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NCT01019876 · ClinicalTrials.gov registry record · Phase 2
Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT01019876: Completed Phase 2 study, sponsored by Columbia University.
NCT01019876 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01019876, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
This study proposes the use of a reduced intensity chemotherapy/radiation therapy regimen followed by stem cell transplantation, as compared to standard ablative chemotherapy regimens associated with stem cell transplantation, in a population of patients with non-malignant diseases (non-cancer). Eligible patients will have a non-malignant disease in one of the following four strata: bone marrow failure syndromes, immunodeficiencies, inborn errors of metabolism, or histiocytoses. Patients will be assigned to therapy according to diagnosis. Patients will be stratified by disease into one of four strata and treatment regimens will be based on specific disease criteria and conditions. Although these diseases are non-malignant in name, they are often malignant by nature of the disease progression, treatment and associated complications.
Primary Outcome
The number of participants with adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE - Version 4.0)
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Alemtuzumab
- DRUG Rabbit Anti-thymocyte Globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2002-09 |
| Est. Completion | 2021-09-07 |
| Phase | Phase 2 |
What the finished NCT01019876 record still lists
NCT01019876 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01019876 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01019876 about?
NCT01019876 is a clinical study titled "Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases". This study proposes the use of a reduced intensity chemotherapy/radiation therapy regimen followed by stem cell transplantation, as compared to standard ablative chemotherapy regimens associated with stem cell transplantation, in a population of patients with non-malignant diseases (non-cancer). Eli...
What is the current status of trial NCT01019876?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2002-09. Estimated completion is 2021-09-07.
What interventions are being tested in trial NCT01019876?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Alemtuzumab (DRUG), Rabbit Anti-thymocyte Globulin (DRUG).
Who is sponsoring clinical trial NCT01019876?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01019876's enrollment target sits among peer trials
38 1467th of 2000 higher than 517 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
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