Phase 3 Leukaemia Trial, Recruiting NCT05197192 Sponsor: German CLL Study Group Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT05197192
Recruiting Phase 3

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 CLL (chronic lymphocytic leukemia) or SLL (small lymphocytic lymphoma) that doctors have determined needs treatment, based on established medical guidelines
  • People who are at least 18 years old
  • People whose cancer has at least one of the following high-risk features: a missing section of chromosome 17 (17p-deletion), a change in the TP53 gene, a complex set of chromosome abnormalities (3 or more changes across at least 2 cells), or a specific gene pattern called "unmutated IGHV status"
  • People with a life expectancy of at least six months
  • People whose bone marrow is producing enough platelets (a blood cell count above a certain level, as confirmed by a blood test)
  • People whose kidneys are functioning at an adequate level (confirm with trial site for specific threshold)
  • People whose liver is functioning at an adequate level, based on blood test results — unless any abnormality is directly caused by their CLL or a condition called Gilbert's Syndrome
  • People who test negative for hepatitis B and hepatitis C, or who meet specific monitoring conditions if certain hepatitis markers are present (confirm with trial site for full details)
  • People with a general health and activity level rated 0, 1, or 2 on a standard medical scale, meaning they are fully active to capable of limited self-care

Who may not be able to join:

  • People who have previously received any treatment specifically targeting their CLL (with a limited exception for short-term corticosteroid use at low doses in the 10 days before starting the study)
  • People whose CLL does not include any of the high-risk features listed above (17p-deletion, TP53 mutation, or complex chromosome abnormalities)
  • People with serious problems affecting a major organ or body system — for example, advanced heart disease — that could make it unsafe to receive the study treatments or affect how the body absorbs the medications (including people who are unable to swallow tablets)
  • People whose CLL has transformed into a more aggressive type of cancer (known as Richter transformation)
  • People who currently have another type of cancer that requires systemic treatment
  • People with an uncontrolled or active HIV infection, a condition called PML, or any other active serious infection
  • People currently taking blood-thinning medications called warfarin or phenprocoumon
  • People who are pregnant or currently breastfeeding

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: Barbara Eichhorst, MD, Prof., Department I of Internal Medicine, University Hospital Cologne

Phone: +4922147888220

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
German CLL Study Group
Registry
ClinicalTrials.gov
Start date
19 April 2022
Est. completion
1 May 2028

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Progression-free survival (PFS)

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