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MAVRiC studies 2L treatment with AV in patients with CLL/SLL who have relapsed after a course of BTKi + BCL2i combination, with and without Obinutuzumab
EU CTIS ID: 2024-518858-17-00
What this study is testing
To determine the efficacy of second-line (2L) treatment with acalabrutinib plus venetoclax (AV) after relapse following first-line (1L) covalent Bruton’s tyrosine kinase inhibitor (cBTKi) + B-cell leukemia/lymphoma-2 inhibitor (BCL2i) by assessment of overall response rate (ORR) in participants with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL)
- 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
- 1. Participant must be ≥ 18 years at the time of signing informed consent.
- 2. Diagnosis of CLL/SLL according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines 2018 (Hallek et al. 2018)
- 3. Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ partial remission (PR) (i.e., complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or PR) with a minimum of 2 years since the end of the prior 1L treatment.
- 4. The following data must be available or at least the appropriate samples drawn/acquired prior to dosing: a) variable region of immunoglobulin heavy chain (IGHV) (mutated vs. unmutated) b) 17p deletion [del(17p)] (present or absent) c) Tumor protein 53 (TP53) mutation (present or absent)
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- 6. Adequate organ and bone marrow (BM) function.
You likely can't join if
- 1. Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.
- 10. History of hypersensitivity or anaphylaxis to study intervention(s).
- 11. Requires treatment with a strong CYP3A4 inhibitor/inducer.
- 12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
- 13. Major surgical procedure within 30 days of the first dose of study intervention.
- 2. Significant cardiovascular or cerebrovascular disease.
See the full eligibility criteria
- 1. Participant must be ≥ 18 years at the time of signing informed consent.
- 2. Diagnosis of CLL/SLL according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines 2018 (Hallek et al. 2018)
- 3. Participants must have received first line treatment with fixed duration covalent BTKi plus BCL2i therapy (± obinutuzumab) with a response ≥ partial remission (PR) (i.e., complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or PR) with a minimum of 2 years since the end of the prior 1L treatment.
- 4. The following data must be available or at least the appropriate samples drawn/acquired prior to dosing: a) variable region of immunoglobulin heavy chain (IGHV) (mutated vs. unmutated) b) 17p deletion [del(17p)] (present or absent) c) Tumor protein 53 (TP53) mutation (present or absent)
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- 6. Adequate organ and bone marrow (BM) function.
- 1. Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study.
- 10. History of hypersensitivity or anaphylaxis to study intervention(s).
- 11. Requires treatment with a strong CYP3A4 inhibitor/inducer.
- 12. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
- 13. Major surgical procedure within 30 days of the first dose of study intervention.
- 2. Significant cardiovascular or cerebrovascular disease.
- 3. Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease).
- 4. Child-Pugh B/C liver cirrhosis.
- 5. History of prior or current malignancy.
- 6. HIV positive
- 7. History of progressive multifocal leukoencephalopathy (PML).
- 8. Active hepatitis B or C infection:
- 9. Corticosteroid use > 20 mg within 1 week before the first dose of study intervention.
The study team makes the final eligibility decision.
Where it's taking place
- United States
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.
Where is this trial taking place?
Study sites include United States. 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 EU CTIS; the study team decides eligibility.