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RecruitingPhase 2

Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab

The MAVRiC Study: A Phase II Study of Disease Risk Mutation Guided Finite Duration Acalabrutinib Plus Venetoclax for Relapse in CLL/SLL After First-line Finite Covalent BTKi Plus BCL2i Combination, With or Without Obinutuzumab

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 130 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well acalabrutinib plus venetoclax works and how safe it is when given for a set time. It is for adults whose CLL or SLL, types of blood cancer, has returned after their first treatment with a covalent BTK blocker and a BCL2 blocker, with or without obinutuzumab. That treatment must have helped control the cancer for at least two years after it ended.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old when signing the consent form.
  • Have CLL or SLL diagnosed using the study’s required guidelines.
  • Have had a set-length first treatment with a covalent BTK blocker plus a BCL2 blocker, with or without obinutuzumab. The cancer must have at least partly improved, and treatment must have ended at least two years ago.
  • Have results or samples ready before treatment for tests of cancer cell changes called IGHV, del(17p), and TP53.
  • Be able to care for yourself and be up and about for at least half of your waking hours.
  • Have organs and bone marrow, the tissue that makes blood cells, working well enough.

Who can't join

  • Have an illness the study doctor thinks makes joining unsafe or unsuitable, or serious heart, blood vessel, or brain blood vessel disease.
  • Have active bleeding or a history of a bleeding disorder, or need warfarin or a similar blood thinner.
  • Have moderate or severe liver scarring, called cirrhosis, or an active hepatitis B or C infection.
  • Have a past or current cancer.
  • Have HIV or a history of PML, a serious brain infection.
  • Have used more than 20 mg of a corticosteroid medicine within one week before the first study dose.
  • Have had an allergic reaction to a study drug, or need a medicine that strongly affects CYP3A4, a protein that helps break down drugs.
  • Have had major surgery within 30 days before the first study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Main Inclusion Criteria: 1. Participant must be ≥ 18 years at the time of signing informed consent. 2. Diagnosis of CLL/SLL according to 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 ≥ PR (i.e., CR, CRi, 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: 1. IGHV (mutated vs. unmutated) 2. del(17p) (present or absent) 3. TP53 mutation (present or absent) 5. ECOG performance status 0, 1 or 2 6. Adequate organ and bone marrow (BM) function. Main Exclusion Criteria: 1. Any evidence of diseases that, in the investigator's opinion, makes it undesirable for patient to participate in the study. 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. 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.

Study sites (5)

MA

NC