Trial · NCT00462605
MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
NCT00462605, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-04-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia. Trials, record NCT00462605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00462605
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
- NCT number
- NCT00462605
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Refractory Anemia, Refractory Anemia With Excess Blasts, Refractory Anemia With Ringed Sideroblasts, Refractory Cytopenia With Multilineage Dysplasia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia
- Interventions
- entinostat, sargramostim
- First posted
- 2007-04-19
- Last updated
- 2017-07-18
- Results first posted
- 2017-04-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response (Complete and Partial Response) in Patients With Myeloid Disorders | Up to 2 years | Response to treatment was assessed after two cycles, according to International Working Group (IWG) criteria. Cytogenetic responses were monitored in patients with abnormalities at baseline. |
| Secondary | Clinical Activity Assessed by Change in Peripheral Blood Counts | Baseline and after 2 cycles | |
| Secondary | Clinical Activity Assessed by Change in Transfusion Requirements | Baseline and after 2 cycles | |
| Secondary | Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH) | Baseline and 6, 12, 24, and 36 weeks | |
| Secondary | Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry | Baseline and 6, 12, 24, and 36 weeks |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response (Complete and Partial Response) in Patients With Myeloid Disorders | Up to 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Clinical Activity Assessed by Change in Peripheral Blood Counts | Baseline and after 2 cycles | cell/mm^3 | MEAN | |
| SECONDARY | Clinical Activity Assessed by Change in Transfusion Requirements | Baseline and after 2 cycles | Due to the limited number of clinical responders, this outcome was not measured. | ||
| SECONDARY | Changes in Detectable Chromosomal Abnormalities Measured by Fluorescent in Situ Hybridization (FISH) | Baseline and 6, 12, 24, and 36 weeks | Due to the limited number of clinical responders, the research assay was not done. | ||
| SECONDARY | Change in the Percentage of Cells With Normal and Abnormal Myeloid Phenotype Measured by Flow Cytometry | Baseline and 6, 12, 24, and 36 weeks | Due to the limited number of clinical responders, the research assay was not done. |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response (Complete and Partial Response) in Patients With Myeloid Disorders | Arm I | Complete Remission (CR) | 0 | Participants | |
| Response (Complete and Partial Response) in Patients With Myeloid Disorders | Arm I | Partial Remission (PR) | 1 | Participants | |
| Response (Complete and Partial Response) in Patients With Myeloid Disorders | Arm I | Hematologic Improvement in Neutrophils (HI-N) | 2 | Participants | |
| Response (Complete and Partial Response) in Patients With Myeloid Disorders | Arm I | Stable Disease (SD) | 5 | Participants | |
| Response (Complete and Partial Response) in Patients With Myeloid Disorders | Arm I | Progressive Disease (PD) | 2 | Participants | |
| Clinical Activity Assessed by Change in Peripheral Blood Counts | Arm I | ANC +/- SEM at baseline | 578 | Standard Error 126 | cell/mm^3 |
| Clinical Activity Assessed by Change in Peripheral Blood Counts | Arm I | ANC +/- SEM after 2 cycles | 1137 | Standard Error 384 | cell/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 | Arm I | 24 | |
| Overall Study | COMPLETED | Arm I | 10 | |
| Overall Study | NOT COMPLETED | Arm I | 14 |
Source ClinicalTrials.gov
Adverse events20
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 | Muscle weakness | Musculoskeletal and connective tissue disorders | Arm I | 2 | 24 | |
| other | hyponatremia | Metabolism and nutrition disorders | Arm I | 2 | 24 | |
| other | confusion | Nervous system disorders | Arm I | 2 | 24 | |
| other | Neutropenic infection | Infections and infestations | Arm I | 1 | 24 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Arm I | 1 | 24 | |
| other | fatigue | General disorders | Arm I | 1 | 24 | |
| other | back pain | Musculoskeletal and connective tissue disorders | Arm I | 1 | 24 | |
| other | hypocalcemia | Metabolism and nutrition disorders | Arm I | 1 | 24 | |
| other | GI bleed | Gastrointestinal disorders | Arm I | 1 | 24 | |
| serious | Neutropenic infection | Infections and infestations | Arm I | 5 | 24 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I | ||
| Total, other adverse events | Arm I | 6 | 24 |
| Total, serious adverse events | Arm I | 19 | 24 |
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 |
|---|---|---|---|---|---|
| U01CA070095 | Phase I Clinical Trials of New Anti-Cancer Targeted Therapies | CARDUCCI, MICHAEL A | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1995 to 2013 |
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/NCT00462605
GET https://conductscience.org/api/trials/v1/NCT00462605/registered