Phase 3 Leukaemia Trial, Recruiting NCT06051409 Sponsor: Ascentage Pharma Group Inc. Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT06051409
Recruiting Phase 3 🇦🇺 Australian site

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 who have been newly diagnosed with a specific type of blood cancer called Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL)
  • People whose doctors expect them to survive for at least 3 months
  • People who are reasonably able to carry out daily activities (measured by a standard medical scale called ECOG, with a score of 2 or lower — confirm with trial site if unsure what this means for a specific situation)
  • People whose major organs (such as the liver and kidneys) are functioning at an adequate level

Who may not be able to join:

  • People who have a history of a blood cancer called chronic myeloid leukemia (CML)
  • People whose leukemia has spread to the brain or spinal fluid, or to other parts of the body outside the bone marrow — although swollen lymph nodes or an enlarged liver or spleen may still be permitted (confirm with trial site)
  • People who have had or currently have a disease affecting the brain or nervous system
  • People who have an autoimmune disease that may affect the brain or nervous system
  • People who are taking full treatment doses of blood-thinning or anti-clotting medications (low doses may be permitted — confirm with trial site)
  • People who are currently taking a medication that is known to interact with the trial drug, if taken within 7 days before starting the trial (or within 5 half-lives of that drug, whichever is shorter)
  • People with heart disease that is not well controlled
  • People who have had a blood clot in a vein — such as a deep vein thrombosis or a clot in the lungs — within the 6 months before joining the trial
  • People who are taking medications that are not permitted under the trial rules
  • People with an unstable medical condition that could affect their safety or ability to follow the study requirements
  • People taking medications known to affect the heart's electrical activity in a specific way (called QT prolongation — confirm with trial site)
  • People with an active infection that requires treatment throughout the whole body (such as antibiotics or antifungals)
  • People with a condition that seriously affects their ability to swallow or absorb oral medications, or who have an active stomach or intestinal ulcer
  • People for whom steroid medications (called glucocorticoids) are medically unsuitable
  • People who have a bleeding disorder that is not related to their leukemia
  • People who are planning to have major surgery during the trial period
  • People who are allergic to any of the ingredients or similar substances in the trial medications
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study period
  • People who have been diagnosed with another type of cancer within the past 2 years
  • People with any other symptom, illness, or condition that the trial team considers would interfere with the study or make participation unsuitable

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 9 July 2026
Phase 3: approximately ~65% 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: Elias Jabbour, M.D., M.D. Anderson Cancer Center

Phone: 301-291-5658

Australian sites

Royal North Shore Hospital, St Leonards, New South Wales
Royal Adelaide Hospital, Adelaide, South Australia
Alfred Health, Melbourne, Victoria
Royal Perth Hospital, Perth, Washington

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 3
Sponsor
Ascentage Pharma Group Inc.
Registry
ClinicalTrials.gov
Start date
31 August 2023
Est. completion
31 December 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇨🇿 Czechia 🇫🇷 France 🇮🇹 Italy 🇷🇴 Romania 🇸🇬 Singapore 🇰🇷 South Korea 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Minimal Residual Disease Negative CR Rate

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: 9 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