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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05057494
Registration number
NCT05057494
Ethics application status
Date submitted
16/09/2021
Date registered
27/09/2021
Date last updated
16/04/2024
Titles & IDs
Public title
A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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Scientific title
A Phase III Prospective, Multicenter, Randomized, Open-Label Trial of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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Secondary ID [1]
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2021-003936-10
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Secondary ID [2]
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D8220C00027
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Universal Trial Number (UTN)
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Trial acronym
MAJIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Acalabrutinib
Treatment: Drugs - Venetoclax
Treatment: Drugs - Obinutuzumab
Experimental: Arm A: Acalabrutinib plus Venetoclax (AV) - Participants will receive acalabrutinib and venetoclax orally.
Experimental: Arm B: Venetoclax plus Obinutuzumab (VO) - Participants will receive Venetoclax orally and Obinutuzumab via IV infusion.
Treatment: Drugs: Acalabrutinib
Dose formulation: Capsule or Tablet
Treatment: Drugs: Venetoclax
Dose formulation: Tablet
Treatment: Drugs: Obinutuzumab
Dose formulation: Injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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To assess whether minimal residual disease (MRD)-driven finite AV treatment is NI to MRD-driven finite VO treatment with respect to PFS. PFS is defined as the time from the date of randomization until date of objective progressive disease per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria as assessed by the investigator or death from any cause in the absence of progression.
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Timepoint [1]
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Until progressive disease (PD) [assessed Up to 6.6 Years].
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Secondary outcome [1]
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Rate of peripheral blood (PB) undetectable minimal residual disease (uMRD) based on a clonoSEQ^®
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Assessment method [1]
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To assess the effect of AV treatment compared with VO treatment on uMRD at sequential time points. Rate of PB uMRD is defined as proportion of participants achieving remission based on a clonoSEQ^® assay result of < 1 CLL cell per 100,000 leukocytes (< 10 ^-5 ), after completion of 6 and 12 cycles of venetoclax (assessed at approximately 7/13 and 9/15 months for VO and AV, respectively), and at 24, 36, 48 and 60 months.
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Timepoint [1]
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Screening (Days -45 through -1); Arm A (AV): Day 28 of Cycles 8, 14 and 24 and post treatment follow up visits; Arm B (VO): Day 28 of Cycles 6, 12 and 24 and post treatment follow up visits
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Secondary outcome [2]
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Rate of peripheral blood (PB) and Bone marrow (BM) undetectable minimal residual disease (uMRD) by flow cytometry
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Assessment method [2]
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To assess the effect of AV treatment compared with VO treatment on uMRD at sequential timepoints. Rate of PB and BM uMRD is defined as < 1 CLL cell per 10,000 leukocytes (< 10^-4) by flow cytometry, after completion of 12 cycles of venetoclax (assessed at approximately 13 and 15 months for VO and AV, respectively) and at 36 months.
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Timepoint [2]
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Cycle 14 (each Cycle length 28 days) Day 28 for Arm A (AV); Cycle 12 Day 28 for Arm B (VO) and Post treatment follow-up visits (assessed Up to 6.6 Years)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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To assess the effect of AV treatment compared with VO treatment on OS. OS is defined as the time from the date of randomization until death from any cause.
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Timepoint [3]
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Date of randomization until death from any cause (Assessed Up to 6.6 Years)
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Secondary outcome [4]
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Event-free Survival (EFS)
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Assessment method [4]
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To assess the effect of AV treatment compared with VO treatment on EFS. EFS is defined as the time from the date of randomization to the first occurrence of disease progression, initiation of subsequent CLL therapy, or death from any cause.
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Timepoint [4]
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Date of randomization until first occurrence of disease progression (Assessed Up to 6.6 Years)
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Secondary outcome [5]
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Overall Response Rate (ORR)
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Assessment method [5]
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To assess the effect of AV treatment compared with VO treatment on ORR. ORR is defined as the proportion of participants who achieve best response of Complete Response (CR), complete response with incomplete marrow recovery (Cri), nodular partial remission (nPR), or partial remission (PR) per iwCLL 2018 criteria as assessed by the investigator.
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Timepoint [5]
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Date of randomization until PD (Assessed Up to 6.6 Years)
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Secondary outcome [6]
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Complete Response (CR) rate
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Assessment method [6]
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To assess the effect of AV treatment compared with VO treatment on ORR. CR rate (uMRD per iwCLL guidelines 2018) after completion of 12 cycles of venetoclax.
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Timepoint [6]
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Date of randomization until PD (Assessed Up to 6.6 Years)
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Secondary outcome [7]
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Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 scales
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Assessment method [7]
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To assess symptoms, functional status and global health status/quality of life (QoL), in participants treated with AV versus VO using the EORTC QLQ-C30.
EORTC QLQ-C30 consists of 30 items and measures symptoms, functioning, and global health status/QoL for all cancer types. Questions are grouped into 5 multi-item functional scales, 3 multi-item symptom scales, a 2-item global QoL scale, 5 single items assessing additional symptoms commonly reported by cancer participants, and 1 item on the financial impact of the disease.
The EORTC QLQ-C30 will be scored according to the EORTC QLQ-C30 Scoring Manual. An outcome variable consisting of a score from 0 to 100 will be derived for each of the symptom scales, each of the functional scales, and the global measure of health status scale. Higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.
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Timepoint [7]
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For AV: Cycle 1-Cycle 2, Cycle 3-Cycle 14; After End of Treatment (EoT); Post treatment follow-up For VO: Cycle 1 Day 1-21, Cycle 1 Day 22-Cycle 6, Cycle 7-Cycle 24 (Each cycle is 28 days); After EoT, Post treatment follow-up (assessed Up to 6.6 years)
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Secondary outcome [8]
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Change from baseline in EORTC QLQ-CLL17 scales
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Assessment method [8]
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To assess symptoms, functional status, and global health status/QoL, participants treated with AV versus VO using the EORTC QLQ-CLL17.
EORTC QLQ-CLL17 comprises 17 items grouped into 3 multi-item scales: 1) symptom burden, 2) physical condition/fatigue, and 3) worries/fears about health and functioning.
The EORTC QLQ-CLL17 will be scored according to the EORTC QLQ-C30 Scoring Manual. An outcome variable consisting of a score from 0 to 100 will be derived for each of the symptom scales, each of the functional scales, and the global measure of health status scale. Higher scores on the global measure of health status and functional scales indicate better health status/function, but higher scores on symptom scales represent greater symptom severity.
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Timepoint [8]
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For AV: Cycle 1-Cycle 2, Cycle 3-Cycle 14; After End of Treatment (EoT); Post treatment follow-up For VO: Cycle 1 Day 1-21, Cycle 1 Day 22-Cycle 6, Cycle 7-Cycle 24 (Each cycle is 28 days); After EoT, Post treatment follow-up (assessed Up to 6.6 years)
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Secondary outcome [9]
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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
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Assessment method [9]
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To assess symptomatic toxicities patient perceived benefit-risk in participants treated with AV versus VO using the NCI PRO-CTCAE item for Bruising.
It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE), the standard lexicon for adverse event reporting in cancer trials. The bruising item, which has a dichotomous yes/no response option, will be included in this study to capture patient-reported bruising.
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Timepoint [9]
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For AV: Cycle 1-Cycle 2, Cycle 3-Cycle 14; After End of Treatment (EoT); Post treatment follow-up For VO: Cycle 1 Day 1-21, Cycle 1 Day 22-Cycle 6, Cycle 7-Cycle 24 (Each cycle is 28 days); After EoT, Post treatment follow-up (assessed Up to 6.6 years)
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Secondary outcome [10]
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Proportion of participants reporting each response option of the Patient Global Impression of Benefit-Risk (PGI-BR)
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Assessment method [10]
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To assess patient perceived benefit-risk of treatment in participants treated with AV versus VO using the PGI-BR.
PGI-BR consists of 4 study medication-related questions, one each on efficacy, side effects, convenience of use, and overall benefit-risk. Each item is scored separately, with the final item providing a single metric of a participant's overall benefit-risk assessment.
The response from each question will be semi-quantitative. Each question ranges from Very (negative, Somewhat [negative]), Neutral, Somewhat [positive], Very [positive].
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Timepoint [10]
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For AV: Cycle 1-Cycle 2, Cycle 3-Cycle 14 (Each cycle is 28 days); and End of treatment, E/D, disease progression, and post-treatment follow-up visits (assessed up to 6.6 years)
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Secondary outcome [11]
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Number of participants with adverse events (AEs)
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Assessment method [11]
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To assess the safety and tolerability of AV treatment versus VO treatment in participants with previously untreated CLL/SLL.
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Timepoint [11]
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From screening (Days -45 through -1) until survival follow-up (Up to 6.6 years)
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Eligibility
Key inclusion criteria
1. Participant must be = 18 years at the time of signing the consent form.
2. Documented TN CLL/SLL requiring treatment according to iwCLL guidelines 2018 (Hallek
et al 2018).
3. Adequate BM function independent of growth factor or platelet transfusion support
within 2 weeks of screening initiation as follows:
1. Absolute neutrophil count = 1.0 × 10 9 /L; absolute neutrophil count = 500
cells/µL (= 0.50 × 109/L) with documented bone marrow (BM) involvement of chronic
lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL).
2. Platelet counts = 30 × 10 9 /L; platelet count = 10 × 10 9 /L in participants
with documented BM involvement of CLL/SLL.
4. Estimated CrCL of = 30 mL/min calculated by Cockcroft-Gault (using actual body weight)
or serum creatinine < 2 × ULN,
Males:
CrCL (mL/min) = Weight (kg) × (140 - Age)/72 × serum creatinine (mg/dL)
Females:
CrCL (mL/min) = Weight (kg) × (140 - Age) × 0.85/72 × serum creatinine (mg/dL)
5. Meet the following laboratory parameters (Upper limit of normal (ULN) is based on
institutional standards):
1. Serum AST and ALT = 3 × ULN (Higher thresholds may be allowed if hepatic
dysfunction is attributable to CLL/SLL and after discussion with the Sponsor
Hematology Safety Knowledge Group).
2. Total bilirubin = 1.5 × ULN, unless directly attributable to Gilbert's syndrome.
6. An ECOG (Eastern Cooperative Oncology Group) performance status performance status of
0 to 2 with no deterioration over the previous 2 weeks prior to baseline or day of
first dosing.
7. 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).
8. Willing and able to participate in all required evaluations and procedures in this
study protocol including swallowing capsules and tablets without difficulty.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. As judged by the investigator, any evidence of past or current diseases that, in the
investigator's opinion, makes it undesirable for the participant to participate in the
study or that would jeopardize their safety or compliance with the protocol or would
put the study at risk.
2. Clinically significant cardiovascular disease, such as 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. Note: Participants with controlled, asymptomatic atrial
fibrillation can enroll in the study.
3. Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand
disease).
4. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.
5. History of significant cerebrovascular disease/event, including stroke or intracranial
hemorrhage, within 6 months before the first dose of study intervention.
6. Child-Pugh B/C liver cirrhosis.
7. History of prior or current malignancy (including but not limited to known central
nervous system involvement such as by CLL/SLL, leptomeningeal disease, or spinal cord
compression, known prolymphocytic leukemia or history of, or currently suspected,
Richter's syndrome) that could affect compliance with the protocol or interpretation
of results. Possible examples where compliance or data interpretation may not be
affected could include the following, per physician discretion.
1. Curatively treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of
the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate
at any time prior to study.
2. Other cancers that have been curatively treated from which the participant is
disease-free for = 3 years without further treatment.
8. An individual organ system dysfunction limiting the ability to receive the study
intervention or any other life-threatening illness, medical condition, or organ system
dysfunction that, in the investigator's opinion, could compromise the participants'
safety or interfere with the absorption, distribution, metabolism, or excretion of the
study interventions (eg, refractory nausea and vomiting, chronic gastrointestinal
disease, inability to swallow the formulated product, previous significant bowel
resection, or impaired resorption in the gastrointestinal tract).
9. Known history of infection with HIV or any active significant infection (eg,
bacterial, viral, or fungal; including participants with positive cytomegalovirus
(CMV) DNA PCR). CMV testing at screening must include serologic testing for CMV
immunoglobulin G (CMV IgG), CMV immunoglobulin M (CMV IgM), and CMV DNA PCR testing.
Participants must have a result for CMV DNA PCR that is negative at screening to be
eligible for the study.
10. History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML).
11. Serologic status reflecting active hepatitis B or C infection:
1. Hepatitis serology will include HBsAg, anti-HBs, anti-HBc and anti-HCV. Any
participant who is both anti-HBc positive and HBsAg negative will need to have a
negative HBV DNA PCR result before randomization and must be willing to undergo
this PCR testing during the study. Any participant who is either HBsAg positive
or hepatitis B DNA PCR positive will be excluded.
