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Therapy with ibrutinib for patients with Chronic lymphocytic leukemia with subclonal TP53 aberrations
EU CTIS ID: 2024-514823-41-00
What this study is testing
To characterize the dynamics of the clonal composition in progressive CLL patients harboring TP53 mutations detected by NGS, at different time points (Baseline, Weeks 2,4, 12,24,48,72, 96 and then every year until the end of study, at disease progression)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- >=18 years old
- Documented diagnosis of CLL according to International workshop on CLL (IwCLL) 2008 criteria
- Previously untreated (steroid treatment previously administered to control autoimmune complications is allowed)
- Negative HBsAg and negative HBcAb or positive HBcAb and negative for HBV DNA by quantitative PCR, HCV antibody negative or, in case of HCV antibody positive, HCV RNA negative
- Progressive disease requiring treatment according to IwCLL 2008 criteria
- Cohort 2 only: Evidence of a small (<20%) subclone carrying TP53 deletion by FISH
You likely can't join if
- Histologically documented transformation from CLL to aggressive lymphoma (Richter transformation)
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Concomitant use of warfarin or other Vitamin K antagonists
- Requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor
- Evidence of clonal TP53 mutations detected by Sanger sequencing and/or del17p in =20% of the nuclei by FISH
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.