Phase 3 Leukaemia Trial, Recruiting NCT06136559 Sponsor: Merck Sharp & Dohme LLC Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT06136559
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 a confirmed diagnosis of CLL/SLL (a type of blood cancer) with active disease that doctors have clearly documented as needing treatment to begin.
  • People who have at least one measurable sign of disease burden (confirm with trial site for specific measures).
  • People whose general physical ability and daily functioning falls within an acceptable range, as assessed by a standard medical scale, within 7 days before being enrolled in the trial.
  • People who are able to swallow and keep down oral (tablet or capsule) medication.
  • People who are hepatitis B surface antigen positive may be considered, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and the virus is undetectable in their blood before enrollment.
  • People with a history of hepatitis C infection may be considered, provided the hepatitis C virus is undetectable in their blood at the screening stage.
  • People living with HIV may be considered, provided they meet all other eligibility criteria.

Who may not be able to join:

  • People with a currently active hepatitis B or hepatitis C infection.
  • People with a digestive system condition that could affect how the body absorbs medication.
  • People whose CLL/SLL has transformed into a more aggressive cancer type (Richter Transformation), or whose cancer has spread to the central nervous system (brain and spinal cord).
  • People who have had a serious AIDS-related opportunistic infection within the 12 months before screening.
  • People with significant heart or blood vessel disease.
  • People who have a known allergy or medical reason to avoid nemtabrutinib, ibrutinib, acalabrutinib, or any of the inactive ingredients in these medicines.
  • People with a history of severe bleeding disorders.
  • People with another cancer that is still progressing or has required active treatment within the past 2 years.
  • People who have previously received any systemic (whole-body) anti-cancer treatment for CLL/SLL.
  • People currently taking certain medications that interact with the study drugs, including specific drug transporters or liver enzyme pathways (confirm specific medications with the trial site).
  • People who received radiation therapy within 2 weeks before starting the study, or who still have side effects from radiation that require steroid treatment.
  • People who received a live or live-attenuated vaccine within 30 days before the first dose of the study treatment (non-live/killed vaccines are permitted).
  • People who have taken part in another clinical trial or used an experimental medical device within 4 weeks before starting the study.
  • People with an active infection that requires systemic treatment, including intravenous antibiotics, during the screening period.
  • People who have not fully recovered from major surgery, or who still have ongoing complications from 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 14 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: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Australian sites

Royal North Shore Hospital ( Site 2806), St Leonards, New South Wales

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
Registry
ClinicalTrials.gov
Start date
13 December 2023
Est. completion
7 September 2032

Where this trial is recruiting

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇳 China 🇨🇴 Colombia 🇨🇿 Czechia 🇩🇰 Denmark 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇮🇱 Israel 🇯🇵 Japan 🇲🇾 Malaysia 🇲🇽 Mexico 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇪 Peru 🇵🇱 Poland 🇵🇹 Portugal 🇿🇦 South Africa 🇪🇸 Spain 🇸🇪 Sweden 🇹🇼 Taiwan 🇹🇭 Thailand Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Objective Response Rate (ORR) per Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by Blinded Independent Central Review (BICR); Progression-Free Survival (PFS) per iwCLL Criteria 2018 as assessed by BICR

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: 14 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