Acalabrutinib for Lymphocytic Leukemia/Lymphoma

Phase-Based Progress Estimates
Research Site, Charlotte, NCLymphocytic Leukemia/LymphomaAcalabrutinib - Drug
18 - 130
All Sexes
What conditions do you have?

Study Summary

This trial compared two different treatment regimens for people with previously untreated CLL or SLL.

Eligible Conditions
  • Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Date of randomization until PD (Assessed Up to 6.6 Years)

Year 6
Rate of peripheral blood (PB) and Bone marrow (BM) undetectable minimal residual disease (uMRD) by flow cytometry
Year 6
Complete Response (CR) rate
Overall Response Rate (ORR)
Year 6
Overall Survival (OS)
Year 6
Event-free Survival (EFS)
Year 6
Proportion of participants reporting each response option of the Patient Global Impression of Benefit-Risk (PGI-BR)
Year 6
Change from baseline in EORTC QLQ-CLL17 scales
Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 scales
Proportion of participants experiencing bruising as measured by the National Cancer Institute (NCI) Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) item for Bruising
Year 6
Number of participants with adverse events (AEs)
Day 28
Rate of peripheral blood (PB) undetectable minimal residual disease (uMRD) based on a clonoSEQ^®
Year 6
Progression-free Survival (PFS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

BSC Alone
1%Septic shock
1%Ischaemic stroke
1%Chronic obstructive pulmonary disease
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT04346199) in the BSC Alone ARM group. Side effects include: Headache with 2%, Septic shock with 1%, Ischaemic stroke with 1%, Chronic obstructive pulmonary disease with 1%.

Trial Design

2 Treatment Groups

Arm A: Acalabrutinib plus Venetoclax (AV)
1 of 2
Arm B: Venetoclax plus Obinutuzumab (VO)
1 of 2

Experimental Treatment

600 Total Participants · 2 Treatment Groups

Primary Treatment: Acalabrutinib · No Placebo Group · Phase 3

Arm A: Acalabrutinib plus Venetoclax (AV)Experimental Group · 2 Interventions: Acalabrutinib, Venetoclax · Intervention Types: Drug, Drug
Arm B: Venetoclax plus Obinutuzumab (VO)Experimental Group · 2 Interventions: Obinutuzumab, Venetoclax · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
FDA approved
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: date of randomization until pd (assessed up to 6.6 years)

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,021 Previous Clinical Trials
240,380,854 Total Patients Enrolled

Eligibility Criteria

Age 18 - 130 · All Participants · 11 Total Inclusion Criteria

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Frequently Asked Questions

What autoimmune diseases does Acalabrutinib typically help to manage?

"Acalabrutinib is frequently used to treat small lymphocytic lymphoma. However, it can also ameliorate symptoms for patients suffering from lymphoid leukemia, ≥ 1 prior therapy for mantle cell lymphoma, and refractory follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

How can I become a subject in this experiment?

"This study is seeking 600 participants with lymphoma who are aged 18 or older. Candidates should meet the following criteria: 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)., Participant must be ≥ 18 years at the time of screening., Documented TN CLL/SLL requiring treatment according to iwCLL guidelines 2018 (Hallek et al 2018)., Absolute neutrophil count ≥ 1.0 × 10 9 /L., Platelet counts ≥ 30 × 10 9 /L; in" - Anonymous Online Contributor

Unverified Answer

What other research has been conducted with Acalabrutinib?

"Acalabrutinib was first studied in 2012 at CHU de Dijon. As of now, there have been 123 completed trials with 350 more currently underway. The majority of these active studies are taking place in Jacksonville, Florida." - Anonymous Online Contributor

Unverified Answer

In how many different medical clinics is this medical study being run today?

"There are 17 locations currently enrolling patients for this study, with participating clinics located in Jacksonville, Longmont, Buffalo and 14 other cities. To minimize potential travel requirements, it is recommended that you select the clinic nearest to your location." - Anonymous Online Contributor

Unverified Answer

Could you list some of the potential Acalabrutinib side effects?

"Acalabrutinib's safety is well-documented, as this drug has reached Phase 3 in clinical trials." - Anonymous Online Contributor

Unverified Answer

Is this research study open to elderly participants?

"This particular study is looking for clinical trial participants that are aged 18-130. Out of the 3,544 total trials, 655 focus on children and 2889 involve senior citizens." - Anonymous Online Contributor

Unverified Answer

How many individuals are allowed to participate in this experiment?

"That is correct. The clinical trial in question, which was posted on September 12th, 2022 and edited October 3rd, 2022 according to information available on, is currently recruiting 600 patients from 17 different locations." - Anonymous Online Contributor

Unverified Answer

Are researchers still looking for participants in this trial?

"Yes, this is an active trial according to the information provided on The listing for the study says that it was posted on 9/12/2022 and last updated on 10/3/2022. They are looking for 600 patients total from 17 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.