Clinical Validation Study: Evaluation of TSO Comp (DRAGEN) Assay for Detection of Tumor Protein 53 (TP53) Status in Peripheral Blood From Patients With Myelofibrosis to Support Study KRT-232-115

Clinical Validation Study: Evaluation of TSO Comp (DRAGEN) Assay for Detection of Tumor Protein 53 (TP53) Status in Peripheral Blood From Patients With Myelofibrosis to Support Study KRT-232-115 - ONCO-T05-031

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038983

Enrollment

600

Registered

2026-01-26

Start date

2024-11-16

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis D75.8

Interventions

Group 1: Approximately 180 subjects with TP53 WT/benign status, who have had a suboptimal response to ruxolitinib monotherapy during the run-in period, will be further randomized 2:1 in a double-blind

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subject is enrolled in the KRT-232-115 clinical trial. 2. Subject has an available sample that meets the sample inclusion and exclusion criteria as described in sample inclusion and exclusion criteria (Section 3.8).

Exclusion criteria

Exclusion criteria: 1. Subject does not have an available specimen that was collected/retained under informed consent. 2. Subject has/was withdrawn from the KRT-232-115 clinical trial. 3. Subject does not have appropriate consent.

Design outcomes

Primary

Measure	Time frame
The objective of this clinical performance study is to identify MF subjects who have TP53 WT/benign status and are most likely to benefit from add-on navtemadlin therapy in the KRT-232-115 clinical trial. The following multi-component co-primary endpoints will be assessed in the TSO Comp (DRAGEN) positive (TP53 WT/benign variants) population as described in the KRT-232-115 clinical trial protocol, *The proportion of patients in each arm who achieve an SVR of = 25% (SVR25) from the pre-randomization baseline and an SVR of = 35% (SVR35) from the pre-ruxolitinib baseline. SVR will be evaluated 24 weeks after randomized treatment begins (Cycle 1B Day 1) by MRI (magnetic resonance imaging)/CT (computed tomography) scan (central review). The proportion of patients in each arm who achieve a TSS reduction of = 30% (TSS30) from the pre-randomization baseline and a TSS reduction of = 50% (TSS50) from the pre-ruxolitinib baseline. TSS reduction will be evaluated 24 weeks after randomized treatment begins (Cycle 1B Day 1) using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. Performance of TSO Comp (DRAGEN) assay will be considered acceptable if the results of the KRT-232-115 clinical trial support the efficacy of navtemadlin add-on therapy in the patient population identified by the investigational assay.	—

Measure

Time frame

The objective of this clinical performance study is to identify MF subjects who have TP53 WT/benign status and are most likely to benefit from add-on navtemadlin therapy in the KRT-232-115 clinical trial. The following multi-component co-primary endpoints will be assessed in the TSO Comp (DRAGEN) positive (TP53 WT/benign variants) population as described in the KRT-232-115 clinical trial protocol, *The proportion of patients in each arm who achieve an SVR of = 25% (SVR25) from the pre-randomization baseline and an SVR of = 35% (SVR35) from the pre-ruxolitinib baseline. SVR will be evaluated 24 weeks after randomized treatment begins (Cycle 1B Day 1) by MRI (magnetic resonance imaging)/CT (computed tomography) scan (central review). The proportion of patients in each arm who achieve a TSS reduction of = 30% (TSS30) from the pre-randomization baseline and a TSS reduction of = 50% (TSS50) from the pre-ruxolitinib baseline. TSS reduction will be evaluated 24 weeks after randomized treatment begins (Cycle 1B Day 1) using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0. Performance of TSO Comp (DRAGEN) assay will be considered acceptable if the results of the KRT-232-115 clinical trial support the efficacy of navtemadlin add-on therapy in the patient population identified by the investigational assay.

—

Secondary

Measure	Time frame
No secondary outcomes identified.	—

Countries

Australia, Austria, Belgium, Canada, Croatia, Czechia, France, Georgia, Germany, Greece, Hungary, Italy, New Zealand, Poland, Portugal, Romania, Serbia, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States

Contacts

Public ContactSidney Scutter

Illumina, Inc.

EAR@illumina.com+18582024500

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026