Phase 2 Leukaemia Trial, Recruiting NCT06395103 Sponsor: Merck Sharp & Dohme LLC Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT06395103
Recruiting Phase 2 🇦🇺 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 with a confirmed diagnosis of a specific blood cancer called B-precursor B-ALL, or a type of lymphoma called DLBCL or Burkitt lymphoma, as classified by the World Health Organization (WHO).
  • People with a confirmed diagnosis of neuroblastoma (a type of nerve tissue cancer) or Ewing sarcoma (a type of bone and soft tissue cancer).

Who may not be able to join:

  • People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant).
  • People with a significant, currently active heart or blood vessel disease.
  • People with a known history of liver cirrhosis (severe liver scarring).
  • People who currently have moderate or severe nerve damage causing symptoms such as numbness or tingling (Grade 2 or higher peripheral neuropathy).
  • People diagnosed with a specific inherited nerve condition called the demyelinating form of Charcot-Marie-Tooth disease.
  • People who have been diagnosed with Down syndrome.
  • People who are currently experiencing graft-versus-host disease (a complication that can follow a stem cell or bone marrow transplant) at any level of severity, or who are receiving treatment or preventive medication for it.
  • People with a known history of HIV infection.
  • People who have a known allergy or medical reason preventing them from receiving the study treatment or any of its ingredients.
  • People who have received radiation therapy within the 4 weeks before the trial starts, or who have not yet fully recovered from side effects of radiation.
  • People who are taking ongoing daily steroid medication (corticosteroids) at a dose higher than the equivalent of 10 mg of prednisone per day, unless that dose has been stable for at least 4 weeks before starting the trial.
  • People who have taken certain strong medications that affect how the body processes other drugs (strong CYP3A4 inhibitors within the past 7 days, or strong CYP3A4 inducers within the past 14 days), or who are expected to need these medications during or for 30 days after the trial treatment (confirm with trial site).
  • People who have received other systemic cancer treatments or experimental therapies within 4 weeks before the first trial dose (with some specific exceptions — confirm with trial site).
  • People who have received a live or live-attenuated vaccine within 30 days before the first trial dose.
  • People who have received another experimental treatment or used an experimental medical device within 4 weeks before starting the trial.
  • People who have another cancer that is currently growing or has required active treatment within the past year.
  • People who currently have an active infection that requires systemic treatment (such as antibiotics given by mouth or through a drip).
  • People with a known history of Hepatitis B, or a currently active Hepatitis C infection.
  • People who have not fully recovered from major surgery, or who have ongoing complications from a recent surgery.

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 2: approximately ~30% 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: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Australian sites

Sydney Children's Hospital ( Site 1997), Randwick, New South Wales
61293821111
Queensland Children's Hospital-Oncology & Haematology ( Site 1996), Brisbane, Queensland
61730681111
Royal Children's Hospital-Children's Cancer Centre ( Site 1994), Melbourne, Victoria
61393455522

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 2
Registry
ClinicalTrials.gov
Start date
16 August 2024
Est. completion
31 March 2029

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇸🇰 Slovakia 🇰🇷 South Korea 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Part 1: Number of Participants from 1 to <18 years of Age Who Experience a Dose-Limiting Toxicity (DLT); Part 1: Number of Participants from 1 to <18 years of Age Who Experience One or More Adverse Events (AEs); Part 1: Number of Participants from 1 to <18 years of Age Who Discontinue Study Treatment Due to AEs; Part 1: Number of Participants from 1 to <18 years of Age Who Receive Dose Modification Due to AEs; Part 1 and Part 2: Objective Response (OR) for Participants with B-Cell Acute Lymphoblastic Leukemia (B-ALL); Part 1 and Part 2: OR for Participants with Diffuse Large B-Cell Lymphoma (D...

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