Trial · NCT01511562

Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma

NCT01511562, Phase 2, Completed, Alliance for Clinical Trials in Oncology; results first posted 2026-01-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma. Trials, record NCT01511562. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01511562

On this page

Trial

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

Title: Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma
NCT number: NCT01511562
Status: Completed
Phases: Phase 2
Enrollment: 113 participants, actual
Lead sponsor: Alliance for Clinical Trials in Oncology
Conditions: Lymphoma
Interventions: carmustine, cytarabine, etoposide, thiotepa, stem cell transplant, G-CSF
First posted: 2012-01-18
Last updated: 2026-09-24
Results first posted: 2026-01-14

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Progression Free Survival	2 years	The primary endpoint is to compare the two-year progression-free survival (PFS) of patients treated with the myeloablative consolidation treatment strategy of HDT/ASCT versus those treated with non-myeloablative consolidation chemotherapy with cytarabine and etoposide. PFS time = time from Registration to earliest date of Progression or Death due to any cause, censoring non-progressed and alive patients at the date of last disease status evaluation. Response will be defined using the modified IPCG criteria. Progressive disease is defined as \> 25% increase in contrast-enhancing CNS (brain and spine if latter abnormal at baseline) disease, appearance of any new, measurable (\>/= 10mm) contrast-enhancing disease or recurrent or new ocular or CSF disease.
Secondary	Event Free Survival	2 years	To compare the two-year event-free survival (EFS) of patients treated with consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. EFS event = same definition as PFS with non-protocol treatment also considered an event
Secondary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	7 years	Number of patients reporting at least one adverse event at least possibly related to treatment.
Secondary	Overall Survival	2 years	To compare the overall survival (OS) of patients treated with the consolidation HDT/ASCT versus those treated with consolidation chemotherapy consisting of etoposide and cytarabine. OS event = Registration/Randomization to Death due to any cause

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Progression Free Survival	2 years	percentage of participants w/out event	NUMBER
SECONDARY	Event Free Survival	2 years	percentage of participants w/out event	NUMBER
SECONDARY	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	7 years	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Overall Survival	2 years	percentage of participants alive	NUMBER

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Progression Free Survival	Arm I	72.9	95% Confidence Interval 58.5 to 83.0	percentage of participants w/out event
Progression Free Survival	Arm II	50.6	95% Confidence Interval 36.1 to 63.3	percentage of participants w/out event
Event Free Survival	Arm I	65.7	95% Confidence Interval 51.2 to 76.9	percentage of participants w/out event
Event Free Survival	Arm II	48.5	95% Confidence Interval 34.2 to 61.4	percentage of participants w/out event
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Arm I	54		Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Arm II	53		Participants
Overall Survival	Arm I	86.6	95% Confidence Interval 73.9 to 93.4	percentage of participants alive
Overall Survival	Arm II	78.3	95% Confidence Interval 64.3 to 87.4	percentage of participants alive

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Induction	STARTED	Arm I	54
Induction	STARTED	Arm II	54
Induction	COMPLETED	Arm I	45
Induction	COMPLETED	Arm II	40
Induction	NOT COMPLETED	Arm I	9
Induction	NOT COMPLETED	Arm II	14
Consolidation	STARTED	Arm I	38
Consolidation	STARTED	Arm II	34
Consolidation	COMPLETED	Arm I	36
Consolidation	COMPLETED	Arm II	34

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events600

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	Anemia	Blood and lymphatic system disorders	Arm I	53	54	381
other	Anemia	Blood and lymphatic system disorders	Arm II	48	54	233
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	Arm I	9	54	13
other	Blood and lymph sys disorders - Oth Spec	Blood and lymphatic system disorders	Arm II	1	54	10
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm I	22	54	26
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm II	15	54	17
other	Leukocytosis	Blood and lymphatic system disorders	Arm I	4	54	5
other	Leukocytosis	Blood and lymphatic system disorders	Arm II	1	54	1
other	Acute coronary syndrome	Cardiac disorders	Arm I	1	54	1
other	Acute coronary syndrome	Cardiac disorders	Arm II	0	54	0

1 to 10 of 600Source ClinicalTrials.gov

See all 600 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I	11	54
Total, all-cause mortality	Arm II	15	54
Total, other adverse events	Arm I	54	54
Total, other adverse events	Arm II	53	54
Total, serious adverse events	Arm I	21	54
Total, serious adverse events	Arm II	33	54

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38598710	DERIVED

Source 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 comparisons3

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

Comparison	Source
Arm I vs Arm II: deaths from any cause	Trial comparisons
Arm I vs Arm II: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Trial comparisons
Arm I vs Arm II: serious adverse events	Trial comparisons

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/NCT01511562

GET https://conductscience.org/api/trials/v1/NCT01511562/events?page=2

API reference For AI assistants