Phase 2 study for people with Leukaemia

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Loxo Oncology, Inc.
Registry number NCT06588478
Started 3 January 2025 Today 16 October 2026 Estimated completion 1 June 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Flinders Medical Centre Adelaide SA Recruiting
Bankstown-Lidcombe Hospital Bankstown NSW Recruiting
Box Hill Hospital Box Hill VIC Recruiting
Coffs Harbour Health Campus Coffs Harbour NSW Recruiting
Royal Hobart Hospital Hobart TAS Recruiting
ICON Cancer Centre - Kurralta Park Kurralta Park SA Recruiting
Latrobe Regional Health Traralgon VIC Recruiting
Calvary Mater Newcastle Waratah NSW Recruiting
The Perth Blood Institute - West Perth West Perth WA Recruiting
Princess Alexandra Hospital Woolloongabba QLD Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 249

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Have confirmed diagnosis of CLL/SLL as defined by iwCLL 2018 criteria.

* Part 1: Have received prior CLL/SLL treatment

* Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL

* Have received a covalent BTK inhibitor

* Part 2: Have received no prior treatment for CLL/SLL

* Part 1 - Known 17p deletion status (positive or negative)

* Part 2 - Must have 17p deletion (positive)

* Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy

* Capable of swallowing oral study medication.

* Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.

Exclusion Criteria:

* Have received prior treatment with a BTK degrader or a noncovalent BTK inhibitor

* Have a history of greater than or equal to (\>=) Grade 3 bleeding due to treatment with a BTK inhibitor

* Have known or suspected Richter's transformation

* Have known or suspected history of central nervous system involvement by CLL/SLL

* Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:

* nonmelanoma skin cancer or lentigo malignant melanoma

* cervical carcinoma in situ

* localized prostate cancer undergoing active surveillance, and

* localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy

Dates on the record

Started 3 January 2025
Estimated completion 1 June 2028
Registry last updated 19 May 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 19 May 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.