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NCT00531310 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity AlloSCT in(CML) With Persistent Disease
A Phase 2 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00531310: Clinical Trial Phase 2 study, sponsored by Columbia University.
NCT00531310 is a Phase 2 study that was terminated before completion, run by Columbia University. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00531310, a Phase 2 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
CML, a malignant disorder of stem cells, is characterized by increases in both immature and mature myeloid, erythroid, and lymphoid cells, as well as platelets in the peripheral blood. The cytogenetic hallmark of CML is the Philadelphia(Ph)chromosome found in the malignant cells of 95% of patients. CML comprises 7-20% of all leukemias with an overall incidence in the general population estimated at 1 to 2 per 100,000. The peak incidence occurs in the fifth decade, however, all age groups, including children, are affected. The only reported environmental risk factor is exposure to excessive ionizing radiation that is documented in only a very small percentage of patients. Clinically, CML is characterized by an initial chronic phase in which patients may report mild constitutional symptoms; however, 40-50% are asymptomatic and are diagnosed based upon abnormal blood counts discovered during a routine examination. The chronic phase typically lasts three to five years, and is followed by an accelerated phase distinguished by progressive systemic symptoms, an increasing resistance to conventional chemotherapy, and a rise in the peripheral blood and bone marrow blast count. This evolves rapidly into a blastic crisis characterized by immature cells resembling the blasts characteristic of acute leukemia. The presence of 30% or more blastic cells in the blood or marrow is diagnostic of this final blastic phase which is typically fatal within 3 to 6 months. The primary treatment options for CML have traditionally been monotherapy with either busulfan or hydroxyurea. Both agents are able to control the clinical symptoms associated with CML, as well as induce hematological remissions in 80% of chronic phase patients. However, complete cytogenetic remissions with either agent are rare, and neither is able to prevent eventual progression to the terminal blastic phase; therefore, these therapies can only be considered palliative. The primary purpose of this clinical research tri
Interventions
- DRUG Reduced Intensity Conditioning, Busulfan and Fludarabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2003-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
Why NCT00531310 stopped before completion
NCT00531310 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Reduced Intensity Conditioning, Busulfan and Fludarabine is the first listed.
NCT00531310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00531310 about?
NCT00531310 is a clinical study titled "Reduced Intensity AlloSCT in(CML) With Persistent Disease". CML, a malignant disorder of stem cells, is characterized by increases in both immature and mature myeloid, erythroid, and lymphoid cells, as well as platelets in the peripheral blood. The cytogenetic hallmark of CML is the Philadelphia(Ph)chromosome found in the malignant cells of 95% of patients. ...
What is the current status of trial NCT00531310?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2003-01. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00531310?
The interventions under investigation include: Reduced Intensity Conditioning, Busulfan and Fludarabine (DRUG).
Who is sponsoring clinical trial NCT00531310?
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 NCT00531310's enrollment target sits among peer trials
5 2000th 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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