Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00618540 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00618540: Clinical Trial Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00618540 is a Phase 2 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00618540, a Phase 2 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
RATIONALE: Giving a monoclonal antibody, such as alemtuzumab, and chemotherapy drugs, such as fludarabine and melphalan, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of abnormal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving alemtuzumab together with fludarabine and melphalan followed by a donor stem cell transplant works in treating young patients with resistant Langerhans cell histiocytosis.
Primary Outcome
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.
Interventions
- DRUG fludarabine phosphate
- BIOLOGICAL alemtuzumab
- DRUG melphalan
- PROCEDURE stem cell transplantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2007-01 |
| Est. Completion | 2013-05 |
| Phase | Phase 2 |
Why NCT00618540 stopped before completion
NCT00618540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which fludarabine phosphate is the first listed.
NCT00618540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00618540 about?
NCT00618540 is a clinical study titled "Reduced Intensity Hematopoietic Cell Transplantation for Patients With Resistant Langerhans Cell Histiocytosis". RATIONALE: Giving a monoclonal antibody, such as alemtuzumab, and chemotherapy drugs, such as fludarabine and melphalan, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of abnormal cells. When the healthy stem...
What is the current status of trial NCT00618540?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2007-01. Estimated completion is 2013-05.
What interventions are being tested in trial NCT00618540?
The interventions under investigation include: fludarabine phosphate (DRUG), alemtuzumab (BIOLOGICAL), melphalan (DRUG), stem cell transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT00618540?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00618540's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia