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NCT00004143 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes
A Phase 2 study, sponsored by David Rizzieri, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00004143: Completed Phase 2 study, sponsored by David Rizzieri, MD.
NCT00004143 is a Phase 2 study that has completed, run by David Rizzieri, MD. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004143, a Phase 2 study, has completed, sponsored by David Rizzieri, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem cell transplantation can also cure a variety of non-cancerous, inherited or acquired disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell transplantation is a risky procedure. For some non-cancerous conditions, the risks of this procedure outweigh the potential benefits. This protocol is designed to test a new approach to allogeneic stem cell transplantation. It is hoped that this approach will be better suited for patients with non-cancerous blood and bone marrow disorders.
Primary Outcome
Number of patients with neutrophil engraftment: Absolute Neutrophil Count (ANC) \> 500/μL and hemoglobin level remaining above 10 g/dL without transfusion support, with tests showing at least 2.5% donor cells present. Primary graft failure is defined as absence of establishment of adequate donor hematopoiesis by day 42 with bone marrow cellularity \< 5%, peripheral White Blood Count (WBC) \< 500/μL, peripheral ANC \< 100/μL, and/or platelets \< 10,000/μL by day 120 with absence of megakaryocytes
Interventions
- DRUG Campath, Chemo and/or TBI Allo SCT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 1999-09 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00004143 record still lists
NCT00004143 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Campath, Chemo and/or TBI Allo SCT is the first listed.
NCT00004143 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004143 about?
NCT00004143 is a clinical study titled "Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes". RATIONALE: Although used primarily to treat malignant disorders of the blood, allogeneic stem cell transplantation can also cure a variety of non-cancerous, inherited or acquired disorders of the blood. Unfortunately, the conventional approach to allogeneic stem cell transplantation is a risky proce...
What is the current status of trial NCT00004143?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 1999-09. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00004143?
The interventions under investigation include: Campath, Chemo and/or TBI Allo SCT (DRUG).
Who is sponsoring clinical trial NCT00004143?
This trial is sponsored by David Rizzieri, MD, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004143's enrollment target sits among peer trials
2 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
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