Printed from Voxsanity (voxsanity.com.au) — NCT06588478 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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 (chronic lymphocytic leukaemia) or SLL (small lymphocytic lymphoma), as defined by established 2018 medical guidelines.
Part 1 (previously treated patients): People who have received at least 1 but no more than 3 prior treatments for CLL/SLL, including a specific type of targeted therapy called a covalent BTK inhibitor, and whose 17p deletion status (a genetic marker) is known — either positive or negative.
Part 2 (untreated patients): People who have never received treatment for CLL/SLL and who have a specific genetic marker called a 17p deletion (positive result).
People whose condition currently meets established medical guidelines indicating that treatment should begin.
People who are able to swallow oral (tablet or capsule) medication.
People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are fully active to capable of limited self-care (confirm with trial site).
Who may not be able to join:
People who have previously been treated with a BTK degrader or a noncovalent BTK inhibitor (a different type of BTK-targeting therapy).
People who have experienced a serious (Grade 3 or higher) bleeding episode caused by treatment with a BTK inhibitor.
People who have known or suspected Richter's transformation (where CLL/SLL has changed into a more aggressive type of lymphoma).
People with known or suspected involvement of CLL/SLL in the central nervous system (brain or spinal cord).
People who have had or currently have a separate, different cancer within the 3 years before joining the trial — though exceptions may be considered with approval from the trial sponsor for certain lower-risk cancers, such as:
Non-melanoma skin cancer or a slow-growing form of melanoma (lentigo maligna melanoma)
Cervical carcinoma in situ (very early-stage cervical cell changes)
Localised prostate cancer being managed through active monitoring rather than active treatment
Localised breast cancer (not spread to lymph nodes) with no signs of active disease for more than 3 years, including cases where hormonal therapy is still being received
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 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: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
ICON Cancer Centre - Kurralta Park, Kurralta Park,
Latrobe Regional Health, Traralgon,
Calvary Mater Newcastle, Waratah,
0240143021
The Perth Blood Institute - West Perth, West Perth,
Princess Alexandra Hospital, Woolloongabba,
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.
Voxsanity
Clinical trials and treatments, explained plainly · voxsanity.com.au
Date:
To: My Doctor
Re: Clinical trial enquiry
I am writing to enquire about the following clinical trial which may be relevant to my care:
Trial: NCT06588478
Sponsor: Loxo Oncology, Inc.
Phase: Phase 2
Status: Recruiting
Condition: Lymphoma
Trial contact: 1-317-615-4559
More information: https://clinicaltrials.gov/study/NCT06588478
Eligibility summary (AI generated)
Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.
Who might be able to join this trial:
People who have a confirmed diagnosis of CLL (chronic lymphocytic leukaemia) or SLL (small lymphocytic lymphoma), as defined by established 2018 medical guidelines.
Part 1 (previously treated patients): People who have received at least 1 but no more than 3 prior treatments for CLL/SLL, including a specific type of targeted therapy called a covalent BTK inhibitor, and whose 17p deletion status (a genetic marker) is known — either positive or negative.
Part 2 (untreated patients): People who have never received treatment for CLL/SLL and who have a specific genetic marker called a 17p deletion (positive result).
People whose condition currently meets established medical guidelines indicating that treatment should begin.
People who are able to swallow oral (tablet or capsule) medication.
People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (ECOG), meaning they are fully active to capable of limited self-care (confirm with trial site).
Who may not be able to join:
People who have previously been treated with a BTK degrader or a noncovalent BTK inhibitor (a different type of BTK-targeting therapy).
People who have experienced a serious (Grade 3 or higher) bleeding episode caused by treatment with a BTK inhibitor.
People who have known or suspected Richter's transformation (where CLL/SLL has changed into a more aggressive type of lymphoma).
People with known or suspected involvement of CLL/SLL in the central nervous system (brain or spinal cord).
People who have had or currently have a separate, different cancer within the 3 years before joining the trial — though exceptions may be considered with approval from the trial sponsor for certain lower-risk cancers, such as:
Non-melanoma skin cancer or a slow-growing form of melanoma (lentigo maligna melanoma)
Cervical carcinoma in situ (very early-stage cervical cell changes)
Localised prostate cancer being managed through active monitoring rather than active treatment
Localised breast cancer (not spread to lymph nodes) with no signs of active disease for more than 3 years, including cases where hormonal therapy is still being received
Important: Always verify eligibility with the trial site directly before applying.
Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.
This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 23 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.
Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Loxo Oncology, Inc.
Registry
ClinicalTrials.gov
Start date
3 January 2025
Est. completion
1 June 2028
Where this trial is recruiting
🇦🇺 Australia
🇧🇪 Belgium
🇨🇦 Canada
🇨🇿 Czechia
🇩🇰 Denmark
🇫🇷 France
🇩🇪 Germany
🇬🇷 Greece
🇭🇺 Hungary
🇮🇹 Italy
🇵🇱 Poland
🇷🇴 Romania
🇸🇰 Slovakia
🇰🇷 South Korea
🇪🇸 Spain
Turkey (Türkiye)
🇬🇧 United Kingdom
🇺🇸 United States
10 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Overall Response Rate
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.
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.