Trial · NCT02385110
Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
NCT02385110, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2024-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis. Trials, record NCT02385110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02385110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis
- NCT number
- NCT02385110
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Leukemia
- Interventions
- Alemtuzumab, Etoposide, Dexamethasone, Methotrexate, Phone Call, Tocilizumab
- First posted
- 2015-03-11
- Last updated
- 2024-01-17
- Results first posted
- 2024-01-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With a Response to Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis | 8 weeks | Response is defined as complete response (CR) and/or partial response (PR) and/or parameter improvements (PI). Complete response (CR) is normalization to within institutional normal limits of diagnostic clinical and laboratory abnormalities associated with HLH. In the case of ferritin, normalization OR a 3 fold improvement in the pre-study level will be evidence of complete response, provided the post therapy level is also below 10000 ng/ml. Partial response (PR) is sustained normalization of 3 or more of the diagnostic clinical and laboratory abnormalities noted above (or, with ferritin, improvement as described above) and no apparent progression of other aspects of disease pathology. Parameter improvements (PI) is at least a 25% improvement in two or more quantifiable symptoms and/or laboratory markers from those mentioned above within 8 weeks (+/- 7 days) of initiation of therapy. |
| Primary | Disease Free Survival | 8 weeks | Time from date of treatment start until the date of first objective documentation of disease-relapse. |
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 | Number of Participants With a Response to Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis | 8 weeks | Of the two participants in Group 1, only one participant was evaluable for response. Of the sixteen participants in Group 2, only eight were evaluable for response. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Disease Free Survival | 8 weeks | Of the two participants in Group 1, only one participant was evaluable for response. Of the 16 participants in Group 2, only eight were evaluable for response. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With a Response to Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | Participants | ||
| Number of Participants With a Response to Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis | Group 2: Etoposide + Dexamethasone + Tocilizumab | 8 | Participants | ||
| Disease Free Survival | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1.9 | Months | ||
| Disease Free Survival | Group 2: Etoposide + Dexamethasone + Tocilizumab | 1.9 | Full Range 0.8 to 5.0 | Months |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 2 | |
| Overall Study | STARTED | Group 2: Etoposide + Dexamethasone + Tocilizumab | 16 | |
| Overall Study | COMPLETED | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | |
| Overall Study | COMPLETED | Group 2: Etoposide + Dexamethasone + Tocilizumab | 16 | |
| Overall Study | NOT COMPLETED | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | |
| Overall Study | NOT COMPLETED | Group 2: Etoposide + Dexamethasone + Tocilizumab | 0 |
Source ClinicalTrials.gov
Adverse events110
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 | Hyperglycemia | Metabolism and nutrition disorders | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | 2 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Group 2: Etoposide + Dexamethasone + Tocilizumab | 4 | 16 | 4 |
| other | Catheter Related Deep Vein Thrombosis | Vascular disorders | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | 2 | 1 |
| other | Catheter Related Deep Vein Thrombosis | Vascular disorders | Group 2: Etoposide + Dexamethasone + Tocilizumab | 0 | 16 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | 2 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Group 2: Etoposide + Dexamethasone + Tocilizumab | 0 | 16 | 0 |
| other | Fever | General disorders | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | 2 | 1 |
| other | Fever | General disorders | Group 2: Etoposide + Dexamethasone + Tocilizumab | 6 | 16 | 6 |
| other | Fatigue | General disorders | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | 2 | 1 |
| other | Fatigue | General disorders | Group 2: Etoposide + Dexamethasone + Tocilizumab | 4 | 16 | 4 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | 2 |
| Total, all-cause mortality | Group 2: Etoposide + Dexamethasone + Tocilizumab | 7 | 16 |
| Total, other adverse events | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 2 | 2 |
| Total, other adverse events | Group 2: Etoposide + Dexamethasone + Tocilizumab | 16 | 16 |
| Total, serious adverse events | Group 1: Alemtuzumab + Etoposide + Dexamethasone | 1 | 2 |
| Total, serious adverse events | Group 2: Etoposide + Dexamethasone + Tocilizumab | 9 | 16 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Group 1: Alemtuzumab + Etoposide + Dexamethasone vs Group 2: Etoposide + Dexamethasone + Tocilizumab: Number of Participants With a Response to Alemtuzumab or Tocilizumab in Combination With Etoposide and Dexamethasone for the Treatment of Adult Patients With Hemophagocytic Lymphohistiocytosis | Trial comparisons |
| Group 1: Alemtuzumab + Etoposide + Dexamethasone vs Group 2: Etoposide + Dexamethasone + Tocilizumab: deaths from any cause | Trial comparisons |
| Group 1: Alemtuzumab + Etoposide + Dexamethasone vs Group 2: Etoposide + Dexamethasone + Tocilizumab: serious adverse events | Trial comparisons |
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/NCT02385110
GET https://conductscience.org/api/trials/v1/NCT02385110/events?page=2