Trial · NCT00548847
Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation
NCT00548847, Phase 2, Completed, Emory University; results first posted 2016-08-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation. Trials, record NCT00548847. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00548847
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Immunotherapy for Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Blast Phase Chronic Myelogenous Leukemia (BP CML), and Myelodysplastic Syndrome (MDS) Relapse After Allogeneic Transplantation
- NCT number
- NCT00548847
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Leukemia
- Interventions
- GM-CSF, Interferon-α-2b
- First posted
- 2007-10-24
- Last updated
- 2016-10-26
- Results first posted
- 2016-08-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy of GM-CSF and Pegylated Interferon-alpha 2b When Administered to Patients With AML, ALL, Blast Phase CML, and MDS Relapse After Allogeneic Transplantation, Defined as Progression-free Survival of > 33% at 3 Months | 3 months after cytokine treatment | Efficacy is defined as progression-free survival of \> 33% at 3 months. This is based on our retrospective data on 10% 3 month survival for relapsed patients. Progression is defined an an increase in blasts in blood or marrow by 50% compared to baseline with at least 20% of all cells being blasts at the time of assessment. |
| Secondary | Overall Survival at 6 Months (Evaluate Overall Responses; Perform Lab Experiments to Test Hypothesis That Exposure to Interferon-alpha and GM-CSF Up-regulates Co-stimulatory Molecule Expression on Relapsed Acute Leukemia Cells) | 6 months after cytokine treatment |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy of GM-CSF and Pegylated Interferon-alpha 2b When Administered to Patients With AML, ALL, Blast Phase CML, and MDS Relapse After Allogeneic Transplantation, Defined as Progression-free Survival of > 33% at 3 Months | 3 months after cytokine treatment | percentage of progression-free patients | NUMBER | |
| SECONDARY | Overall Survival at 6 Months (Evaluate Overall Responses; Perform Lab Experiments to Test Hypothesis That Exposure to Interferon-alpha and GM-CSF Up-regulates Co-stimulatory Molecule Expression on Relapsed Acute Leukemia Cells) | 6 months after cytokine treatment | participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Efficacy of GM-CSF and Pegylated Interferon-alpha 2b When Administered to Patients With AML, ALL, Blast Phase CML, and MDS Relapse After Allogeneic Transplantation, Defined as Progression-free Survival of > 33% at 3 Months | GM-CSF, Interferon-α-2b | 13 | percentage of progression-free patients | ||
Overall Survival at 6 Months (Evaluate Overall Responses; Perform Lab Experiments to Test Hypothesis That Exposure to Interferon-alpha and GM-CSF Up-regulates Co-stimulatory Molecule Expression on Relapsed Acute Leukemia Cells) | GM-CSF, Interferon-α-2b | 2 | 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 | GM-CSF, Interferon-α-2b | 15 | |
| Overall Study | COMPLETED | GM-CSF, Interferon-α-2b | 8 | |
| Overall Study | NOT COMPLETED | GM-CSF, Interferon-α-2b | 7 |
Source ClinicalTrials.gov
Adverse events11
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 | Fever | General disorders | GM-CSF, Interferon-α-2b | 1 | 15 | |
| other | Myalgia | Musculoskeletal and connective tissue disorders | GM-CSF, Interferon-α-2b | 1 | 15 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | GM-CSF, Interferon-α-2b | 1 | 15 | |
| other | Malaise | General disorders | GM-CSF, Interferon-α-2b | 1 | 15 | |
| other | Bone Pain | Musculoskeletal and connective tissue disorders | GM-CSF, Interferon-α-2b | 1 | 15 | |
| other | Nausea | General disorders | GM-CSF, Interferon-α-2b | 1 | 15 | |
| serious | Death | General disorders | GM-CSF, Interferon-α-2b | 5 | 15 | |
| serious | Dyspnea | Respiratory, thoracic and mediastinal disorders | GM-CSF, Interferon-α-2b | 1 | 15 | |
| serious | Infection | Infections and infestations | GM-CSF, Interferon-α-2b | 2 | 15 | |
| serious | Hemorrhage | Blood and lymphatic system disorders | GM-CSF, Interferon-α-2b | 1 | 15 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GM-CSF, Interferon-α-2b | ||
| Total, other adverse events | GM-CSF, Interferon-α-2b | 6 | 15 |
| Total, serious adverse events | GM-CSF, Interferon-α-2b | 8 | 15 |
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/NCT00548847
GET https://conductscience.org/api/trials/v1/NCT00548847/registered