Phase 3 Lymphoma Trial, Recruiting NCT05947851 Sponsor: Merck Sharp & Dohme LLC Condition: Lymphoma
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Phase 3 Lymphoma Trial, Recruiting

NCT05947851
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:

  • You have been diagnosed with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) and your doctor has determined you need treatment
  • Your cancer has come back or stopped responding to at least one previous treatment
  • You have at least one measurable sign that the cancer is active in your body
  • You are reasonably able to carry out daily activities (your doctor will assess this using a standard scale)
  • Your doctor expects you to live for at least 3 more months
  • You are able to swallow and keep down oral (by mouth) medication
  • Your kidneys, liver, and other organs are working well enough, based on blood tests taken within the last 7 days before joining the study
  • If you have hepatitis B, you may still be eligible if you have been on antiviral treatment for at least 4 weeks and the virus is undetectable in your blood
  • If you have a history of hepatitis C, you may still be eligible if the virus is currently undetectable in your blood
  • If you are living with HIV, you may be eligible if you meet all additional specific requirements (confirm with trial site)
  • If you are able to father a child, you agree to use effective contraception or abstain from sex during and after treatment for a specified period
  • If you were assigned female sex at birth, you are not pregnant or breastfeeding, and either cannot become pregnant or agree to use highly effective contraception and have a negative pregnancy test

Who may not be able to join:

  • You currently have an active hepatitis B or hepatitis C infection
  • You have a digestive or stomach condition that could affect how your body absorbs medication
  • You have another cancer that is growing or has needed active treatment within the last 2 years
  • Your CLL/SLL has transformed into a more aggressive type of lymphoma (Richter Transformation), or the cancer has spread to your brain or spinal cord
  • You currently have an active infection that requires treatment with IV (intravenous) antibiotics
  • You are HIV-positive and have had certain serious HIV-related conditions (such as Kaposi's sarcoma, Multicentric Castleman's Disease, or a severe opportunistic infection) in the past 12 months
  • You have significant heart or blood vessel disease
  • You have a known allergy or sensitivity to any of the study drugs (nemtabrutinib, venetoclax, or rituximab) or their ingredients
  • You have a history of serious bleeding disorders, such as hemophilia
  • You have received cancer treatment too recently before joining the study (the exact timeframe depends on the type of treatment — confirm with trial site)
  • You have taken a specific type of drug called a BCL2 inhibitor within the last 12 months, or had radiotherapy within 2 weeks before starting the study
  • You are currently taking certain other medications that could interact with the study drugs (confirm with trial site)
  • You have received a live vaccine within 30 days before starting the study
  • You have taken part in another clinical trial or used an experimental device within the last 4 weeks
  • You have a mental health or substance use condition that might make it difficult to follow the study requirements
  • You have not fully recovered from a major surgery, or you are still experiencing 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 23 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 Adelaide Hospital ( Site 1104), Adelaide, South Australia
+61870740000
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 1103), Melbourne, Victoria
+61383959130

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
8 August 2023
Est. completion
1 June 2032

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇲🇽 Mexico Puerto Rico 🇿🇦 South Africa 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

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

Primary endpoints

Part 1: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs); Part 1: Number of Participants Experiencing Adverse Events (AEs); Part 1: Number of Participants Discontinuing Study Treatment Due to AEs; Part 2: PFS per the 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria as Assessed by Blinded Independent Central Review (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: 23 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