Chronic Lymphocytic LeukemiaPhase 2ESR-23-22182NCT07014917
Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL
A Phase 2 study testing Venetoclax and Acalabrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Zulfa Omer at 1 site in United States.
Trial summary
This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, CLL Variant
- What is being tested?
- Venetoclax and Acalabrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2025to 5 Jun 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) as defined by the IWCLL including variation of flow cytometry, provided cytogenetic or mutational data are supportive of CLL/SLL diagnosis that requires therapy by one IWCLL criteria; and, must be previously untreated CLL/SLL.
- Note: Variation in flow cytometry is defined as patients who have atypical immunophenotyping for CLL (CD5 negative, CD23 negative or surface expression of CD79b that is bright) but clinically behave like CLL (leukocytosis, lymphadenopathy and splenomegaly) and have the FISH/Cytogenetics translocations (del 13q, trisomy 12, Del11q) or genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL
- Men and Women ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Subjects must have adequate organ and marrow function as defined below:
- ANC ≥1,000/mcL, unless if neutropenia is due to extensive underlying CLL bone marrow disease then platelet threshold will be ANC ≥500/mcL unless WBC is > to 50 x 109/L. If WBC is > to 50 x 109/L there will be no lower threshold of ANC. Use of steroids for disease control is allowed.
Show all 15Show fewer
- Platelets ≥30,000/mcL unless thrombocytopenia is due to extensive underlying CLL bone marrow disease platelets threshold will be ≥ 10, 000/mcl. Use of steroids for disease control is allowed.
- Total bilirubin ≤1.5 x ULN unless directly attributable to Gilbert's syndrome
- AST and ALT ≤3 × ULN
- Creatinine clearance (Cockcroft) ≥30 mL/min/1.73 m2 • CrCl by Cockcroft and Gault method: CrCl (mL/min) = (140 - age [years]) × weight (kg) × (F)a (72 × serum creatinine mg/dL a where F = 0.85 for females and F = 1 for males ≥ 30 mL/minute
- Female subjects who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib.
- Male subjects who are sexually active must agree to use highly effective forms of contraception with the addition of a barrier method (condom) during the study.
- Men must agree to refrain from sperm donation during the study.
- Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing tablets without difficulty.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Who cannot join
- Evidence of any active concurrent disease (such as severe or uncontrolled systemic diseases that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.
- Patients with active Richter's transformation.
- History of or ongoing confirmed central nervous system (CNS) lymphoma.
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
- History of prior malignancy that could affect compliance with the protocol or interpretation of results in the opinion of the investigator, except for the following:
Show all 30Show fewer
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix, breast or prostate at any time prior to study that are adequately treated. Patients with cancer not requiring therapy (ex: early prostate cancer under observation, should be discussed with Study PI).
- Continuation of maintenance therapy in patients with adequately treated malignancy
- Other cancers not specified above that have been curatively treated by surgery and/or radiation therapy and/or chemotherapy from which subject is disease-free for ≥3 years without further treatment
- Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification at Screening.
- Note: Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.
- Patients with a condition that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment. For example, refractory nausea and vomiting, inability to swallow the formulated product, or malabsorption syndrome; chronic gastrointestinal disease gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection.
- Received a live virus vaccination within 28 days of first dose of study drug.
- Uncontrolled HIV infection.
- History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML).
- Any active uncontrolled significant infection (e.g., bacterial, viral or fungal), including subjects with positive cytomegalovirus [CMV] DNA polymerase chain reaction [PCR]).
- Serologic status reflecting active hepatitis B or C infection.
- Note: Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before randomization and must be willing to undergo DNA PCR testing during the study. Those who are HbsAg-positive or hepatitis B PCR positive will be excluded.
- Subjects who are hepatitis C antibody positive will need to have a negative PCR result before randomization. Those who are hepatitis C PCR positive will be excluded.
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug.
- Uncontrolled bleeding diathesis (e.g., hemophilia, von Willebrand disease).
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
- Note: DOAC or LMWH are not exclusionary.
- Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited. Patient who have started those inhibitor or inducers with known dose outside above timeline will follow dose reduction schedule provided in the protocol and package insert of venetoclax and acalabrutinib.
