A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The overall response rate (ORR) will be assessed based on the International Primary CNS Lymphoma Collaborative Group Response assessment criteria. Responder = Partial Response + Complete Response). Complete response (CR) as complete disappearance of contrast enhancement on magnetic resonance imaging (MRI), no evidence of ocular lymphoma, negative cerebrospinal fluid (CSF) cytology, and discontinuation of corticosteroid use for at least 2 weeks prior to the evaluation of response. Unconfirmed CR (Cru) is used to characterize radiographic findings that fulfill the criteria for a CR, but the patient remains on corticosteroids, or MRI that continues to show small but persistent enhancing abnormalities possibly related to biopsy or surgery. Partial response (PR) is defined as a 50% decrease in enhancing tumor or residual disease on eye examinations, or persistent or suspicious CSF cytology.

Source null

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secondary · POSTED

All treatment-attributed adverse events and toxicities will be assessed, classified, and graded in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

Source null

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secondary · POSTED

All treatment-attributed adverse events and toxicities will be assessed, classified, and graded in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting and a grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE

Source null

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secondary · POSTED

Progression-free survival (PFS) is defined from the date of initiating study treatment to the date of disease progression per the International Primary CNS Lymphoma Collaborative Group response assessment criteria or death as a result of any cause. Categories included complete response (no evidence of disease), partial response (reduction in disease burden), stable disease (no significant change), and progressive disease (disease worsening), based on radiographic findings, corticosteroid use, and clinical status.

Source null

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secondary · POSTED

Complete Response (CR) is defined using the International Primary CNS Lymphoma Collaborative Group response assessment criteria for primary CNS lymphoma.

Source null

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secondary · POSTED

Duration of response (DoR) is defined as time from documentation of tumor response to disease progression according to the International Primary CNS Lymphoma Collaborative Group response assessment criteria.

Participants who achieved a complete response were included.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-primary-central-nervous-system-lymphoma
nct id: NCT04548648
trial label: A Pilot Study of Acalabrutinib in Relapsed/Refractory Primary and Secondary CNS Lymphomas
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0000
source section id
NCT04548648-om-0000
source outcome index
0
endpoint
Overall Response Rate
endpoint definition
The overall response rate (ORR) will be assessed based on the International Primary CNS Lymphoma Collaborative Group Response assessment criteria. Responder = Partial Response + Complete Response). Complete response (CR) as complete disappearance of contrast enhancement on magnetic resonance imaging (MRI), no evidence of ocular lymphoma, negative cerebrospinal fluid (CSF) cytology, and discontinuation of corticosteroid use for at least 2 weeks prior to the evaluation of response. Unconfirmed CR (Cru) is used to characterize radiographic findings that fulfill the criteria for a CR, but the patient remains on corticosteroids, or MRI that continues to show small but persistent enhancing abnormalities possibly related to biopsy or surgery. Partial response (PR) is defined as a 50% decrease in enhancing tumor or residual disease on eye examinations, or persistent or suspicious CSF cytology.
time origin
2 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0001
source section id
NCT04548648-om-0001
source outcome index
1
endpoint
Number of Participants With Serious Adverse Events
endpoint definition
All treatment-attributed adverse events and toxicities will be assessed, classified, and graded in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
time origin
up to 3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0002
source section id
NCT04548648-om-0002
source outcome index
2
endpoint
Number of Different Types of Toxicity
endpoint definition
All treatment-attributed adverse events and toxicities will be assessed, classified, and graded in accordance with the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting and a grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE
time origin
up to 3 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0003
source section id
NCT04548648-om-0003
source outcome index
3
endpoint
Progression-free Survival (PFS)
endpoint definition
Progression-free survival (PFS) is defined from the date of initiating study treatment to the date of disease progression per the International Primary CNS Lymphoma Collaborative Group response assessment criteria or death as a result of any cause. Categories included complete response (no evidence of disease), partial response (reduction in disease burden), stable disease (no significant change), and progressive disease (disease worsening), based on radiographic findings, corticosteroid use, and clinical status.
time origin
Up to 400 days (Median 62 days )
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0004
source section id
NCT04548648-om-0004
source outcome index
4
endpoint
Complete Response (CR) Rate
endpoint definition
Complete Response (CR) is defined using the International Primary CNS Lymphoma Collaborative Group response assessment criteria for primary CNS lymphoma.
time origin
2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0005
source section id
NCT04548648-om-0005
source outcome index
5
endpoint
Duration of Response (DoR)
endpoint definition
Duration of response (DoR) is defined as time from documentation of tumor response to disease progression according to the International Primary CNS Lymphoma Collaborative Group response assessment criteria.
time origin
2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who achieved a complete response were included.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0000
arm key
OG000
arm label
Open-label, Single-arm
regimen
Subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) without systemic disease will receive acalabrutinib until disease progression or unacceptable toxicity.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04548648-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0001
arm key
OG000
arm label
Open-label, Single-arm
regimen
Subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) without systemic disease will receive acalabrutinib until disease progression or unacceptable toxicity.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04548648-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0002
arm key
OG000
arm label
Open-label, Single-arm
regimen
Subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) without systemic disease will receive acalabrutinib until disease progression or unacceptable toxicity.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04548648-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0003
arm key
OG000
arm label
Open-label, Single-arm
regimen
Subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) without systemic disease will receive acalabrutinib until disease progression or unacceptable toxicity.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04548648-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0004
arm key
OG000
arm label
Open-label, Single-arm
regimen
Subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) without systemic disease will receive acalabrutinib until disease progression or unacceptable toxicity.
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04548648-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
outcome key
om-0005
arm key
OG000
arm label
Open-label, Single-arm
regimen
Subjects with relapsed primary central nervous system lymphoma (PCNSL) or relapsed secondary CNS lymphoma (SCNSL) without systemic disease will receive acalabrutinib until disease progression or unacceptable toxicity.
analyzed count
1
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04548648-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT04548648
harm key
EG000
source section id
NCT04548648-ae
event group key
EG000
event group label
Open-label, Single-arm
serious affected
5
serious at risk
10
other affected
10
other at risk
10
frequency threshold
0
collection period
Up to 3 years.
event definition
All hospital admissions were considered as serious adverse event per protocol.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice