Chronic Lymphocytic Leukemia and Relapsed and Refractory Mantle Cell LymphomaPhase 4NCT04930536
Acalabrutinib Study in Indian Patients With Chronic Lymphocytic Leukaemia & Relapsed and Refractory Mantle Cell Lymphoma
A Phase 4 study testing Acalabrutinib capsule in people with Chronic Lymphocytic Leukemia and Relapsed and Refractory Mantle Cell Lymphoma, run by AstraZeneca at 15 sites in India.
Trial summary
This study is plan to assess the safety and efficacy of Acalabrutinib in Indian patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Lymphocytic Leukemia and Relapsed and Refractory Mantle Cell Lymphoma
- What is being tested?
- Acalabrutinib capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 15 sitesIndia
- Study dates
- 14 Jul 2021to 2 May 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply:
- 1. Men and Women aged 18yrs or more. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2 3. Able to receive all outpatient treatments, all laboratory monitoring, and all radiologic evaluations.
- 4. The following laboratory parameters:
- Absolute neutrophil count (ANC) ≥750 cells/μL or ≥500 cells/μL in patients with documented bone marrow involvement, and independent of growth factor support 07 days before the assessment
- Platelet count ≥50,000 cells/μL or ≥30,000 cells/μL in patients with documented bone marrow involvement, and without transfusion support 07 days before the assessment
- Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤2.0 x ULN
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- Total bilirubin ≤1.5 x ULN
- Estimated creatinine clearance of ≥30 mL/min 5. Refractory disease defined as achieving less than partial response with the most recent treatment within 6 months before study entry 6. Provision of signed, written and dated informed consent prior to any study-specific Procedures 7. The patients of either CLL or MCL:
- CLL patients: i. Treatment naïve or ≥1 prior systemic therapy for CLL ii. Diagnosis of CD20+ CLL that meets published diagnostic criteria (Hallek et al. 2018) iii. An active disease that meets ≥1 of the following iwCLL 2018 criteria for requiring treatment:
- Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia. Cut-off levels of Hb <10 g/dL or platelet counts <100 × 109/L are generally regarded as an indication for treatment. However, in some patients, platelet counts <100 × 109/L may remain stable over a long period; this situation does not automatically require therapeutic intervention.
- Massive (i.e., ≥6 cm below the left costal margin) or progressive or symptomatic splenomegaly.
- Massive nodes (i.e., ≥10 cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- Progressive lymphocytosis with an increase of ≥50% over a 2-month period or Lymphocyte Doubling Time (LDT) in <6 months. LDT can be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months; patients with initial blood lymphocyte counts <30 × 109/L may require a longer observation period to determine the LDT. Factors contributing to lymphocytosis other than CLL (e.g., infections, steroid administration) should be excluded.
- Autoimmune complications, including anaemia or thrombocytopenia poorly responsive to corticosteroids.
- Symptomatic or functional extra-nodal involvement (e.g., skin, kidney, lung, spine).
- Disease-related symptoms as defined by any of the following:
- Unintentional weight loss of ≥10% within the previous 06 months.
- Significant fatigue (i.e., ECOG performance scale 02 or worse; cannot work or unable to perform usual activities).
- Fever ≥100.5°F or 38.0°C for 02 or more weeks without evidence of infection.
- Night sweats for ≥1 month without evidence of infection.
- MCL Patients: i. Confirmed MCL with translocation t(11;14) (q13;q32) and/or overexpressed cyclin D1 ii. Measurable nodal disease (one or more lesions measuring ≥2 cm in the longest diameter) iii. Relapsed after, or were refractory to, 1-5 previous treatments
Who cannot join
- Known prolymphocytic leukaemia, Central Nervous System (CNS) lymphoma or leukaemia; or known history of (or currently suspected) Richter's syndrome
- Treatment with chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days of the first dose of study drug
- Prior radio-conjugated or toxin-conjugated antibody therapy
- Anticoagulation therapy (e.g., warfarin or equivalent vitamin K antagonists) within 07 days of the first dose of study drug.
- Major surgery ≤30 days before the first dose of study drug
- History of stroke or intracranial haemorrhage ≤6 months before the first dose of study drug
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- History of bleeding diathesis
- Prior exposure to a B-cell lymphoma-2 (Bcl-2) inhibitor or B-cell receptor inhibitor like BTKs
- Active Cytomegalovirus (CMV) infection or serologic status reflecting active Hepatitis B or C infection or known history of infection with Human Immunodeficiency Virus (HIV), or any uncontrolled active systemic infection.
- Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, Congestive Heart Failure, or Myocardial Infarction within 06 months of screening, or any Class 3 or 4 cardiac diseases as defined by the New York Heart Association Functional Classification, or QTcB >480 msec at screening.
