Trial · NCT00308087

Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma

NCT00308087, Phase 2, Terminated, Genzyme, a Sanofi Company; results first posted 2010-08-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma. Trials, record NCT00308087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00308087

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Trial

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

Title: Comparison Study of Rituximab Plus Sargramostim to Rituximab Alone for Relapsed Follicular B-cell Lymphoma, a Form of Non-Hodgkin's Lymphoma
NCT number: NCT00308087
Status: Terminated
Phases: Phase 2
Enrollment: 75 participants, actual
Lead sponsor: Genzyme, a Sanofi Company
Conditions: Lymphoma, Follicular
Interventions: Sargramostim (Leukine), Rituximab
First posted: 2006-03-29
Last updated: 2013-12-27
Results first posted: 2010-08-30
Limitations and caveats: One hundred ninety-six patients were planned and 75 enrolled prior to termination. The study was terminated early due to low enrollment, and the extent of changes needed to the protocol to keep pace with therapeutic changes for indolent lymphoma.

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12	Week 8 (confirmed at Week 12)	Count of number of participants who responded with a Complete Response (complete disappearance of all detectable clinical and radiological evidence of disease) at week 8 and again clinically and radiologically confirmed at week 12.
Secondary	Summary of Treatment-Emergent Adverse Events (TEAE)	up to 12 weeks	Count of the number of participants who experienced treatment emergent adverse events (TEAEs). TEAEs occurred during the time study intervention was being taken occurring on or after Day 1 and no longer than 30 days after the last dose of study medication.
Secondary	Participant Summary of Best Response Across All Visits	up to 24 months	Count of participants' best response within categories defined by the International Working Group (IWG): \> Complete Response (complete disappearance of detectable clinical and radiological evidence of disease), \> Complete Response Unconfirmed (unconfirmed complete disappearance), \> Partial Response (\>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses), \> Stable Disease (neither response nor disease progression), \> Progression (new lesion or increase by 50% of previously involved sites from nadir).
Secondary	Kaplan-Meier Estimates of Progression-Free Survival	24 months	Time to event was measured from the date of randomization to the date of first progressive disease (PD) or death.
Secondary	Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment	24 months	Count of days in which a participant experiences a Partial Response (\>=50% decrease sum of the product of the greatest diameters in the six largest dominant nodes or nodal masses) or better. Time to event was measured from the date of response to the date of progressive disease (PD) or death.
Secondary	Summary of Cost Effectiveness	24 months	A cost-effectiveness analysis from the payer perspective was to be performed. Only direct medical costs for each patient during the study period were to be included for analysis. Costs were to be calculated by multiplying each health care resource unit by the amount reimbursed by a payer. Health care resource utilization units are a way to normalize the quantity of health care provided to each participant so that costs can be compared.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12	Week 8 (confirmed at Week 12)	Intent to treat population	participants	NUMBER
SECONDARY	Summary of Treatment-Emergent Adverse Events (TEAE)	up to 12 weeks	Safety population	participants	NUMBER
SECONDARY	Participant Summary of Best Response Across All Visits	up to 24 months	Intent to treat population	participants	NUMBER
SECONDARY	Kaplan-Meier Estimates of Progression-Free Survival	24 months	Intent to treat population	Days	MEDIAN
SECONDARY	Kaplan-Meier Estimates for Duration of Partial Response or Better to Treatment	24 months	Intent to treat population.	Days	MEDIAN
SECONDARY	Summary of Cost Effectiveness	24 months	No participants were analyzed because the study was terminated early due to low enrollment.

Source ClinicalTrials.gov

Results by group28

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

Outcome	Group	Category	Value	Units
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12	Rituximab		1	participants
Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12	Rituximab + Sargramostim		3	participants
Summary of Treatment-Emergent Adverse Events (TEAE)	Rituximab	Patients with TEAEs	34	participants
Summary of Treatment-Emergent Adverse Events (TEAE)	Rituximab + Sargramostim	Patients with TEAEs	38	participants
Summary of Treatment-Emergent Adverse Events (TEAE)	Rituximab	Patients with Treatment-Related TEAEs	21	participants
Summary of Treatment-Emergent Adverse Events (TEAE)	Rituximab + Sargramostim	Patients with Treatment-Related TEAEs	37	participants
Summary of Treatment-Emergent Adverse Events (TEAE)	Rituximab	Number of Deaths	0	participants
Summary of Treatment-Emergent Adverse Events (TEAE)	Rituximab + Sargramostim	Number of Deaths	0	participants
Summary of Treatment-Emergent Adverse Events (TEAE)	Rituximab	Patients with Serious TEAEs	4	participants
Summary of Treatment-Emergent Adverse Events (TEAE)	Rituximab + Sargramostim	Patients with Serious TEAEs	4	participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Rituximab	37
Overall Study	STARTED	Rituximab + Sargramostim	38
Overall Study	COMPLETED	Rituximab	1
Overall Study	COMPLETED	Rituximab + Sargramostim	1
Overall Study	NOT COMPLETED	Rituximab	36
Overall Study	NOT COMPLETED	Rituximab + Sargramostim	37

Source ClinicalTrials.gov

Adverse events356

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	Anaemia	Blood and lymphatic system disorders	Rituximab	0	37
other	Anaemia	Blood and lymphatic system disorders	Rituximab + Sargramostim	1	38
other	Leukocytosis	Blood and lymphatic system disorders	Rituximab	0	37
other	Leukocytosis	Blood and lymphatic system disorders	Rituximab + Sargramostim	3	38
other	Leukopenia	Blood and lymphatic system disorders	Rituximab	1	37
other	Leukopenia	Blood and lymphatic system disorders	Rituximab + Sargramostim	2	38
other	Lymphopenia	Blood and lymphatic system disorders	Rituximab	2	37
other	Lymphopenia	Blood and lymphatic system disorders	Rituximab + Sargramostim	0	38
other	Neutropenia	Blood and lymphatic system disorders	Rituximab	0	37
other	Neutropenia	Blood and lymphatic system disorders	Rituximab + Sargramostim	3	38

1 to 10 of 356Source ClinicalTrials.gov

See all 356 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rituximab
Total, all-cause mortality	Rituximab + Sargramostim
Total, other adverse events	Rituximab	33	37
Total, other adverse events	Rituximab + Sargramostim	38	38
Total, serious adverse events	Rituximab	5	37
Total, serious adverse events	Rituximab + Sargramostim	7	38

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
Rituximab vs Rituximab + Sargramostim: Number of Participants With a Complete Response or Unconfirmed Complete Response at Week 8 With Confirmation at Week 12	Trial comparisons
Rituximab vs Rituximab + Sargramostim: 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/NCT00308087

GET https://conductscience.org/api/trials/v1/NCT00308087/results?page=2

API reference For AI assistants