2. Participants who are hepatitis C antibody positive or inconclusive will need to
have a negative HCV RNA PCR result before randomization. Those who are hepatitis
C PCR positive will be excluded.
12. Any prior CLL/SLL-specific therapies, except prior rituximab if used for autoimmune
cytopenias and not as anti-CLL/SLL treatment.
13. Corticosteroid use > 20 mg within 1 week before the first dose of study intervention,
except as indicated for other medical conditions, such as autoimmune cytopenias,
inhaled steroid for asthma, topical steroid use, or as premedication for
administration of study intervention or contrast. Participants requiring steroids at
daily doses > 20 mg prednisone equivalent systemic exposure daily, or those who are
administered steroids for leukemia control or white blood cell count lowering, are
excluded. Of note, participants may receive corticosteroids as doses > 20 mg as per
institutional standards for obinutuzumab premedication prior to C1D1.
14. Prior radio- or toxin-conjugated antibody therapy.
15. Prior allogeneic stem cell or autologous transplant.
16. Known history of hypersensitivity or anaphylaxis to study intervention(s), including
active product or excipient components.
17. Requires treatment with a strong cytochrome CYP3A4 inhibitor/inducer. The use of
strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the
first dose of study drug is prohibited.
18. Requires or receiving anticoagulation with warfarin or equivalent vitamin K
antagonists (other anticoagulants allowed).
19. Requires treatment with proton pump inhibitors (PPIs) (eg, omeprazole, esomeprazole,
lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Participants
receiving PPIs who switch to H2-receptor antagonists or antacids are eligible for
enrollment to this study. This criterion applies only to participants receiving
acalabrutinib capsules. This PPI exclusion does not apply if the participant is
receiving acalabrutinib tablets.
20. Vaccination with live vaccines 28 days prior to registration for study screening.
21. Major surgical procedure within 28 days of first dose of study intervention. Note: If
a participant had major surgery, they must have recovered adequately from any toxicity
and/or complications from the intervention before the first dose of study
intervention.
22. Concurrent participation in another therapeutic clinical trial. Use of investigational
agents that interfere with the study intervention(s) within 28 days or 5 half-lives
(whichever is longer) prior to registration for study screening.
23. Prothrombin time/INR or activated partial thromboplastin time, in the absence of lupus
anticoagulant or attributed to anticoagulant (eg, direct oral anticoagulant), > 2 ×
ULN.
24. Currently pregnant (confirmed with positive pregnancy test) or breast feeding.
25. Women of childbearing Potential (WOCBP) unless the following criteria are met: A
negative pregnancy test at least 30 days before start of study intervention, followed
by immediate highly effective contraception; further pregnancy testing will be
performed monthly.
26. Fertile men or WOCBP unless the following criteria are met: Willing to use 2 methods
of reliable contraception, including one highly effective contraceptive method (Pearl
Index < 1) and one additional effective (barrier) method during study intervention and
for 2 days after last acalabrutinib dose (for WOCBP), 30 days after last venetoclax
dose (fertile men and WOCBP), and 6 months after last obinutuzumab dose for fertile
men and 18 months after last obinutuzumab dose for WOCBP.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
10/04/2029
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Actual
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Sample size
Target
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Accrual to date
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Final
607
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Clayton
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Research Site - Geelong
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Recruitment hospital [3]
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Research Site - Nedlands
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Recruitment hospital [4]
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Research Site - Waratah
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3220 - Geelong
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment postcode(s) [4]
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2298 - Waratah
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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California
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Colorado
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Florida
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Maryland
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Massachusetts
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Missouri
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New York
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North Carolina
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Ohio
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Oregon
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Tennessee
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Utah
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Washington
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Czechia
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Hradec Kralove
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Czechia
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Ostrava - Poruba
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Czechia
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Pilsen
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France
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Bobigny Cedex
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France
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Montpellier Cedex 5
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France
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Tours
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Hungary
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Budapest
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Hungary
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Debrecen
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Bydgoszcz
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Gdansk
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Katowice
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Kraków
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Lublin
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Lódz
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Spain
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Barcelona
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Spain
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Palma de Mallorca
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
A study of acalabrutinib plus venetoclax (AV) versus venetoclax plus obinutuzumab (VO) in
previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05057494
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05057494
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