
Official title A Phase Ia/Ib Open-label, Multiple Dose, Study to Determine the Recommended Dose, Evaluate PKs, PDs, Safety, and Activity of Venetoclax in Combination With Oral Decitabine/Cedazuridine (ASTX727) in Pediatric Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT06191978
What this study is testing
What is ASTX727?
ASTX727 is an investigational medicine, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as Inqovi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To find a recommended dose of ASTX727 (cedazuridine/decitabine) in combination with venetoclax for pediatric patients with relapsed AML.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- Pediatric Participants with Relapsed/refractory AML by WHO criteria.
- Participants must have ≥ 5% blasts in the bone marrow as assessed by morphology or flow cytometry. However, if an adequate bone marrow sample cannot...
- Performance status: Lansky ≥ 50 for participants who are ≤ 16 years old and Karnofsky ≥ 50% for participants who are \> 16 years old.
- Age ≥2 years of age and ≤18 years of age
- Able to swallow pills
You likely can't join if
- Concomitant other anti-cancer therapy and/or participation in any other investigational clinical trials except for hydroxyurea. Concurrent...
- History of another primary invasive malignancy that has not been definitively treated and is in remission. Participants with non-melanoma skin...
- Presence of clinically significant uncontrolled central nervous system (CNS) pathology such as epilepsy, childhood seizure, paresis, aphasia, stroke...
- Evidence of active cerebral/meningeal disease. Participants may have history of CNS leukemic involvement if definitively treated with prior therapy...
- Participants with uncontrolled, active infections (viral, bacterial, or fungal) or other disease expected to interfere with the ability of the PI to...
- Known active hepatitis B (eg, HBsAg reactive), or hepatitis C (eg, HCV RNA [qualitative] is detected), or chronic hepatitis B or C infection or human...
See the full eligibility criteria
- Pediatric Participants with Relapsed/refractory AML by WHO criteria.
- Participants must have ≥ 5% blasts in the bone marrow as assessed by morphology or flow cytometry. However, if an adequate bone marrow sample cannot be obtained, participants may be enrolled if there is unequivocal...
- Performance status: Lansky ≥ 50 for participants who are ≤ 16 years old and Karnofsky ≥ 50% for participants who are \> 16 years old.
- Age ≥2 years of age and ≤18 years of age
- Able to swallow pills
- The following baseline laboratory data:
- Total serum bilirubin ≤1.5 x upper limit of normal (ULN) for age, unless the increased value is likely attributed to disease involvement. Participants with known Gilbert's syndrome may have a total bilirubin up to ≤5 x...
- Creatinine clearance (Schwartz-Formula) or radioisotope GFR ≥ 60ml/min/1.73 m2 or a serum creatinine based on age/sex as follows:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤3 x ULN; ≤5 x ULN in case of suspected leukemic liver involvement.
- Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use one of...
- At least one parents or LAR must provide signature of informed consent and there must be documentation of assent by the subject, as age appropriate, before completing any study-related procedures.
- Concomitant other anti-cancer therapy and/or participation in any other investigational clinical trials except for hydroxyurea. Concurrent hydroxyurea use should be limited to the first 2 cycles of therapy only.
- History of another primary invasive malignancy that has not been definitively treated and is in remission. Participants with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from...
- Presence of clinically significant uncontrolled central nervous system (CNS) pathology such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, organic brain syndrome, or psychosis.
- Evidence of active cerebral/meningeal disease. Participants may have history of CNS leukemic involvement if definitively treated with prior therapy and no evidence of active disease at the time of consent with at least...
- Participants with uncontrolled, active infections (viral, bacterial, or fungal) or other disease expected to interfere with the ability of the PI to assess the how well it works of the study drug. Infections controlled...
- Known active hepatitis B (eg, HBsAg reactive), or hepatitis C (eg, HCV RNA [qualitative] is detected), or chronic hepatitis B or C infection or human immunodeficiency virus (HIV) infection in medical history (historical...
- Liver cirrhosis or other serious active liver disease or with suspected active alcohol abuse.
- Exclude participants with active GVHD and those on immunosuppressive drugs for treatment of GVHD. Require that participants be off calcineurin inhibitors for at least 4 weeks to be eligible.
- Prior chemotherapy/radiotherapy/investigational therapy within 2 weeks before the start of study drugs with the following exception: a. To reduce the circulating blast count or palliation: intravenous cytarabine...
- Females who are pregnant or lactating.
- Male or female people of childbearing potential, unwilling to use an approved, effective means of contraception.
- Other severe, uncontrolled acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the Investigator may increase the risk associated with study participation or investigational...
- Participants with acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible.
- Known or suspected hypersensitivity to decitabine, cedazuridine, or venetoclax.
- Participants on concomitant medications known to be metabolized by CDA will need review of the medication and assessment of possible impact of avoiding dosing during the 24 hours prior to possible enrollment, at the...
- Participants of adult age (= 18 years of age) who are cognitively impaired will not be eligible for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.