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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Obinutuzumab for Chronic Lymphocytic Leukemia

Phase 2
Recruiting
Led By Jan A Burger
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis CLL/small lymphocytic lymphoma (SLL) and be untreated
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after completion of treatment
Awards & highlights

Study Summary

This trial is investigating whether a combination of two drugs, acalabrutinib and obinutuzumab, can effectively treat patients with chronic lymphocytic leukemia.

Who is the study for?
This trial is for patients with chronic lymphocytic leukemia (CLL) who haven't been treated before. They should have a creatinine clearance over 30 mL/min, normal liver function tests, and no prior malignancies within the last 2 years except certain skin cancers or 'in situ' carcinomas. Participants must be willing to use effective birth control and not be pregnant or breastfeeding. People with previous CLL treatments, significant infections, uncontrolled heart conditions, recent strokes or surgeries are excluded.Check my eligibility
What is being tested?
The trial is testing how well acalabrutinib combined with obinutuzumab works in treating CLL. Acalabrutinib blocks enzymes needed for tumor growth while obinutuzumab may help the immune system interfere with tumor cell growth and spread. The goal is to see if this combination can better manage disease progression in untreated CLL patients.See study design
What are the potential side effects?
Potential side effects include allergic reactions to medication components, issues swallowing pills due to gastrointestinal diseases that limit absorption of oral meds, bleeding disorders within the past three months, non-healing wounds or fractures, and complications from strong CYP3A4 inhibitors/inducers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with CLL/SLL and have not received any treatment.
Select...
I am able to care for myself and perform daily activities.
Select...
My condition requires treatment according to the 2018 IWCLL guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months after discontinuation of acalabrutinib, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after discontinuation of acalabrutinib, up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response rate
Treatment-free remission
Secondary outcome measures
Therapeutic procedure
Success rate of re-treatment in patients who relapse
Treatment-free remission length

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199
2%
Headache
1%
Chronic obstructive pulmonary disease
1%
Septic shock
1%
Ischaemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
BSC Alone
Acalabrutinib + BSC

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (acalabrutinib, obinutuzumab)Experimental Treatment2 Interventions
Patients receive acalabrutinib PO BID every 12 hours starting on day 1 of cycle 1, and obinutuzumab IV over 4-6 hours on days 1 and 2 of cycle 3, and day 1 of cycles 4-8. Patients who do not achieve a complete response or remission after cycle 8 may receive single-agent acalabrutinib therapy PO BID for an additional 6 cycles at the discretion of their treating physician. Patients who are in partial response or who have stable disease receive an additional 6 cycles of acalabrutinib PO BID and obinutuzumab IV. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,301 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,794 Total Patients Enrolled
Jan A BurgerPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
268 Total Patients Enrolled

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04505254 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (acalabrutinib, obinutuzumab)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04505254 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04505254 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants in this research project?

"Affirmative: the information listed on clinicaltrials.gov points to this trial actively recruiting participants, with a first posting date of August 25th 2020 and most recent update made on July 14th 2022. 60 patients are being sought from one medical centre."

Answered by AI

Is this experiment the inaugural attempt of its kind?

"Research into Acalabrutinib began in 2007, when Baxter Healthcare Corporation sponsored a clinical trial involving 4640 patients. Following the successful completion of this initial test, further trials were approved and 195 active experiments are being conducted across 55 nations and 1433 cities today."

Answered by AI

Is it feasible to be included in this scientific research at the present moment?

"Indeed, clinicaltrials.gov confirms that this research is actively recruiting participants since August 25th 2020. The last update was done on July 14th 2022 and the investigators are looking for 60 subjects to be enrolled from a single location."

Answered by AI

Has Acalabrutinib been granted governmental sanctioning for medical use?

"Based on the limited clinical data available, our team at Power assessed Acalabrutinib's safety rating as 2. As it is currently a Phase 2 medical trial, there is some evidence to support its security but none that corroborates efficacy."

Answered by AI

What other research has been undertaken to explore the benefits of Acalabrutinib?

"Presently, 195 Acalabrutinib-related experiments are being conducted; 30 of these live studies are in the third phase. The bulk of trials take place in Tampa, Florida yet a total of 13425 sites have been identified to test this drug."

Answered by AI

In what medical scenarios is Acalabrutinib typically prescribed?

"Acalabrutinib is a commonly prescribed treatment for refractory follicular lymphoma, and it may also prove advantageous in cases of renal dysfunction, chronic lymphocytic leukemia (CLL), and kidney failure."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia
2020. "Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04505254.
All > Cll > Chronic Lymphocytic Leukemia
~1 spots leftby Jun 2024
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