Recruiting NCT06372717
A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: APL-4098, Azacitidine and APL-4098, Azacitidine and Venetoclax and APL-4098.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia Refractory, Myelodysplastic Syndrome Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts, Acute Myeloid Leukemia, in Relapse. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome/AML (MDS/AML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)
Overview
This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)/AML and MDS-excess blasts (EB).
Interventions
- Drug APL-4098
APL-4098 is administered orally in 28-day cycles - Drug Azacitidine and APL-4098
Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; APL-4098 is administered orally. - Drug Azacitidine and Venetoclax and APL-4098
Azacitidine is administered at the standard dose on Day 1 - Day 7 of each 28-day cycle; Venetoclax is administered orally; APL-4098 is administered orally.
Primary outcome measures
- Incidence of Treatment Emergent Adverse Events [Safety] [Time frame: Through study completion, approximately one year]
- Incidence of Dose Limiting Toxicities [Tolerability] [Time frame: Cycle 1 Day 1 to Cycle 2 Day 1 (a cycle is 28 days)]
- Determine Recommended Phase 2 Dose (RP2D)/Recommended dose range (RDR) levels of APL-4098 alone, in combination with azacitidine, and in combination with azacitidine plus venetoclax. [Time frame: Approximately one year]
- Assess the Pharmacokinetics of APL-4098 [Time frame: On Days 1, 2, 8, and 15 of Cycle 1, and on Day 1 of Cycle 2 (each cycle is 28 days)]
- Assess the Pharmacokinetics of APL-4098 [Time frame: On Days 1, 2, 8, and 15 of Cycle 1, and on Day 1 of Cycle 2 (each cycle is 28 days)]
- Assess the Pharmacokinetics of APL-4098 [Time frame: On Days 1, 2, 8, and 15 of Cycle 1, and on Day 1 of Cycle 2 (each cycle is 28 days)]
Secondary outcome measures (1)
- Assess response to disease with APL-4098 alone, in combination with azacitidine, and in combination with azacitidine plus venetoclax. [Time frame: Response is assessed at Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 (each cycle is 28 days long), then every three cycles thereafter (assessed for up to 2 years)]
Eligibility criteria
Inclusion criteria
- 18 years or older
- Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS)/ AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R/R AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit.
- WBC count ≤ 25,000/microliter
- ECOG Performance Status of ≤ 2
- Weight ≥ 40kg
- Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse
- Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study
- Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial
Exclusion criteria
- Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening
- Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening
- Diagnostic assessments: Left ventricular ejection fraction < 45%, Fridericia's corrected QT interval > 470msec, Aspartate aminotransferase and/or alanine aminotransferase > 3 x upper limit of normal (ULN), total bilirubin > 1.5 x ULN, calculated or measured creatinine clearance < 45 mL/minute (multiply by 0.85 if female)
- Infectious disease: HIV positive, active hepatitis B and/or C
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 5 centers
- Monash Health — Clayton
- St. Vincent's Hospital Melbourne — Fitzroy
- The Alfred Hospital — Melbourne
- Hollywood Private Hospital — Nedlands
- Royal Perth Hospital — Perth
United Kingdom · 4 centers
- University Hospital of Wales — Cardiff
- Beatson West of Scotland Cancer Centre — Glasgow
- The Royal Marsden Hospital — London
- Sarah Cannon Research Institute UK — London
Identifiers
NCT: NCT06372717 · AP30CP01