- Breastfeeding or pregnant.
- Concurrent participation in another therapeutic clinical trial.
- Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk.
- Requires treatment with P-glycoprotein (P-gp) inhibitor during venetoclax initiating and dose escalation phase.
- Note: After initiation of the study drug(s) once a stable dose is reached if P-gp inhibitors are required then these P-gp inhibitors will be allowed per the reduction tables within the protocol or per the study drug(s) package insert/IB.
- Patients who are unable to receive Prevnar vaccination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zulfa Omer, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Christine Vollmer, 5132133203, mccordce@ucmail.uc.edu
Zulfa Omer, MD
About this study
Official title: Randomized Phase II Study of Intermittent Versus Continuous Venetoclax Therapy With Acalabrutinib in Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This
This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Read the detailed description
This study is a two-arm, open label, Phase II multicenter clinical trial designed to evaluate the intermittent and continuous venetoclax + acalabrutinib in 2 arms in previously untreated CLL/SLL.
Phase II trial will be in two separate arms using Simon's 2-stage design for each. Subjects will be randomized with 2:1 ratio into Arm A which will receive intermittent venetoclax (7days administration per cycle) + acalabrutinib and Arm B which will receive continuous venetoclax (28 days administrations per cycle) + acalabrutinib.
With this trial we are seeking to establish efficacy of the combination therapy in both treatment models (intermittent and continuous venetoclax) and to acquire pilot data characterizing the effectiveness of the combination in increasing the depth of response as reflected in the rate of uMRD CR. We will reject the null hypothesis for each arm separately if CR at Cycle 12 obtained in 8 patients in Arm A and 5 patients in Arm B and move forward for a larger phase 3 study.
A continuous toxicity monitoring model to monitor adverse events will be used. This model has been used successfully with phase II trials designed with the Simon 2-Stage. This methodology will allow us to monitor the cumulative number of toxic events after each patient is treated and hence to stop the study if the drug toxicities exceeded the prespecified toxicity boundary.
- Being tested
- Venetoclax, Acalabrutinib
- Keywords
- Venetoclax, Acalabrutinib, CLL, SLL
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
intermittent venetoclax (7days administration per cycle) + acalabrutinib
AcalabrutinibDrug
intermittent venetoclax (7days administration per cycle) + acalabrutinib
VenetoclaxDrug
continuous venetoclax (28 days administrations per cycle) + acalabrutinib
AcalabrutinibDrug
continuous venetoclax (28 days administrations per cycle) + acalabrutinib
| Study group | Role | What they receive |
|---|---|---|
| Arm A: intermittent venetoclax | Experimental | intermittent venetoclax (7days administration per cycle) + acalabrutinib Receives: Drug: Venetoclax; Drug: Acalabrutinib |
| Arm B: continuous venetoclax | Experimental | continuous venetoclax (28 days administrations per cycle) + acalabrutinib Receives: Drug: Venetoclax; Drug: Acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission defined by the IWCLL 2018 criteria
Complete Remission (CR) as defined by the IWCLL 2018 criteria after 12 cycles of treatment with acalabrutinib in combination with intermittent or continuous venetoclax in patients with untreated CLL/SLL.
Measured: Post 12 cycles of treatment (each cycle is 28 days)
Secondary outcomes (7)
Circulating numbers of NK cells measured by flow cytometry
Circulating numbers of NK cells using flow cytometry in both treatment arms at pretreatment, C1, C4, C6, C9, C12 and 3 months after completion of treatment.
Measured: Pretreatment, Cycle1, Cycle4, Cycle6, Cycle9, Cycle12 and 3 months after completion of treatment (each cycle is 28 days)
Circulating numbers of T cells measured by flow cytometry
Circulating numbers of T cells using flow cytometry in both treatment arms at pretreatment, C1, C4, C6, C9, C12 and 3 months after completion of treatment.
