Trial · NCT00078949

Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

NCT00078949, Phase 3, Completed, NCIC Clinical Trials Group; results first posted 2014-10-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma. Trials, record NCT00078949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00078949

On this page

Trial

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

Title: Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
NCT number: NCT00078949
Status: Completed
Phases: Phase 3
Enrollment: 849 participants, actual
Lead sponsor: NCIC Clinical Trials Group
Conditions: Lymphoma
Interventions: rituximab, cisplatin, cytarabine, dexamethasone, gemcitabine hydrochloride
First posted: 2004-03-09
Last updated: 2023-08-23
Results first posted: 2014-10-21

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Response Rate of Patients After 2 Courses of Chemotherapy	After 2 cycle of treatment	The overall response rate by arm is calculated as total number of responders (CR + CRu + PR) / (all patients in the ITT analysis population).
Primary	Transplantation Rate of Patients After 2 Courses of Chemotherapy	During period 1 (salvage chemotherapy)	Transplantation rate is defined as the number of patients who respond sufficiently to protocol salvage chemotherapy to be planned for transplantation minus those who do not meet the endpoint of successful transplantation, divided by the number of all randomized patients
Primary	Event-free Survival of Patients on Maintenance Randomization (Period 2)	during the period 2 (up to10 years)	Number of patients who develop EFS event during maintenance randomization (period 2)
Secondary	Toxic Effect	48 months	Number of patients affected by adverse events graded according to CTC Version 2.0. See adverse event (others) for details.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Rate of Patients After 2 Courses of Chemotherapy	After 2 cycle of treatment	ITT population	percentage of response	NUMBER
PRIMARY	Transplantation Rate of Patients After 2 Courses of Chemotherapy	During period 1 (salvage chemotherapy)		percentage of transplantation	NUMBER
PRIMARY	Event-free Survival of Patients on Maintenance Randomization (Period 2)	during the period 2 (up to10 years)	ITT population	participants	NUMBER
SECONDARY	Toxic Effect	48 months	All patients who received the protocol treatment.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Units
Response Rate of Patients After 2 Courses of Chemotherapy	Salvage GDP	45.2	percentage of response
Response Rate of Patients After 2 Courses of Chemotherapy	Salvage DHAP	44.0	percentage of response
Transplantation Rate of Patients After 2 Courses of Chemotherapy	Salvage GDP	51.0	percentage of transplantation
Transplantation Rate of Patients After 2 Courses of Chemotherapy	Salvage DHAP	48.9	percentage of transplantation
Event-free Survival of Patients on Maintenance Randomization (Period 2)	Maintenance	53	participants
Event-free Survival of Patients on Maintenance Randomization (Period 2)	Observation	65	participants
Toxic Effect	Salvage GDP	36	Participants
Toxic Effect	Salvage DHAP	26	Participants
Toxic Effect	Maintenance	16	Participants
Toxic Effect	Observation	8	Participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Salvage GDP	310
Overall Study	STARTED	Salvage DHAP	309
Overall Study	STARTED	Maintenance	115
Overall Study	STARTED	Observation	115
Overall Study	COMPLETED	Salvage GDP	306
Overall Study	COMPLETED	Salvage DHAP	304
Overall Study	COMPLETED	Maintenance	112
Overall Study	COMPLETED	Observation	112
Overall Study	NOT COMPLETED	Salvage GDP	4
Overall Study	NOT COMPLETED	Salvage DHAP	5

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events420

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
other	Febrile neutropenia	Blood and lymphatic system disorders	Salvage GDP	28	306
other	Febrile neutropenia	Blood and lymphatic system disorders	Salvage DHAP	71	304
other	Febrile neutropenia	Blood and lymphatic system disorders	Maintenance	10	112
other	Febrile neutropenia	Blood and lymphatic system disorders	Observation	3	112
other	Edema	Cardiac disorders	Salvage GDP	39	306
other	Edema	Cardiac disorders	Salvage DHAP	64	304
other	Edema	Cardiac disorders	Maintenance	8	112
other	Edema	Cardiac disorders	Observation	9	112
other	Inner ear/hearing	Ear and labyrinth disorders	Salvage GDP	50	306
other	Inner ear/hearing	Ear and labyrinth disorders	Salvage DHAP	76	304

1 to 10 of 420Source ClinicalTrials.gov

See all 420 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Salvage GDP	177	310
Total, all-cause mortality	Salvage DHAP	181	309
Total, all-cause mortality	Maintenance	39	115
Total, all-cause mortality	Observation	42	115
Total, other adverse events	Salvage GDP	287	306
Total, other adverse events	Salvage DHAP	293	304
Total, other adverse events	Maintenance	98	112
Total, other adverse events	Observation	90	112
Total, serious adverse events	Salvage GDP	36	306
Total, serious adverse events	Salvage DHAP	26	304

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25267740	RESULT	PubMed
26109202	DERIVED	PubMed
27993811	DERIVED	PubMed
29097500	DERIVED	PubMed
32396614	DERIVED	PubMed
37226534	BACKGROUND	PubMed
40503814	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 comparisons1

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

Comparison
Maintenance vs Observation: Event-free Survival of Patients on Maintenance Randomization (Period 2)

Source 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/NCT00078949

GET https://conductscience.org/api/trials/v1/NCT00078949/events?page=2

API reference For AI assistants