- Requiring treatment with proton-pump inhibitors (e.g., Omeprazole, Esomeprazole, Lansoprazole, Dexlansoprazole, Rabeprazole, or Pantoprazole).
- Breastfeeding or pregnant.
- Current life-threatening illness, medical condition, or organ/system dysfunction which, in the Investigator's opinion, could have compromised the subject's safety or put the study at risk.
- Concurrent participation in another therapeutic clinical trial.
- -
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
India15 sites
Research Site
Ahmedabad, 380009
Research Site
Bangalore, 560017
Research Site
Bangalore, 560064
Research Site
Bengaluru, 560099
Research Site
Chandigarh, 160012
Research Site
Gurugram, 122001
Research Site
Guwahati, 781032
Research Site
Hyderabad, 500019
Research Site
Hyderabad, 500033
Research Site
Kochi, 682041
Research Site
Kolkata, 700160
Research Site
Ludhiana, 141 008
Research Site
Mumbai, 400010
Research Site
Mumbai, 400012
Research Site
New Delhi, 110 085
About this study
Official title: A Prospective, Multi-centre, Phase IV Clinical Trial to Assess the Safety and Efficacy of Acalabrutinib Capsules in Indian Adult Patients With Chronic Lymphocytic Leukaemia and Relapsed and Refractory Mantle Cell Lymphoma.
This study is plan to assess the safety and efficacy of Acalabrutinib in Indian patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL)
Read the detailed description
A prospective, multi-centre, phase IV clinical trial of Acalabrutinib capsules in Indian adult patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL). As per recommendation from Indian health authority, the current phase-IV study is planned with the aim to assess the safety and efficacy profile of Acalabrutinib in Indian patients with CLL/SLL, and patients with MCL who have received at least one prior therapy. The data obtained from the study will help to understand the safety and efficacy profile of Acalabrutinib in Indian patients. Patients will be monitored throughout the study period for Adverse Events of Acalabrutinib
- Being tested
- Acalabrutinib capsule
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Recurrence, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acalabrutinib capsuleDrug
Also called Calquence®
The recommended dose of Acalabrutinib is 100 mg given per oral (PO) twice daily
| Study group | Role | What they receive |
|---|---|---|
| Acalabrutinib Capsule | Experimental | Single-arm study Receives: Drug: Acalabrutinib capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events of Special Interest (AESI) Including Arrhythmias (Atrial Fibrillation), Anaemia, Hypertension, Bleeding, Infections
The AESIs for acalabrutinib, including arrhythmias (atrial fibrillation), anaemia, hypertension, bleeding, and infections, are presented.
Measured: Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
Second Primary Malignancies
The safety of acalabrutinib was investigated by determining the number of second primary malignancies.
Measured: Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
Secondary outcomes (2)
Objective Response to Treatment
The efficacy of acalabrutinib was assessed by measuring the participants' objective response to treatment.
Objective response = Complete Response (CR) + Partial Response (PR) + Partial Response with lymphocytosis (PRL).
Measured: Visit 5 (Day 85) and Visit 8 (Day 170)
Health Related Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQC30] Questionnaire)
The EORTC QLQ-C30 is a 30-item questionnaire that measures quality of life in cancer patients. It is divided into several scales: Functioning Scales (Physical, Role, Cognitive, Emotional, and Social), Symptom Scales (Fatigue, Pain, Nausea/Vomiting), Dyspnoea, Sleep Disturbances, Appetite Loss, Diarrhoea, Constipation, Financial Difficulties, and Global Health Status/Quality of Life Scale. Scores range from 0 to 100. A higher score indicates better health related quality of life.
The total scores were calculated from the mean of the 13 QLQ-C30 scales (Global Quality of Life Scale and Financial Impact Scale were excluded). Prior to calculating the mean, Symptom Scales were reversed to obtain a uniform direction of all scales. The total score was only calculated if all of the required 13 scale scores were available using scale scores based on the completed items, provided that at least 50% of the items in that scale were completed.
Measured: From Visit 1 (Day 0), during Visit 5 (Day 85), and at Visit 8 (Day 170)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start14 Jul 2021
- Primary completion2 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Lymphocytic Leukemia and Relapsed and Refractory Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Prospective, Multicentre, Phase-IV study and Clinical trials with a single arm.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930536
- Sponsor's protocol ID
- D8220C00022
- Status last verified
- Oct 2024
- First submitted
- 11 Jun 2021
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Publications
Malhotra P, Bhurani D, Sengar M, Sood N, Nag A, Aribandi A, George B, Menon H, Bhattacharyya J, Kalashetty M, Agrawal N, Sidharthan N, Ahmed R, Shah S, Bhave S, Damodar S. A prospective, multi-center, phase IV clinical study to assess the safety and clinical outcome of acalabrutinib in Indian adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma or relapsed/refractory mantle cell lymphoma. Front Oncol. 2026 Sep 10;16:1822178. doi: 10.3389/fonc.2026.1822178. eCollection 2026.
PubMed 42787222
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre, Phase IV Clinical Trial to Assess the Safety and Efficacy of Acalabrutinib Capsules in Indian Adult Patients With Chronic Lymphocytic Leukaemia and Relapsed and Refractory Mantle Cell Lymphoma.
- ClinicalTrials.gov ID
- NCT04930536
- Acronym / sponsor ID
- D8220C00022
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 2 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is plan to assess the safety and efficacy of Acalabrutinib in Indian patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL)
Detailed description
A prospective, multi-centre, phase IV clinical trial of Acalabrutinib capsules in Indian adult patients with chronic lymphocytic leukaemia (CLL) and relapsed and refractory mantle cell lymphoma (MCL). As per recommendation from Indian health authority, the current phase-IV study is planned with the aim to assess the safety and efficacy profile of Acalabrutinib in Indian patients with CLL/SLL, and patients with MCL who have received at least one prior therapy. The data obtained from the study will help to understand the safety and efficacy profile of Acalabrutinib in Indian patients. Patients will be monitored throughout the study period for Adverse Events of Acalabrutinib
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Prospective, Multicentre, Phase-IV study and Clinical trials with a single arm.
| Arm | Type | Receives |
|---|---|---|
| Acalabrutinib Capsule | Experimental | Drug: Acalabrutinib capsuleSingle-arm study |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply:
- 1. Men and Women aged 18yrs or more. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2 3. Able to receive all outpatient treatments, all laboratory monitoring, and all radiologic evaluations.
- Absolute neutrophil count (ANC) ≥750 cells/μL or ≥500 cells/μL in patients with documented bone marrow involvement, and independent of growth factor support 07 days before the assessment
- Platelet count ≥50,000 cells/μL or ≥30,000 cells/μL in patients with documented bone marrow involvement, and without transfusion support 07 days before the assessment
- Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤2.0 x ULN
Key exclusion criteria (15 listed)
- Known prolymphocytic leukaemia, Central Nervous System (CNS) lymphoma or leukaemia; or known history of (or currently suspected) Richter's syndrome
- Treatment with chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days of the first dose of study drug
- Prior radio-conjugated or toxin-conjugated antibody therapy
- Anticoagulation therapy (e.g., warfarin or equivalent vitamin K antagonists) within 07 days of the first dose of study drug.
- Major surgery ≤30 days before the first dose of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acalabrutinib capsuleAlso: Calquence®The recommended dose of Acalabrutinib is 100 mg given per oral (PO) twice daily | Drug | Acalabrutinib Capsule |
Primary outcome
Adverse Events of Special Interest (AESI) Including Arrhythmias (Atrial Fibrillation), Anaemia, Hypertension, Bleeding, Infections
Time frame: Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
The AESIs for acalabrutinib, including arrhythmias (atrial fibrillation), anaemia, hypertension, bleeding, and infections, are presented.
Second Primary Malignancies
Time frame: Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])
The safety of acalabrutinib was investigated by determining the number of second primary malignancies.
2 secondary outcomes
Objective Response to Treatment
Time frame: Visit 5 (Day 85) and Visit 8 (Day 170)
Health Related Quality of Life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQC30] Questionnaire)
Time frame: From Visit 1 (Day 0), during Visit 5 (Day 85), and at Visit 8 (Day 170)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42787222Malhotra P, Bhurani D, Sengar M, Sood N, Nag A, Aribandi A, George B, Menon H, Bhattacharyya J, Kalashetty M, Agrawal N, Sidharthan N, Ahmed R, Shah S, Bhave S, Damodar S. A prospective, multi-center, phase IV clinical study to assess the safety and clinical outcome of acalabrutinib in Indian adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma or relapsed/refractory mantle cell lymphoma. Front Oncol. 2026 Sep 10;16:1822178. doi: 10.3389/fonc.2026.1822178. eCollection 2026.
- CSP\_redactedLink provided by the sponsor.
- SAP\_redactedLink provided by the sponsor.
- CSR\_synopsis-redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acalabrutinib capsule in people with Chronic Lymphocytic Leukemia and Relapsed and Refractory Mantle Cell Lymphoma, run by AstraZeneca at 15 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events of Special Interest (AESI) Including Arrhythmias (Atrial Fibrillation), Anaemia, Hypertension, Bleeding, Infections (time frame: Throughout study completion, approximately 198 days (from the Screening Phase [Day 0], Treatment Phase [Days 1-170], and until the Follow-up Phase [28 days after Day 170])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04930536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.