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Chronic Lymphocytic LeukemiaPhase 2NCT04660045

Early Intervention With Acalabrutinib in Patients With High Risk CLL

A Phase 2 study testing Acalabrutinib in people with Chronic Lymphocytic Leukemia and CLL/SLL, run by Weill Medical College of Cornell University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study evaluates the effectiveness of acalabrutinib treatment in patients with chronic lymphocytic leukemia (CLL) deemed at high risk for Richter's Transformation (RT). This is a single arm study. Enrolled patients will initiate therapy with acalabrutinib and will dose continuously. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia, CLL/SLL
What is being tested?
Acalabrutinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2022to Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Subject must be able to voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
  • The time from diagnosis to consent should be ≤6 months.
  • Subject must be ≥ 18 years of age.
  • Subject must have diagnosis of CLL/SLL based upon 2018 iwCLL Guidelines.
  • Rai stage 0-2 disease without indication for treatment as defined by the 2018 iwCLL guidelines
  • Subject must have high risk CLL as defined by any one of the following:
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  • NOTCH1 mutated (classic frameshift mutation only)
  • Unmutated V4-39 B cell receptor usage
  • Pathogenic c-MYC mutations
  • Complex karyotype, (by CpG/oligodeoxynucleotide stimulation)
  • Deletion 17p, or presence of TP53 mutation
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
  • PT/PTT/INR within 1.5 x the ULN
  • Adequate renal function defined by serum creatinine less than 2 x ULN
  • Adequate hepatic function:
  • ALT/AST less than 2x ULN
  • Tbili less than 1.5 X ULN unless bilirubin elevation is due to Gilbert's syndrome (total bilirubin <3)
  • Subject must have adequate bone marrow function.
  • Absolute neutrophil count ≥1.0 x103/μL
  • Hemoglobin ≥ 11.0 g/dL
  • Platelets ≥ 100 x 103/μL

Who cannot join

  • Previous exposure to any systemic anti-cancer therapy as a treatment for CLL, including but not limited to chemotherapy, immunotherapy, radiotherapy, or investigational therapy. Note, patients treated with chemotherapy for a prior non-hematologic malignancy if more than 5 years earlier are eligible.
  • Subject with a history of malignancy except for non-melanoma skin cancers. Subjects treated with curative intent via methods of local resection and or locally targeted anticancer treatment and are free of malignancy for at least 5 years from treatment end will be allowed to enroll.
  • Subject requires chronic immunosuppressive therapy for any reason or was treated with immunosuppressive therapy within 6 months of study entry.
  • Subjects with a history of autoimmune hemolytic anemia or immune thrombocytopenia purpura.
  • Subject has prolymphocytic leukemia.
  • Active bleeding, or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease)
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  • Subject requires warfarin or equivalent vitamin K antagonist
  • Uncontrolled or active significant infection,
  • History of or suspected or confirmed PML
  • Clinically significant cardiovascular disease such as uncontrolled or 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. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.
  • Patients with stroke or CNS hemorrhage within 6 months
  • Pregnant or breastfeeding
  • Women of childbearing potential (WCBP) who are sexually active with heterosexual partners must agree to use highly effective methods of contraception during treatment and for 2 days after the last dose of acalabrutinib.
  • Major surgical procedure within 28 days of first dose of study drug. If a subject had surgery, they must have recovered adequately from any toxicity or complications before the first dose of study drug.
  • Has difficulty with or is unable to swallow oral medication or has significant gastrointestinal disease that would limit absorption of oral medication.
  • Subject is known to be positive for human immunodeficiency virus (HIV)
  • Active hepatitis C, as confirmed by being positive for Hep C RNA by PCR
  • Active hepatitis B infection documented by a positive PCR for Hep B DNA. If hepatitis B serology is positive for hepatitis B core antibody, but Hep B DNA PCR is negative, patient is eligible to enroll.
  • Subject requires strong CYP 3A4/5 inhibitors or inducers (Appendix B).
  • Subject requires proton pump inhibitors. (Subjects that can transition to an H2 antagonist are allowed to enroll.)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Weill Cornell Medicine

    New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase II Trial of Early Intervention With Acalabrutinib in Patients With CLL at High Risk for Richter's Transformation

This study evaluates the effectiveness of acalabrutinib treatment in patients with chronic lymphocytic leukemia (CLL) deemed at high risk for Richter's Transformation (RT). This is a single arm study. Enrolled patients will initiate therapy with acalabrutinib and will dose continuously. While on study, subjects will be monitored monthly for the first 3 months, then every three months thereafter until disease progression, discontinuation due to toxicity, death, or study completion.

Read the detailed description

This is a multi-center, single arm, Phase II clinical trial to investigate the effectiveness of acalabrutinib treatment within 6 months of chronic lymphocytic leukemia (CLL) diagnosis for patients with CLL deemed at high risk for Richter's Transformation (RT).

Being tested
Acalabrutinib
Keywords
CLL, untreated
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.

  • AcalabrutinibDrug

    Also called CALQUENCE, ACP-196

    Acalabrutinib, oral, 100 mg BID, continuous

Study groups in NCT04660045
Study groupRoleWhat they receive
AcalabrutinibExperimentalAcalabrutinib 100 mg will be administered orally twice daily continuously in 28-day cycles until treatment is discontinued for any reason.
Receives: Drug: Acalabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of subjects who do not develop Richter's Transformation (RT) within 5 years of study drug administration

    Measured: 5 years

Secondary outcomes (7)

  1. Event-free survival

    Measured from time of study drug administration to time of progression, transformation to a more aggressive histology, treatment discontinuation due to toxicity, or death from any cause.

    Measured: 5 years

  2. Progression-free survival

    Measured from time of study drug administration to progression or death, measured in months.

    Measured: 5 years

  3. Progression-free survival in patients with TP53 disruption

    For subjects with TP53 disruption present at baseline, measured from time of study drug administration to progression or death, measured in months.

    Measured: 5 years

  4. Overall survival

    Measured from time of study drug administration to death from any cause, measured in months.

    Measured: 5 years

  5. Percentage of subjects who do not develop Richter's Transformation within 2 years of study drug administration

    Measured: 2 years

  6. Median time to development of RT

    Measured from time of study drug administration

    Measured: 5 years

  7. Safety of early interventional acalabrutinib in patients with chronic lymphocytic leukemia (CLL) at high risk for Richter's Transformation

    Percentage of subjects who experience 1 or more adverse events.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study startMay 2022 (estimated)
  3. Primary completionJan 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Why it stopped: Company supplying drug/funding ceased support.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660045
Sponsor's protocol ID
20-11022876
Status last verified
Mar 2022
First submitted
2 Dec 2020
Last updated
5 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acalabrutinib in people with Chronic Lymphocytic Leukemia and CLL/SLL, run by Weill Medical College of Cornell University 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 21 inclusion and 20 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: withdrawn, as of the sponsor's last update on 5 Apr 2022. 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects who do not develop Richter's Transformation (RT) within 5 years of study drug administration (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04660045.

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 5 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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