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Bruton Tyrosine Kinase Inhibitor
Acalabrutinib for Chronic Lymphocytic Leukemia
Phase 1 & 2
Waitlist Available
Research Sponsored by Acerta Pharma BV
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active disease meeting ≥ 1 of the following International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria for requiring treatment: Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL). Massive (i.e., ≥ 6 cm below the left costal margin), progressive, or symptomatic splenomegaly. Massive nodes (i.e., ≥ 10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy. Progressive lymphocytosis with an increase of > 50% over a 2-month period or a lymphocyte doubling time (LDT) of < 6 months. The LDT may be obtained by linear regression extrapolation of absolute lymphocyte counts (ALC) obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In participants with initial blood lymphocyte counts of < 30 X 10^9/L (30,000/μL), LDT should not be used as a single parameter to define indication for treatment. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL (eg, infections) should be excluded. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy. Constitutional symptoms documented in the participant's chart with supportive objective measures, as appropriate, defined as ≥ 1 of the following disease-related symptoms or signs: i. Unintentional weight loss ≥ 10% within the previous 6 months before screening. ii. Fevers higher than 100.5°F or 38.0°C for 2 or more weeks before screening without evidence of infection. iii. Night sweats for > 1 month before screening without evidence of infection. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. Agreement to use highly effective methods of contraception during the study and for 2 days after the last dose of study drug if sexually active and able to bear or beget children (see Section 3.7.9 for list of highly effective methods of contraception). Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules 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 participant privacy regulations).
Ibrutinib Intolerant only: Men and women ≥ 18 years of age with confirmed diagnosis of CLL/SLL who are not tolerating ibrutinib due to ibrutinib-related AEs.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on day 1 and day 8
Awards & highlights
Study Summary
This trial is testing a new drug to treat leukemia.
Who is the study for?
This trial is for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who need treatment, have specific symptoms like anemia or large spleen, and haven't responded well to other therapies. It's also for those intolerant to a drug called ibrutinib. People can't join if they've had certain recent treatments, uncontrolled heart issues, active infections like HIV/HBV/HCV, severe bleeding disorders, major surgery within the last month, or are pregnant.Check my eligibility
What is being tested?
The trial is testing Acalabrutinib's safety and effectiveness in treating CLL/SLL. Participants will take this new BTK inhibitor to see how it helps manage their leukemia compared to current standard treatments.See study design
What are the potential side effects?
Acalabrutinib may cause side effects such as headaches, diarrhea, muscle pain, reduced blood cell counts leading to increased infection risk or bruising/bleeding tendencies. Some people might experience more serious issues affecting the heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with CLL/SLL and cannot tolerate ibrutinib due to its side effects.
Select...
I have a lymph node larger than 2 cm due to my CLL/SLL.
Select...
I am 18 or older with a biopsy showing I have DLBCL from Richter's transformation or prolymphocytic leukemia.
Select...
I am 18 or older with CLL/SLL that didn't respond to at least 2 treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on day 1 and day 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on day 1 and day 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent Oral Clearance (CL/F) of Acalabrutinib
Apparent Volume of Distribution (Vz/F) of Acalabrutinib
Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Acalabrutinib
+11 moreSecondary outcome measures
Duration of Response (DOR) as Assessed by the Investigator
Percentage of Participants With Objective Response (OR) as Assessed by the Investigator
Progression Free Survival (PFS) as Assessed by the Investigator
Side effects data
From 2020 Phase 2 trial • 177 Patients • NCT043461992%
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
5Treatment groups
Experimental Treatment
Group I: Treatment-naive CohortExperimental Treatment1 Intervention
Treatment-naïve participants with confirmed CLL or SLL, will receive oral acalabrutinib Dose 5 QD (Cohort 7, later will be switched to Dose 1 BID per protocol amendment 6) or Dose 1 BID (Cohort 11) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Group II: Richters Syndrome/Prolymphocytic Leukemia Transformation CohortExperimental Treatment1 Intervention
Participants with diffuse large B-cell lymphoma (DLBCL) Richter's transformation (RS) or prolymphocytic leukemia (PLL) transformation, will receive oral acalabrutinib Dose 5 BID (Cohort 9) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Group III: Relapsed/Refractory CohortExperimental Treatment1 Intervention
Phase 1 (dose-escalation) and Phase 2 (dose-expansion) will be conducted for participants with relapsed/refractory CLL or SLL. In Phase 1, participants will receive oral once daily (QD) acalabrutinib at Dose 1 (Cohort 1), Dose 2 (Cohort 2a), Dose 3 (Cohort 3), and Dose 4 (Cohort 4a), and twice daily (BID) acalabrutinib at Dose 1 (Cohort 2b) and Dose 5 (Cohort 4b) for 28 days (1 cycle). In Phase 2, participants will receive oral acalabrutinib at Dose 1 BID (Cohort 2b) or Dose 5 QD (Cohort 2c, later will be switched to Dose 1 BID per protocol amendment 6) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest. Participants from Phase 1 will be continued to receive Dose 1 BID until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Group IV: Ibrutinib-intolerant CohortExperimental Treatment1 Intervention
Participants with confirmed CLL or SLL and were not tolerating ibrutinib treatment, will receive oral acalabrutinib Dose 5 QD (Cohort 8a, later switched to Dose 1 BID per protocol amendment 4) or Dose 1 BID (Cohort 8b) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Group V: Ibrutinib Relapsed/Refractory CohortExperimental Treatment1 Intervention
Participants with confirmed CLL/SLL and had relapsed/refractory to ibrutinib treatment, will receive oral acalabrutinib Dose 5 QD (Cohort 10) until disease progression or until the investigator will consider the study treatment to be intolerable or no longer in the participant's best interest.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acalabrutinib
2020
Completed Phase 2
~2050
Find a Location
Who is running the clinical trial?
