Acalabrutinib and Rituximab for Diffuse Large B-Cell Lymphoma
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
Recruiting
Phase 2Interventional Study
Diffuse Large B-Cell Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 – 99
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for
This trial is looking for elderly and frail patients who have been newly diagnosed with diffuse large B-cell lymphoma and have not received any prior treatment. Participants will take a combination of two medications, acalabrutinib and rituximab, to see how safe and effective this approach is.
Are You a Good Fit for This Trial?
You may be able to join if
I am 65 years old or older.
I have been diagnosed with diffuse large B-cell lymphoma.
I have not been treated for diffuse large B-cell lymphoma before.
My cancer is stage II, III, or IV.
I have at least one measurable lymphoma lesion.
I have good organ and marrow function.
You may not be able to join if
I have uncontrolled health issues like severe infections or active bleeding.
I have had other cancers that could affect the study.
I have active hepatitis B or C.
I am infected with HIV.
My lymphoma has affected my central nervous system.
I have a high Cumulative Illness Rating Scale score.
I have had a stroke or bleeding in my brain in the last 6 months.
I have had major surgery recently or need it soon.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.
Trial Locations
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Eligibility Criteria
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 .
…
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.
* Serological positivity or known infection with 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 \> 17.
* History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
* Known 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).
* 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.
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