Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL (ACRUE)
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ClinicalTrials.gov Identifier: NCT05952024 |
Recruitment Status :
Not yet recruiting
First Posted : July 19, 2023
Last Update Posted : December 5, 2023
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Condition or disease | Intervention/treatment | Phase |
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Diffuse Large B-Cell Lymphoma | Drug: Acalabrutinib Biological: Rituximab | Phase 2 |
Treatment-naïve elderly and/or frail patients with DLBCL will be treated with acalabrutinib in combination with rituximab in a single arm.
Study details include the following:
- The study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up.
- The treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE) |
Estimated Study Start Date : | March 29, 2024 |
Estimated Primary Completion Date : | September 29, 2027 |
Estimated Study Completion Date : | September 29, 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Acalabrutinib and Rituximab
Patients will receive Dose A of acalabrutinib orally in X dosing schedule beginning on Cycle 1 Day 1 for a maximum of 28 cycles or until 2014 Lugano Classification for Non-Hodgkin's Lymphoma (NHL)-defined disease progression or another discontinuation criterion is met. Patients will also receive an intravenous (IV) infusion of Dose B rituximab on Cycle 1 Day 15 and Dose C of rituximab as an subcutaneous (SC) injection on Day 1 of Cycle 2 through Cycle 8.
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Drug: Acalabrutinib
Patients will receive acalabrutinib orally with dosing schedule of X.
Other Name: CALQUENCE® Biological: Rituximab Patients will receive rituximab via IV infusion on Cycle 1 Day 15 and via SC injection on Day 1 of Cycle 2 through Cycle 8. |
- Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs) [ Time Frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) through End of treatment EoT [30 days of discontinuation] (Up to 3.5 Years) ]
- Objective response rate (ORR) [ Time Frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years) ]
- Progression free survival (PFS) [ Time Frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years) ]
- Event-Free Survival (EFS) [ Time Frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years) ]
- Overall survival (OS) [ Time Frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until Post-treatment follow-up (Up to 3.5 Years) ]
- Duration of response (DoR) [ Time Frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years) ]
- Change from baseline in Timed Up and Go test (TUG) [ Time Frame: Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until Post-treatment follow-up (Up to 3.5 Years) ]
- Number of patients with adverse events [ Time Frame: Screening (up to 28 days before day 1) Until Post-treatment follow-up (Up to 3.5 Years) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years to 99 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥ 80 years of age at the time of screening, or
- ≥ 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy
- Histologically documented DLBCL
- No prior treatment for DLBCL
- Stage II, III, or IV disease by the Ann Arbor Classification .
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma.
- At least 1 lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements.
- Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.
Exclusion Criteria:
- Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol.
- History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.
- Serologic status reflecting active hepatitis B or C infection.
- Known to have tested positive for HIV.
- Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
- Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of > 6.
- History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
- Known history of infection with HIV or any active significant infection.
- History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.
- History of bleeding diathesis (eg, haemophilia, von Willebrand disease).
- Any concurrent anticancer treatment.
- Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.
- Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
- Received a live virus vaccination within 28 days of the first dose of study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952024
Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT05952024 |
Other Study ID Numbers: |
D8227C00002 |
First Posted: | July 19, 2023 Key Record Dates |
Last Update Posted: | December 5, 2023 |
Last Verified: | November 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
Access Criteria: | When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Chemoimmunotherapy treatments Treatment-naïve elderly patients |
Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Rituximab |
Acalabrutinib Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Tyrosine Kinase Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |