Trial · NCT00940342
Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
NCT00940342, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2018-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia. Trials, record NCT00940342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00940342
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rituximab Plus Sargramostim (GM-CSF) In Patients With Chronic Lymphocytic Leukemia
- NCT number
- NCT00940342
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 130 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- GM-CSF (Sargramostim), Rituximab
- First posted
- 2009-07-16
- Last updated
- 2018-09-19
- Results first posted
- 2018-09-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | Blood tests once a week during 8 weeks of treatment. | Overall Response Rate - Complete Response (CR) + Partial Response (PR). CR is the absence of Lymphocyte infiltrates on biopsy, \<30% Lymphocytes on Bone Marrow Aspirate, Lymphocytes \< 4,000ul , Hemoglobin \>11.0 g/dl , Platelets \>1000,000/ul, Polymorphonuclear neutrophils (PMN) \>1,500/ul, Liver/Spleen not palpable, Nodes none. PR is \<30% Lymphocytes with residual disease on biopsy for nodular PR, Lymphocytes \>50% decrease, Hemoglobin (un-transfused) \> 11.0 g/dl or \>50% improvement from baseline, Platelets \> 100,000/ul or 50% improvement from baseline, PMN \>1,500 ul or 50% improvement from baseline, Liver/Spleen \>/= 50% decrease, Nodes \>/= 50%. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | Blood tests once a week during 8 weeks of treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Treated and Relapsed - Group 1 | 23 | Participants | ||
| Overall Response Rate | Untreated and High-Risk for Progression - Group 2 | 31 | Participants | ||
| Overall Response Rate | 70 Years of Age and Refused Chemo - Group 3 | 23 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treated and Relapsed - Group 1 | 50 | |
| Overall Study | STARTED | Untreated and High-Risk for Progression - Group 2 | 40 | |
| Overall Study | STARTED | 70 Years of Age and Refused Chemo - Group 3 | 40 | |
| Overall Study | COMPLETED | Treated and Relapsed - Group 1 | 50 | |
| Overall Study | COMPLETED | Untreated and High-Risk for Progression - Group 2 | 38 | |
| Overall Study | COMPLETED | 70 Years of Age and Refused Chemo - Group 3 | 39 | |
| Overall Study | NOT COMPLETED | Treated and Relapsed - Group 1 | 0 | |
| Overall Study | NOT COMPLETED | Untreated and High-Risk for Progression - Group 2 | 2 | |
| Overall Study | NOT COMPLETED | 70 Years of Age and Refused Chemo - Group 3 | 1 |
Source ClinicalTrials.gov
Adverse events54
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 | Injection Site Reaction | Skin and subcutaneous tissue disorders | Treated and Relapsed - Group 1 | 6 | 50 | 6 |
| other | Injection Site Reaction | Skin and subcutaneous tissue disorders | Untreated and High-Risk for Progression - Group 2 | 10 | 40 | 10 |
| other | Injection Site Reaction | Skin and subcutaneous tissue disorders | 70 Years of Age and Refused Chemo - Group 3 | 10 | 40 | 10 |
| other | Pain | General disorders | Treated and Relapsed - Group 1 | 4 | 50 | 4 |
| other | Pain | General disorders | Untreated and High-Risk for Progression - Group 2 | 4 | 40 | 4 |
| other | Pain | General disorders | 70 Years of Age and Refused Chemo - Group 3 | 1 | 40 | 1 |
| other | Fever | General disorders | Treated and Relapsed - Group 1 | 3 | 50 | 3 |
| other | Fever | General disorders | Untreated and High-Risk for Progression - Group 2 | 1 | 40 | 1 |
| other | Fever | General disorders | 70 Years of Age and Refused Chemo - Group 3 | 1 | 40 | 1 |
| other | Chills | General disorders | Treated and Relapsed - Group 1 | 3 | 50 | 3 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treated and Relapsed - Group 1 | 3 | 50 |
| Total, all-cause mortality | Untreated and High-Risk for Progression - Group 2 | 0 | 40 |
| Total, all-cause mortality | 70 Years of Age and Refused Chemo - Group 3 | 1 | 40 |
| Total, other adverse events | Treated and Relapsed - Group 1 | 21 | 50 |
| Total, other adverse events | Untreated and High-Risk for Progression - Group 2 | 16 | 40 |
| Total, other adverse events | 70 Years of Age and Refused Chemo - Group 3 | 15 | 40 |
| Total, serious adverse events | Treated and Relapsed - Group 1 | 5 | 50 |
| Total, serious adverse events | Untreated and High-Risk for Progression - Group 2 | 3 | 40 |
| Total, serious adverse events | 70 Years of Age and Refused Chemo - Group 3 | 4 | 40 |
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 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.
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/NCT00940342
GET https://conductscience.org/api/trials/v1/NCT00940342/events?page=2