Measured: Pretreatment, Cycle1, Cycle4, Cycle6, Cycle9, Cycle12 and 3 months after completion of treatment (each cycle is 28 days)
Overall Survival -defined as time from study randomization to death or last follow up
Overall Survival (OS) defined as time from study randomization to death or last follow up
Measured: From date of patient baseline visit to death or last follow up (up to 5 years post treatment).
Progression Free Survival (PFS) defined as the time from study randomization to disease progression, death, or last follow up after treatment
Progression Free Survival (PFS) defined as the time from study randomization to disease progression, death, or last follow up after treatment with acalabrutinib in combination with intermittent or continuous venetoclax in patients with untreated CLL/SLL.
Measured: From date of patient baseline visit to death or last follow up (up to 5 years post treatment).
uMRD Complete Remission (CR) defined by negative luekemia cell to 10-6 using NGS Clonoseq
The rate of uMRD Complete Remission (CR) defined by negative luekemia cell to 10-6 using NGS Clonoseq from bone marrow and peripheral blood samples after 12 cycles of treatment with acalabrutinib in combination with intermittent or continuous venetoclax in patients with untreated CLL/SLL.
Measured: Post 12 cycles of treatment (each cycle is 28 days)
Rate of Tumor lysis syndrome
Tumor lysis syndrome (TLS) after outpatient rapid dose escalation of venetoclax in both treatment arms.
Measured: Cycle 4 of therapy (each cycle is 28 days); post intervention point of outpatient rapid dose escalation of venetoclax
Response to vaccination measured by Levels of antibody titer
Levels of antibody titer in response to vaccination with Prevnar 20 at 3 months (+/- 1 month) from completion of all treatment.
Measured: 3 months (+/- 1 month) from completion of all treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start5 Dec 2025
- Primary completion5 Jun 2028 (estimated)
- Study completion5 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, open label Subjects will be randomized with 2:1 ratio into Arm A which will receive intermittent venetoclax (7days administration per cycle) + acalabrutinib and Arm B which will receive continuous venetoclax (28 days administrations per cycle) + acalabrutinib.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zulfa Omer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zulfa Omer, University of Cincinnati
- Investigators
- Zulfa Omer, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014917
- Sponsor's protocol ID
- UCCC-HEM-23-01
- Acronym
- ESR-23-22182
- Status last verified
- Jan 2026
- First submitted
- 5 May 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Intermittent Versus Continuous Venetoclax Therapy With Acalabrutinib in Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Variants of This
- ClinicalTrials.gov ID
- NCT07014917
- Acronym / sponsor ID
- ESR-23-22182 / UCCC-HEM-23-01
- Keywords
- Venetoclax, Acalabrutinib, CLL, SLL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Zulfa OmerUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 5 Jun 2028 (estimated)
- Study completion
- 5 Jun 2032 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Detailed description
This study is a two-arm, open label, Phase II multicenter clinical trial designed to evaluate the intermittent and continuous venetoclax + acalabrutinib in 2 arms in previously untreated CLL/SLL.
Phase II trial will be in two separate arms using Simon's 2-stage design for each. Subjects will be randomized with 2:1 ratio into Arm A which will receive intermittent venetoclax (7days administration per cycle) + acalabrutinib and Arm B which will receive continuous venetoclax (28 days administrations per cycle) + acalabrutinib.
With this trial we are seeking to establish efficacy of the combination therapy in both treatment models (intermittent and continuous venetoclax) and to acquire pilot data characterizing the effectiveness of the combination in increasing the depth of response as reflected in the rate of uMRD CR. We will reject the null hypothesis for each arm separately if CR at Cycle 12 obtained in 8 patients in Arm A and 5 patients in Arm B and move forward for a larger phase 3 study.