Acerta Pharma BVLead Sponsor
45 Previous Clinical Trials
5,619 Total Patients Enrolled
Acerta Clinical TrialsStudy Director1-888-292-9613 acertamc@dlss.com
17 Previous Clinical Trials
2,120 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older with CLL/SLL and cannot tolerate ibrutinib due to its side effects.I am 18 or older with CLL/SLL and need treatment but can't or don't want to undergo chemoimmunotherapy.I do not have active HIV, hepatitis B, or C, or any uncontrolled infection.I am 18 or older with CLL/SLL that didn't improve or got worse after ibrutinib treatment.I do not have uncontrolled AIHA or ITP requiring high doses of steroids.I have a lymph node larger than 2 cm due to my CLL/SLL.I have had cancer before, but it was either skin cancer treated successfully, cervical cancer that did not spread, or any cancer from which I've been free for 2+ years.I do not have serious heart problems like recent heart attacks or severe heart failure.I need medication for stomach acid, like omeprazole.My liver function tests are within the allowed range for my condition.I do not have a severe illness that could risk my safety in the study.I do not have significant gastrointestinal issues or surgeries affecting digestion.I haven't had immunotherapy in the last 4 weeks.I have waited long enough after my last chemotherapy or experimental therapy to start the study drug.My condition did not improve after BTK inhibitor therapy.I am experiencing side effects from cancer treatment, excluding hair loss.I have a bleeding disorder such as hemophilia or von Willebrand disease.I have not had major surgery in the last 4 weeks.My kidneys are not functioning well, with a creatinine clearance of less than 30 mL/min.I am 18 or older with a biopsy showing I have DLBCL from Richter's transformation or prolymphocytic leukemia.My lymphoma has spread to my brain or spinal cord.I am 18 or older with CLL/SLL that didn't respond to at least 2 treatments.I need warfarin or a similar drug for blood thinning within 7 days of starting the study drug.I have never had Richter's transformation.You are currently participating in another clinical trial for a different treatment.My heart's electrical activity is normal, without specific severe issues.I have not had a stroke or brain bleed in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Richters Syndrome/Prolymphocytic Leukemia Transformation Cohort
- Group 2: Ibrutinib-intolerant Cohort
- Group 3: Ibrutinib Relapsed/Refractory Cohort
- Group 4: Relapsed/Refractory Cohort
- Group 5: Treatment-naive Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment only test on individuals over a certain age?
"Eligibility requirements for this study include being over 18 but under 130 years old."
Answered by AI
Are people currently being accepted into this trial?
"This specific trial, as evidenced by clinicaltrials.gov, is not currently looking for more patients. The study was originally posted on 1/30/2014 and was last edited on 8/17/2022. However, there are 2939 other trials that are actively recruiting right now."
Answered by AI
Has a similar experiment been conducted previously?
"Acalabrutinib has been under investigation since 2014 when it was first studied by Acerta Pharma BV. The Phase 1 & 2 drug approval followed the initial study in 306 patients. Currently, there are 76 active studies being conducted for acalabrutinib across 504 cities and 47 countries."
Answered by AI
What illnesses has acalabrutinib been tested on?
"Acalabrutinib is an effective treatment for mantle cell lymphoma, small lymphocytic lymphoma, and chronic lymphocytic leukemia."
Answered by AI
For which patient population is this research applicable?
"This trial is recruiting 306 patients with leukemia, lymphoid aged 18 and 130. Most importantly, applicants must meet the following criteria: -Men and women ≥ 18 years of age with a confirmed diagnosis of CLL/SLL, which has relapsed after, or been refractory to, ≥ 2 previous treatments for CLL/SLL.-Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia (platelets < 100,000/μL).-Progressive"
Answered by AI
How many different medical facilities are conducting this research project?
"Currently, this trial is taking place at 9 clinics. 8 of these locations are in New Hyde Park, New york and Tacoma. The other location is TBD, so please select the closest clinic to minimize travel burdens if you enroll."
Answered by AI
Do we have any historical evidence to support the efficacy of acalabrutinib?
"Acalabrutinib was first studied in 2014 and there have been 24 completed clinical trials thus far. Currently, there are 76 live studies being conducted with many of them based out of New Hyde Park, New york."
Answered by AI
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