Back to search results

Acalabrutinib and Venetoclax for High-Risk, Recurrent, or Refractory CLL/SLL

This study is testing how well a combination of medicines works for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that is high-risk, has returned (recurrent), or hasn't responded to previous treatments (refractory). The medicines being studied are acalabrutinib, venetoclax, and sometimes obinutuzumab. Acalabrutinib and venetoclax are taken by mouth, while obinutuzumab is given through an IV. Researchers want to see if these treatments can reduce the amount of cancer cells in the bone marrow to very low levels. You might be able to join if you are 18 or older and have CLL/SLL with certain high-risk features, or if your CLL/SLL has returned or not responded to at least one prior treatment. The study is currently unclear on its recruitment status and plans to enroll 168 people.

Study design
This is an interventional study, meaning participants receive specific treatments. It aims to enroll 168 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured up to 1 year after starting treatment, with cycles lasting 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04169737

Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~168 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:AcalabrutinibObinutuzumabVenetoclax

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease assessment of bone marrow (BM) undetectable-minimal residual disease,10-4 sensitivity (MRD4) (Treatment-naive [TN] cohort)
Measured over Up to 1 year end of cycle 9; each cycle 28 days
+1 more outcome measured

Conditions

Recurrent Chronic Lymphocytic Leukemia
Recurrent Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Small Lymphocytic Lymphoma

Explore related trials

Chronic Lymphocytic LeukemiaSmall Lymphocytic LymphomaComplex KaryotypeImmunoglobulin Heavy Chain Variable DomainLoss of Chromosome 11qLoss of Chromosome 17pTP53 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • William G Wierda · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

William G Wierda
[email protected]
713-745-0428
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease
Creatinine clearance \>50 mL/min (calculated according to institutional standards or using Cockcroft-Gault, MDRD, or CKD-EPI formula)
ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement 5. Absolute neutrophil count greater than 750 neutrophils/L, unless thought to be due to marrow infiltration with CLL. Platelet count of greater than 30,000/µl, with no platelet transfusion in 2 weeks prior to registration , unless thought to be due to marrow infiltration with CLL. 6. Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 2 days after the last dose of acalabrutinib, 30 days after the last dose of venetoclax, or 18 months after the last dose of obinutuzumab, whichever is longer. Women of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Men who are sexually active must agree to use highly effective forms of contraception with the addition of a barrier method (condom) during the study and for 30 days after the last dose of venetoclax and for 18 months after the last dose obinutuzumab, whichever is longer. 7. Free of prior malignancies for 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast, who are eligible even if they are currently treated or have been treated and/or diagnosed in the past 2 years prior to study enrolment. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at MD Anderson Cancer Center, and after consultation with the Principal Investigator. 8. Patients must provide written informed consent.

What this trial measures

  • Disease assessment of bone marrow (BM) undetectable-minimal residual disease,10-4 sensitivity (MRD4) (Treatment-naive [TN] cohort)Up to 1 year end of cycle 9; each cycle 28 days
  • Disease assessment of BM undetectable-MRD4 (Relapsed/refractory [R/R] cohort)Up to 1 year end of cycle 14; each cycle 28 days