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New treatment option for Chronic Lymphocytic Leukemia (CLL)
Official title Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab
ClinicalTrials.gov ID: NCT07024706
What this study is testing
What is Acalabrutinib?
Acalabrutinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia (cll).
Also referred to as CALQUENCE®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the efficacy and safety of finite-duration acalabrutinib plus venetoclax therapy in patients with relapsed CLL or SLL, and have previously responded to first line (1L) cBTKi + BCL2i therapy (± obinutuzumab) and maintained a response for at least two years post-treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join if
- Main
- Participant must be ≥ 18 years at the time of signing informed consent.
- Diagnosis of CLL/SLL according to iwCLL guidelines 2018 (Hallek et al. 2018)
- Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR...
- The following data must be available or at least the appropriate samples drawn/acquired prior to dosing:
You likely can't join if
- Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.
- Significant cardiovascular or cerebrovascular disease.
- Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
- Child-Pugh B/C liver cirrhosis.
- History of prior or current malignancy.
- HIV positive
See the full eligibility criteria
- Main
- Participant must be ≥ 18 years at the time of signing informed consent.
- Diagnosis of CLL/SLL according to iwCLL guidelines 2018 (Hallek et al. 2018)
- Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ PR (i.e., CR, CRi, nPR, or PR) with a minimum of 2 years since the end of the...
- The following data must be available or at least the appropriate samples drawn/acquired prior to dosing:
- IGHV (mutated vs. unmutated)
- del(17p) (present or absent)
- TP53 mutation (present or absent)
- ECOG performance status 0, 1 or 2
- Adequate organ and bone marrow (BM) function. Main
- Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.
- Significant cardiovascular or cerebrovascular disease.
- Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
- Child-Pugh B/C liver cirrhosis.
- History of prior or current malignancy.
- HIV positive
- History of progressive multifocal leukoencephalopathy (PML).
- Active hepatitis B or C infection:
- Corticosteroid use \> 20 mg within 1 week before the first dose of study intervention.
- History of hypersensitivity or anaphylaxis to study intervention(s).
- Requires treatment with a strong CYP3A4 inhibitor/inducer.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
- Major surgical procedure within 30 days of the first dose of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Horn, Austria
- Goiânia, Brazil
- Porto Alegre, Brazil
- São Paulo, Brazil
- Brno, Czechia
- Hradec Kralova, Czechia
- Ostrava, Czechia
- Dublin, Ireland
- Meldola, Italy
- Milan, Italy
- Padua, Italy
- Ravenna, Italy
- Rome, Italy
- Torino, Italy
- Bydgoszcz, Poland
- Krakow, Poland
+ 7 more site(s).
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, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Charlotte, North Carolina, United States; Durham, North Carolina, United States; Winston-Salem, North Carolina, United States; Horn, Austria; Goiânia, Brazil and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.