Trial · NCT00381004
FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
NCT00381004, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2015-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia. Trials, record NCT00381004. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00381004
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FCR Plus Sargramostim (GM-CSF) as Frontline Therapy for Symptomatic Chronic Lymphocytic Leukemia
- NCT number
- NCT00381004
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 60 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Chronic Lymphocytic Leukemia
- Interventions
- Cyclophosphamide, Fludarabine, Sargramostim, Rituximab
- First posted
- 2006-09-27
- Last updated
- 2016-01-14
- Results first posted
- 2015-08-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. | Baseline to 6 Months | Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)\</=4x10\^9/L, Hb\>11 g/dL, absolute neutrophil count (ANC)\>/=1.5x109/L, \& platelet count\>100x109/L. Bone marrow:\<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb\>11 g/dL or 50% improvement (imp.) in deviation, or ANC\>/=1.5x109/L or 50% imp., or platelet\>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC\</=4x109/L + Hb\>11 g/dL, ANC\>/=1.5x109/L \& platelet count\>100x109/L; \<30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC\>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression \&/or appearance new malignant disease; Reappearance bone marrow disease. |
| Primary | Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. | Baseline to 6 Months | Complete Remission:Normal exam/No symptoms; Absolute lymphocyte count (ALC)\</=4x10\^9/L, Hb\>11 g/dL, absolute neutrophil count (ANC)\>/=1.5x109/L, \& platelet count\>100x109/L. Bone marrow:\<30% lymphocytes aspirate no biopsy evidence disease; Disappearance palpable lymph nodes/spleen/liver, no new lesions. Partial Remission:ALC reduced 50%,either Hb\>11 g/dL or 50% improvement (imp.) in deviation, or ANC\>/=1.5x109/L or 50% imp., or platelet\>100x109/L or 50% imp. in deviation from normal. Reduced 50% palpable lymph nodes/spleen/liver no new lesions. Nodular Partial Response:ALC\</=4x109/L + Hb\>11 g/dL, ANC\>/=1.5x109/L \& platelet count\>100x109/L; \<30% lymphocytes - bone marrow biopsy aspirate + lymphoid nodules;No palpable lymph nodes/spleen/liver tumors without new lesions. Progressive Disease:50% increase (incr.) ALC\>10x109/L twice; tumor lesion incr. 50% over entry or responder size at time max regression \&/or appearance new malignant disease; Reappearance bone marrow disease. |
| Secondary | Number of Participants Progression-free | 6 months or until disease progression if earlier | Participants progression free as measured at six months following start of treatment. Criteria for Progressive Disease (PD): Peripheral blood: 50% increase in ALC with a level \> 10 x 109/L on at least 2 occasions 2 weeks apart. Tumor: An increase of a lesion by 50% over the size present at entry on study or for patients who respond, the size at the time of maximum regression and/or the appearance of new areas of malignant disease. Reappearance of bone marrow disease. A deterioration in performance status or increasing symptoms do not constitute disease progression. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. | Baseline to 6 Months | Percentage of Participants | NUMBER | |
| SECONDARY | Number of Participants Progression-free | 6 months or until disease progression if earlier | participants | NUMBER | |
| PRIMARY | Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. | Baseline to 6 Months | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participant Overall Response Rate (ORR) at 6 Months Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. | FCR + Sargramostim | 100 | Percentage of Participants | ||
| Number of Participants Progression-free | FCR + Sargramostim | 60 | participants | ||
| Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. | FCR + Sargramostim | Complete Response (CR) | 45 | Participants | |
| Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. | FCR + Sargramostim | Nodular Partial Response (nPR) | 6 | Participants | |
| Number of Participants With Overall Response Includes Complete Remissions, Partial Remission, or Nodule Partial Remissions. | FCR + Sargramostim | Partial Response (PD) | 9 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FCR + Sargramostim | 60 | |
| Overall Study | COMPLETED | FCR + Sargramostim | 60 | |
| Overall Study | NOT COMPLETED | FCR + Sargramostim | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Pain/erythema at injection site | Skin and subcutaneous tissue disorders | FCR + Sargramostim | 4 | 60 | 4 |
| serious | DEHYDRATION | Gastrointestinal disorders | FCR + Sargramostim | 1 | 60 | 1 |
| serious | DIARRHEA | Gastrointestinal disorders | FCR + Sargramostim | 1 | 60 | 1 |
| serious | DEATH | General disorders | FCR + Sargramostim | 1 | 60 | 1 |
| serious | FEVER OF UNKNOWN ORIGIN | General disorders | FCR + Sargramostim | 1 | 60 | 1 |
| serious | FEBRILE NEUTROPENIA | Infections and infestations | FCR + Sargramostim | 2 | 60 | 2 |
| serious | INFECTION | Infections and infestations | FCR + Sargramostim | 2 | 60 | 2 |
| serious | SECONDARY MALIGNANCY DUCTAL CARCINOMA IN SITU RIGHT BREAST | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | FCR + Sargramostim | 1 | 60 | 1 |
| serious | SECONDARY MALIGNANCY MDS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | FCR + Sargramostim | 3 | 60 | 3 |
| serious | SECONDARY MALIGNANCY SQUAMOUS CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | FCR + Sargramostim | 1 | 60 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FCR + Sargramostim | ||
| Total, other adverse events | FCR + Sargramostim | 4 | 60 |
| Total, serious adverse events | FCR + Sargramostim | 12 | 60 |
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/NCT00381004
GET https://conductscience.org/api/trials/v1/NCT00381004/registered