CompletedPhase 1

Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL

United States69 participantsStarted 2014-12-22

Plain-language summary

To evaluate the safety and preliminary efficacy of acalabrutinib in combination with obinutuzumab in 4 separate cohorts of participants.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants with a diagnosis of intermediate or high risk CLL (or variant immunophenotype), SLL, or B-cell prolymphocytic leukemia (B-PLL) by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek et al. 2008) who have:
. Participants in Cohorts 1 and 3 may have received previous ibrutinib (or another Bruton tyrosine kinase (BTK) inhibitor) as long as discontinuation was for a reason other than on-treatment disease progression.
. All participants must satisfy one of the following criteria for active disease requiring therapy:
. This criterion was removed with Amendment 5.
. Participants with a history of Richter's syndrome are eligible if they now have evidence of CLL only, with \<10% large cells in the bone marrow.
. Participants must have adequate organ function, defined as creatinine ≤2.5 times the upper limit of normal range (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, and bilirubin ≤2.5 x ULN. For Cohorts 3 and 4, participants must have creatinine clearance ≥50 mL/min using modified Cockcroft-Gault equation (using Ideal Body Mass \[IBM\] instead of mass):
. IBM (kg) = \[(height cm - 154) ● 0.9\] + (50 if male, 45.5 if female).
. Platelets \>50 x 10\^9/L. In participants with CLL involvement of the marrow, \>30 x 10\^9/L for Cohorts 1 and 2. For Cohorts 3 and 4, participants must have hemoglobin \>9 g/dL.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Objective Response (OR) at 12 Months as Assessed by the Investigator in Cohorts 1 and 2

Timeframe: Day 1 through 12 months

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in all Cohorts

Timeframe: Day 1 through the final data cutoff date (approximately 6 years 8 months)

Number of Participants With Treatment-Emergent Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or 4 Abnormalities in Laboratory Parameters in all Cohorts

Timeframe: Day 1 through the final data cutoff date (approximately 6 years 8 months)

Number of Participants With Abnormal Vital Signs Reported as TEAEs in all Cohorts

Timeframe: Day 1 through the final data cutoff date (approximately 6 years 8 months)

Number of Participants with Shift From Baseline to Worst (Grade 3 and 4) Post-baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status in all Cohorts

Timeframe: Baseline (Days -28 to -1) through the final data cutoff date (approximately 6 years 8 months)

Trial details

NCT IDNCT02296918

SponsorAcerta Pharma BV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-20

View on ClinicalTrials.gov More Chronic Lymphocytic Leukemia trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participants with a diagnosis of intermediate or high risk CLL (or variant immunophenotype), SLL, or B-cell prolymphocytic leukemia (B-PLL) by International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria (Hallek et al. 2008) who have:
. Participants in Cohorts 1 and 3 may have received previous ibrutinib (or another Bruton tyrosine kinase (BTK) inhibitor) as long as discontinuation was for a reason other than on-treatment disease progression.
. All participants must satisfy one of the following criteria for active disease requiring therapy:
. This criterion was removed with Amendment 5.
. Participants with a history of Richter's syndrome are eligible if they now have evidence of CLL only, with \<10% large cells in the bone marrow.
. Participants must have adequate organ function, defined as creatinine ≤2.5 times the upper limit of normal range (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, and bilirubin ≤2.5 x ULN. For Cohorts 3 and 4, participants must have creatinine clearance ≥50 mL/min using modified Cockcroft-Gault equation (using Ideal Body Mass \[IBM\] instead of mass):
. IBM (kg) = \[(height cm - 154) ● 0.9\] + (50 if male, 45.5 if female).
. Platelets \>50 x 10\^9/L. In participants with CLL involvement of the marrow, \>30 x 10\^9/L for Cohorts 1 and 2. For Cohorts 3 and 4, participants must have hemoglobin \>9 g/dL.