A continuous toxicity monitoring model to monitor adverse events will be used. This model has been used successfully with phase II trials designed with the Simon 2-Stage. This methodology will allow us to monitor the cumulative number of toxic events after each patient is treated and hence to stop the study if the drug toxicities exceeded the prespecified toxicity boundary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, open label Subjects will be randomized with 2:1 ratio into Arm A which will receive intermittent venetoclax (7days administration per cycle) + acalabrutinib and Arm B which will receive continuous venetoclax (28 days administrations per cycle) + acalabrutinib.
| Arm | Type | Receives |
|---|---|---|
| Arm A: intermittent venetoclax | Experimental | Drug: Venetoclax, Drug: Acalabrutinibintermittent venetoclax (7days administration per cycle) + acalabrutinib |
| Arm B: continuous venetoclax | Experimental | Drug: Venetoclax, Drug: Acalabrutinibcontinuous venetoclax (28 days administrations per cycle) + acalabrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) as defined by the IWCLL including variation of flow cytometry, provided cytogenetic or mutational data are supportive of CLL/SLL diagnosis that requires therapy by one IWCLL criteria; and, must be previously untreated CLL/SLL.
- Men and Women ≥18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Subjects must have adequate organ and marrow function as defined below:
- Female subjects who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib.
Key exclusion criteria (30 listed)
- Evidence of any active concurrent disease (such as severe or uncontrolled systemic diseases that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.
- Patients with active Richter's transformation.
- History of or ongoing confirmed central nervous system (CNS) lymphoma.
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
- Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venetoclaxintermittent venetoclax (7days administration per cycle) + acalabrutinib | Drug | Arm A: intermittent venetoclax |
| Acalabrutinibintermittent venetoclax (7days administration per cycle) + acalabrutinib | Drug | Arm A: intermittent venetoclax |
| Venetoclaxcontinuous venetoclax (28 days administrations per cycle) + acalabrutinib | Drug | Arm B: continuous venetoclax |
| Acalabrutinibcontinuous venetoclax (28 days administrations per cycle) + acalabrutinib | Drug | Arm B: continuous venetoclax |
Primary outcome
Complete Remission defined by the IWCLL 2018 criteria
Time frame: Post 12 cycles of treatment (each cycle is 28 days)
Complete Remission (CR) as defined by the IWCLL 2018 criteria after 12 cycles of treatment with acalabrutinib in combination with intermittent or continuous venetoclax in patients with untreated CLL/SLL.
7 secondary outcomes
Circulating numbers of NK cells measured by flow cytometry
Time frame: Pretreatment, Cycle1, Cycle4, Cycle6, Cycle9, Cycle12 and 3 months after completion of treatment (each cycle is 28 days)
Circulating numbers of T cells measured by flow cytometry
Time frame: Pretreatment, Cycle1, Cycle4, Cycle6, Cycle9, Cycle12 and 3 months after completion of treatment (each cycle is 28 days)
Overall Survival -defined as time from study randomization to death or last follow up
Time frame: From date of patient baseline visit to death or last follow up (up to 5 years post treatment).
Progression Free Survival (PFS) defined as the time from study randomization to disease progression, death, or last follow up after treatment
Time frame: From date of patient baseline visit to death or last follow up (up to 5 years post treatment).
uMRD Complete Remission (CR) defined by negative luekemia cell to 10-6 using NGS Clonoseq
Time frame: Post 12 cycles of treatment (each cycle is 28 days)
Rate of Tumor lysis syndrome
Time frame: Cycle 4 of therapy (each cycle is 28 days); post intervention point of outpatient rapid dose escalation of venetoclax
Response to vaccination measured by Levels of antibody titer
Time frame: 3 months (+/- 1 month) from completion of all treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Lymphocytic Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Nemtabrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) Refractory to Covalent Bruton Tyrosine Kinase Inhibitor or Pirtobrutinib and Previously Treated With a BCL2 Inhibitor
Chronic Lymphocytic Leukemia, Small Lymphocytic Leukemia
RecruitingObservational study
Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)
Waldenstrom Macroglobulinemia, Lymphoplasmacytic Lymphoma
RecruitingPhase 3
A Study of Nemtabrutinib Plus Venetoclax vs Venetoclax + Rituximab (VR) in Second-line (2L) + Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (MK-1026-010/BELLWAVE-010).
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Chronic Lymphocytic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zulfa Omer, MD contact
Zulfa Omer principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venetoclax and Acalabrutinib in people with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, run by Zulfa Omer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact UCCC Clinical Trials Office (513-584-7698, cancer@uchealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission defined by the IWCLL 2018 criteria (time frame: Post 12 cycles of treatment (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.