Trial · NCT01011920

Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma

NCT01011920, Phase 2, Completed, International Extranodal Lymphoma Study Group (IELSG); results first posted 2026-03-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma. Trials, record NCT01011920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01011920

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial for Patients With Newly Diagnosed Primary Central Nervous System (CNS) Lymphoma
NCT number: NCT01011920
Status: Completed
Phases: Phase 2
Enrollment: 227 participants, actual
Lead sponsor: International Extranodal Lymphoma Study Group (IELSG)
Conditions: Central Nervous System Lymphoma
Interventions: Methotrexate, Ara-C, Rituximab, Thiotepa, radiotherapy, BCNU, APBSCT
First posted: 2009-11-11
Last updated: 2026-03-19
Other registries' IDs: eudract:2009-012432-32
Results first posted: 2026-03-19

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complete Remission Rate After Primary Chemotherapy	3 months after treatment start	Percentage of patients with complete remission after 3 month of treatment. Percentage values are rounded to whole numbers.
Primary	2 Years Failure Free Survival (FFS) After Second Randomization	Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry	Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry. Percentage values are rounded to whole numbers.
Secondary	2 Years Failure Free Survival (FFS)	Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry	Percentage of patients alive and free from disease progression, relapse, need for new treatment, after 2 years from study entry any cause. Percentage values are rounded to whole numbers.
Secondary	2 Year Overall Survival (OS)	From study entry until 2 years after	Percentage of patients alive after 2 years from study entry. Percentage values are rounded to whole numbers.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Complete Remission Rate After Primary Chemotherapy	3 months after treatment start	Percentage of participants	NUMBER
PRIMARY	2 Years Failure Free Survival (FFS) After Second Randomization	Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry	Percentage of participants	NUMBER
SECONDARY	2 Years Failure Free Survival (FFS)	Every 3 weeks during treatment and every 3 months thereafter up to 2 years from study entry	percentage of participants	NUMBER
SECONDARY	2 Year Overall Survival (OS)	From study entry until 2 years after	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group13

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Complete Remission Rate After Primary Chemotherapy	Arm A / MTX + AraC	23	95% Confidence Interval 14 to 31	Percentage of participants
Complete Remission Rate After Primary Chemotherapy	Arm B / MTX + Ara-C + Rituximab	30	95% Confidence Interval 21 to 42	Percentage of participants
Complete Remission Rate After Primary Chemotherapy	Arm C / MTX + Ara-C + Rituximab+Thiotepa	49	95% Confidence Interval 38 to 60	Percentage of participants
2 Years Failure Free Survival (FFS) After Second Randomization	Arm D / WBRT 36 Gy +/- Boost 9 Gy	76	95% Confidence Interval 65 to 87	Percentage of participants
2 Years Failure Free Survival (FFS) After Second Randomization	Arm E / BCNU + Thiotepa + APBSCT	75	95% Confidence Interval 64 to 86	Percentage of participants
2 Years Failure Free Survival (FFS)	Arm A / MTX + AraC	36	99% Confidence Interval 31 to 41	percentage of participants
2 Years Failure Free Survival (FFS)	Arm B / MTX + Ara-C + Rituximab	46	99% Confidence Interval 40 to 52	percentage of participants
2 Years Failure Free Survival (FFS)	Arm C / MTX + Ara-C + Rituximab+Thiotepa	61	99% Confidence Interval 55 to 67	percentage of participants
2 Year Overall Survival (OS)	Arm A / MTX + AraC	42	95% Confidence Interval 36 to 48	percentage of participants
2 Year Overall Survival (OS)	Arm B / MTX + Ara-C + Rituximab	56	95% Confidence Interval 50 to 62	percentage of participants

1 to 10 of 13Source ClinicalTrials.gov

See all 13 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Randomization	STARTED	MTX + AraC	75
First Randomization	STARTED	MTX + Ara-C + Rituximab	69
First Randomization	STARTED	MTX + Ara-C + Rituximab+Thiotepa	75
First Randomization	STARTED	WBRT 36 Gy +/- Boost 9 Gy	0
First Randomization	STARTED	BCNU + Thiotepa + APBSCT	0
First Randomization	COMPLETED	MTX + AraC	46
First Randomization	COMPLETED	MTX + Ara-C + Rituximab	55
First Randomization	COMPLETED	MTX + Ara-C + Rituximab+Thiotepa	66
First Randomization	COMPLETED	WBRT 36 Gy +/- Boost 9 Gy	0
First Randomization	COMPLETED	BCNU + Thiotepa + APBSCT	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events390

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Coagulation disorders	Vascular disorders	Arm A / MTX + AraC	9	75	16
other	Coagulation disorders	Vascular disorders	Arm B / MTX + Ara-C + Rituximab	11	69	18
other	Coagulation disorders	Vascular disorders	Arm C / MTX + Ara-C + Rituximab+Thiotepa	7	75	11
other	Coagulation disorders	Vascular disorders	Arm D / WBRT 36 Gy +/- Boost 9 Gy	5	55	5
other	Coagulation disorders	Vascular disorders	Arm E / BCNU + Thiotepa + APBSCT	7	58	7
other	Neurological toxicity	Nervous system disorders	Arm A / MTX + AraC	13	75	34
other	Neurological toxicity	Nervous system disorders	Arm B / MTX + Ara-C + Rituximab	18	69	38
other	Neurological toxicity	Nervous system disorders	Arm C / MTX + Ara-C + Rituximab+Thiotepa	13	75	27
other	Neurological toxicity	Nervous system disorders	Arm D / WBRT 36 Gy +/- Boost 9 Gy	10	55	10
other	Neurological toxicity	Nervous system disorders	Arm E / BCNU + Thiotepa + APBSCT	4	58	4

1 to 10 of 390Source ClinicalTrials.gov

See all 390 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A / MTX + AraC	56	75
Total, all-cause mortality	Arm B / MTX + Ara-C + Rituximab	41	69
Total, all-cause mortality	Arm C / MTX + Ara-C + Rituximab+Thiotepa	33	75
Total, all-cause mortality	Arm D / WBRT 36 Gy +/- Boost 9 Gy	30	55
Total, all-cause mortality	Arm E / BCNU + Thiotepa + APBSCT	23	58
Total, other adverse events	Arm A / MTX + AraC	75	75
Total, other adverse events	Arm B / MTX + Ara-C + Rituximab	68	69
Total, other adverse events	Arm C / MTX + Ara-C + Rituximab+Thiotepa	74	75
Total, other adverse events	Arm D / WBRT 36 Gy +/- Boost 9 Gy	38	55
Total, other adverse events	Arm E / BCNU + Thiotepa + APBSCT	49	58

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27132696	DERIVED	PubMed
29054815	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01011920

GET https://conductscience.org/api/trials/v1/NCT01011920/flow?page=2

API reference For AI assistants