Trial · NCT01191749
Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)
NCT01191749, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2017-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL). Trials, record NCT01191749. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01191749
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alemtuzumab in Myelodysplastic Syndrome (MDS), Aplastic Anemia, and T-Cell Large Granular Lymphocytic Leukemia (T-GL)
- NCT number
- NCT01191749
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Alemtuzumab
- First posted
- 2010-08-31
- Last updated
- 2017-05-09
- Results first posted
- 2017-05-09
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 - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria | Up to 6 months following treatment; response assessed every 2 months | Overall response (OR) defined as complete/partial remission for at least 4 weeks or hematologic improvement for at least 8 weeks. Response Criteria are according to the Modified IWG Response Criteria in Myelodysplasia. IWG 2006 response criteria - CR: bone marrow evaluation shows less than or equal to (\<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin \>= 11 gram per deciliter (g/dL), neutrophils \>= 1000/mL, platelets \>= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by \>=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count \<100 x 10\^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10\^9/L. |
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 - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria | Up to 6 months following treatment; response assessed every 2 months | One subject's response was indeterminate due to the absence of end of therapy assessments. | 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 |
|---|---|---|---|---|---|
| Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria | Alemtuzumab | Complete Remission (CR) | 0 | participants | |
| Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria | Alemtuzumab | Partial Remission (PR) | 0 | participants | |
| Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria | Alemtuzumab | Hematologic Improvement | 1 | participants | |
| Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria | Alemtuzumab | Disease Progression | 1 | participants | |
| Overall Response - Number of Participants Who Achieved Complete Remission (CR)+Partial Remission (PR) - as Per International Working Group (IWG) Response Criteria | Alemtuzumab | Stable Disease (SD) | 4 | 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 | Alemtuzumab | 7 | |
| Overall Study | COMPLETED | Alemtuzumab | 7 | |
| Overall Study | NOT COMPLETED | Alemtuzumab | 0 |
Source ClinicalTrials.gov
Adverse events13
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 | Urinary Tract Infection | Renal and urinary disorders | Alemtuzumab | 1 | 7 | 1 |
| other | Hives | Skin and subcutaneous tissue disorders | Alemtuzumab | 1 | 7 | 1 |
| other | Mucositis | Gastrointestinal disorders | Alemtuzumab | 1 | 7 | 1 |
| other | Nausea and Vomiting | Gastrointestinal disorders | Alemtuzumab | 2 | 7 | 2 |
| other | Hypotension | Cardiac disorders | Alemtuzumab | 1 | 7 | 1 |
| other | Elevated ALT | Metabolism and nutrition disorders | Alemtuzumab | 1 | 7 | 1 |
| other | Elevated AST | Metabolism and nutrition disorders | Alemtuzumab | 1 | 7 | 1 |
| other | Chills | General disorders | Alemtuzumab | 1 | 7 | 1 |
| other | Headache | Nervous system disorders | Alemtuzumab | 1 | 7 | 1 |
| serious | Bacteremia | Infections and infestations | Alemtuzumab | 1 | 7 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alemtuzumab | ||
| Total, other adverse events | Alemtuzumab | 7 | 7 |
| Total, serious adverse events | Alemtuzumab | 1 | 7 |
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/NCT01191749
GET https://conductscience.org/api/trials/v1/NCT01191749/registered