Trial · NCT00425477
Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
NCT00425477, Phase 2, Completed, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; results first posted 2018-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia. Trials, record NCT00425477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00425477
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bexarotene and GM-CSF in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
- NCT number
- NCT00425477
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Conditions
- Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
- Interventions
- sargramostim, bexarotene, cytogenetic analysis, fluorescence in situ hybridization, flow cytometry, laboratory biomarker analysis, biopsy
- First posted
- 2007-01-23
- Last updated
- 2018-10-05
- Results first posted
- 2018-09-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Response (Complete and Partial) | assessed after 2 cycles, up to 2 years | Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. |
| Secondary | Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements | Baseline and after two cycles | ANC count at baseline and after two cycles were measured and compared. Due to the limited number of clinical responders, the changes in transfusion requirements were not measured. |
| Secondary | Biological Activity as Measured by in Vivo Induction of Terminal Differentiation of Myeloid Progenitors and in Vivo Changes in Detectable Chromosomal Abnormalities | Baseline and 6, 12, 24, and 36 weeks |
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 | Clinical Response (Complete and Partial) | assessed after 2 cycles, up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements | Baseline and after two cycles | neutrophils/mm^3 | MEAN | |
| SECONDARY | Biological Activity as Measured by in Vivo Induction of Terminal Differentiation of Myeloid Progenitors and in Vivo Changes in Detectable Chromosomal Abnormalities | Baseline and 6, 12, 24, and 36 weeks | Due to the limited number of clinical responders, this research assay was not done. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Response (Complete and Partial) | Bexarotene + GM-CSF | PR (partial remission) | 0 | Participants | |
| Clinical Response (Complete and Partial) | Bexarotene + GM-CSF | HI (hematologic improvement) | 4 | Participants | |
| Clinical Response (Complete and Partial) | Bexarotene + GM-CSF | SD (stable disease) | 4 | Participants | |
| Clinical Response (Complete and Partial) | Bexarotene + GM-CSF | PD (progressive disease) | 5 | Participants | |
| Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements | Bexarotene + GM-CSF | ANC at baseline | 524 | Standard Error 95 | neutrophils/mm^3 |
| Clinical Activity as Measured by Change in Peripheral Blood Counts and Changes in Transfusion Requirements | Bexarotene + GM-CSF | ANC after 2 cycles | 931 | Standard Error 244 | neutrophils/mm^3 |
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 | Bexarotene + GM-CSF | 26 | |
| Overall Study | COMPLETED | Bexarotene + GM-CSF | 13 | |
| Overall Study | NOT COMPLETED | Bexarotene + GM-CSF | 13 |
Source ClinicalTrials.gov
Adverse events8
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 | Elevated ALT | Hepatobiliary disorders | Bexarotene + GM-CSF | 3 | 26 | |
| other | Hypertriglyceridemia | Metabolism and nutrition disorders | Bexarotene + GM-CSF | 2 | 26 | |
| other | Muscle weakness | Musculoskeletal and connective tissue disorders | Bexarotene + GM-CSF | 2 | 26 | |
| serious | Neutropenic infection | Infections and infestations | Bexarotene + GM-CSF | 2 | 26 | |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | Bexarotene + GM-CSF | 4 | 26 | |
| serious | Atrial flutter | Cardiac disorders | Bexarotene + GM-CSF | 1 | 26 | |
| serious | acute subdural hemmorrhage | Nervous system disorders | Bexarotene + GM-CSF | 1 | 26 | |
| serious | sepsis | Blood and lymphatic system disorders | Bexarotene + GM-CSF | 2 | 26 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bexarotene + GM-CSF | 3 | 26 |
| Total, other adverse events | Bexarotene + GM-CSF | 7 | 26 |
| Total, serious adverse events | Bexarotene + GM-CSF | 7 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA006973 | Regional Oncology Research Center | NELSON, WILLIAM GEORGE | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00425477
GET https://conductscience.org/api/trials/v1/NCT00425477/registered