Phase 1 Leukaemia Trial, Recruiting NCT06634394 Sponsor: Aptevo Therapeutics Condition: Leukaemia
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Phase 1 Leukaemia Trial, Recruiting

NCT06634394
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People who have been diagnosed with Acute Myeloid Leukaemia (AML) according to 2016 World Health Organization standards and have not yet received any treatment for it
  • People whose AML has tested positive for a protein called CD123, confirmed through laboratory testing at diagnosis or at the time of screening
  • People whose doctors have determined they are not suitable for standard intensive chemotherapy ("induction therapy"), based on at least one of the following: being 75 years of age or older; having limited physical functioning (ECOG score of 2 or 3); having a heart condition such as heart failure, reduced heart pumping function, or stable chest pain; having a lung condition with reduced lung function; having moderately reduced kidney function within a specific range; or having a liver condition causing mildly to moderately elevated bilirubin levels within a specific range (confirm with trial site)
  • People with an expected life expectancy of at least 12 weeks

Who may not be able to join:

  • People who have previously received certain blood cancer treatments, including hypomethylating agents, venetoclax, or chemotherapy for AML, MDS, CMML, or related blood disorders
  • People who have previously received CAR-T cell therapy or a stem cell transplant from a donor
  • People who have previously received experimental treatments for AML or MDS
  • People who are currently taking part in another clinical research study that involves a treatment intervention
  • People with a history of certain other blood or bone marrow conditions, including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukaemia, or AML with a specific genetic feature called BCR-ABL1
  • People who have a type of leukaemia called acute promyelocytic leukaemia (APL)
  • People with an active autoimmune condition that requires high-dose steroid or immunosuppressive treatment above a certain threshold
  • People currently receiving corticosteroids as part of cancer treatment at any dose
  • People with known active spread of AML to the brain or spinal fluid (note: people who received preventive treatment to the spinal fluid before joining may still be considered eligible — confirm with trial site)
  • People with severely reduced kidney function below a specific threshold (confirm with trial site)
  • People with significantly elevated bilirubin liver levels above three times the normal upper limit, unless they have a condition called Gilbert's Syndrome
  • People with significantly elevated liver enzyme levels (AST and/or ALT) more than three times the normal upper limit

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Dirk Huebner, MD, Aptevo Therapeutics

Phone: 7735749572

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Aptevo Therapeutics
Registry
ClinicalTrials.gov
Start date
1 October 2024
Est. completion
1 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To assess the safety, tolerability, and maximum tolerated dose (MTD) of increasing doses of APVO436 in combination with venetoclax/azacitidine in patients with newly diagnosed AML

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov