Study of High-Dose Rituximab With Temozolomide as Treatment for Primary Central Nervous System (CNS) Lymphoma

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

Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that is neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for progressive disease.

The study closed early due to slow accrual. This outcome measure was not reached.

→

secondary · POSTED

Six and twelve-month CNS progression-free survival rate.

The study closed early due to slow accrual; outcome measure not reached.

→

secondary · POSTED

Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.

Source null

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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: NCT02113007
trial label: Study of High-Dose Rituximab With Temozolomide as Treatment for Primary Central Nervous System (CNS) Lymphoma
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: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT02113007
outcome key
om-0000
source section id
NCT02113007-om-0000
source outcome index
0
endpoint
Overall Response Rate
endpoint definition
Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that is neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for progressive disease.
time origin
approximately 32 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The study closed early due to slow accrual. This outcome measure was not reached.
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
NCT02113007
outcome key
om-0001
source section id
NCT02113007-om-0001
source outcome index
1
endpoint
Progression Free Survival (PFS)
endpoint definition
Six and twelve-month CNS progression-free survival rate.
time origin
6 and 12 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The study closed early due to slow accrual; outcome measure not reached.
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
NCT02113007
outcome key
om-0002
source section id
NCT02113007-om-0002
source outcome index
2
endpoint
Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety.
endpoint definition
Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.
time origin
up to 4 weeks
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

arms

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT02113007
outcome key
om-0000
arm key
OG000
arm label
Rituximab Plus Temozolomide
regimen
Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5 Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113007-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT02113007
outcome key
om-0001
arm key
OG000
arm label
Rituximab Plus Temozolomide
regimen
Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5 Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113007-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT02113007
outcome key
om-0002
arm key
OG000
arm label
Rituximab Plus Temozolomide
regimen
Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5 Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02113007-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT02113007
harm key
EG000
source section id
NCT02113007-ae
event group key
EG000
event group label
Rituximab Plus Temozolomide
serious affected
1
serious at risk
2
other affected
2
other at risk
2
frequency threshold
0
collection period
Adverse events and serious adverse events were collected for up to 4 weeks during the safety lead-in part of the study. The study closed early due to slow accrual.
event definition
Source null
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