Trial · NCT00618540
Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis
NCT00618540, Phase 2, Terminated, Masonic Cancer Center, University of Minnesota; results first posted 2015-11-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis. Trials, record NCT00618540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00618540
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis
- NCT number
- NCT00618540
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Histiocytosis, Langerhans-cell
- Interventions
- alemtuzumab, fludarabine phosphate, melphalan, stem cell transplantation
- First posted
- 2008-02-20
- Last updated
- 2017-12-28
- Results first posted
- 2015-11-03
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | Year 1, Year 3 | Count of patients alive at 1 and 3 years. Deaths from any cause are events. Surviving patients are censored at the date of last contact. |
| Primary | Disease-free Survival at 12 Months Post Transplantation | Year 1 | This outcome is defined as survival with resolution of LCH at 12 months post transplant. Unresolved disease for over 12 months post-transplant, progressive disease after this time period, recurrence of disease and death from any cause are considered events. Those who survive with resolution of disease are censored at the date of last contact. |
| Secondary | Transplantation-related Death | Day 100 | Count of patients who died by day 100 related to the transplantation. |
| Secondary | Neutrophil Engraftment | Day 100 | Incidence of neutrophil recovery and donor chimerism at Day 100. |
| Secondary | Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) | Day 100 and Month 6 | The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive \<21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant. |
| Secondary | Incidence of Chronic GVHD | Day 100 and Month 6 | Occurrence of symptoms in any organ system fulfilling the criteria of limited or extensive chronic GvHD (Appendix III), among patients surviving \> 90 days with evidence of engraftment. Patients without chronic GvHD will be censored at time of death or last follow-up. |
| Secondary | Platelet Engraftment | Day 100 | Incidence of platelet recovery and donor chimerism at Day 100. |
| Secondary | Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) | Day 100 and Month 6 | The occurrence of skin, gastrointestinal or liver abnormalities fulfilling the criteria of Grades II, III and/or IV acute GVHD are considered events (Appendix II). Patients without acute GvHD will be censored at the time of death or last follow-up. Patients that survive \<21 days and listed as not evaluable will be excluded. Patients receiving a second transplant will be censored at the time of second transplant. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | Year 1, Year 3 | participants | NUMBER | |
| PRIMARY | Disease-free Survival at 12 Months Post Transplantation | Year 1 | participants | NUMBER | |
| SECONDARY | Transplantation-related Death | Day 100 | participants | NUMBER | |
| SECONDARY | Neutrophil Engraftment | Day 100 | participants | NUMBER | |
| SECONDARY | Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) | Day 100 and Month 6 | participants | NUMBER | |
| SECONDARY | Incidence of Chronic GVHD | Day 100 and Month 6 | participants | NUMBER | |
| SECONDARY | Platelet Engraftment | Day 100 | participants | NUMBER | |
| SECONDARY | Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) | Day 100 and Month 6 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Alemtuzumab Conditioning | 0 | participants | ||
| Disease-free Survival at 12 Months Post Transplantation | Alemtuzumab Conditioning | 0 | participants | ||
| Transplantation-related Death | Alemtuzumab Conditioning | 0 | participants | ||
| Neutrophil Engraftment | Alemtuzumab Conditioning | 1 | participants | ||
| Incidence of Grade II-IV Acute Graft-versus-host-disease (GVHD) | Alemtuzumab Conditioning | 1 | participants | ||
| Incidence of Chronic GVHD | Alemtuzumab Conditioning | 0 | participants | ||
| Platelet Engraftment | Alemtuzumab | 0 | participants | ||
| Incidence of Grade III-IV Acute Graft-versus-host-disease (GVHD) | Alemtuzumab Conditioning | 0 | 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 Conditioning | 1 | |
| Overall Study | COMPLETED | Alemtuzumab Conditioning | 1 | |
| Overall Study | NOT COMPLETED | Alemtuzumab Conditioning | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Multiple systemic infections | Infections and infestations | Alemtuzumab Conditioning | 1 | 1 | |
| serious | Respiratory syncytial virus (RSV) infection | Respiratory, thoracic and mediastinal disorders | Alemtuzumab Conditioning | 1 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alemtuzumab Conditioning | ||
| Total, other adverse events | Alemtuzumab Conditioning | 1 | 1 |
| Total, serious adverse events | Alemtuzumab Conditioning | 1 | 1 |
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/NCT00618540
GET https://conductscience.org/api/trials/v1/NCT00618540/registered