Phase 2 Leukaemia Trial, Recruiting NCT05963074 Sponsor: Janssen Research & Development, LLC Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT05963074
Recruiting Phase 2

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 diagnosed with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) according to specific 2018 international diagnostic guidelines
  • People in the ibrutinib + venetoclax groups who have a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active to having mild limitations) — confirm with trial site for details
  • People in the ibrutinib-alone groups who have a general health and activity level rated as 0, 1, or 2 on that same scale (meaning fully active to being up and about more than half the day) — confirm with trial site for details
  • People who have at least one enlarged lymph node measuring 1.5 centimetres or more, visible on a CT scan
  • People who use oral contraceptives must also use an additional form of contraception during the trial
  • People who are not pregnant, not breastfeeding, and not planning to become pregnant during the trial or for at least one month after the last dose (or longer depending on the country — for example, three months in the European Union and Canada)

Who may not be able to join:

  • People with uncontrolled autoimmune conditions that are causing their red blood cells or platelets to be destroyed, particularly if this has been happening in the four weeks before the first dose, or if high-dose steroid treatment is needed to manage the condition
  • People with known bleeding disorders, such as von Willebrand's disease or haemophilia
  • People who have had a stroke or bleeding in the brain within the six months before enrolling
  • People with a known or suspected transformation of their leukaemia into a more aggressive form, or where the disease has spread to the brain or spinal cord
  • People with significant, currently active heart conditions — such as an uncontrolled irregular heartbeat or moderate-to-severe heart failure

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 12 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: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

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
30 May 2024
Est. completion
15 December 2027

Where this trial is recruiting

🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇭🇺 Hungary 🇮🇹 Italy 🇵🇱 Poland 🇪🇸 Spain 🇺🇸 United States

Primary endpoints

Best Overall Response Rate (ORR)

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: 12 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