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NCT01020539 · ClinicalTrials.gov registry record · Phase 1
Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia
A Phase 1 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01020539: Completed Phase 1 study, sponsored by Columbia University.
NCT01020539 is a Phase 1 study that has completed, run by Columbia University. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01020539, a Phase 1 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
Allogeneic stem cell transplantation (AlloSCT) followed by targeted immune therapy Gemtuzumab Ozogamicin patients with acute myeloid leukemia (AML)/juvenile myelomonocytic leukemia (JMML)/myelodysplastic syndromes (MDS) will be safe and well tolerated.
Primary Outcome
To determine the maximal tolerated and/or biologically active dose of Gemtuzumab Ozogamicin (GO) (anti CD33 immunotoxin) therapy following reduced intensity (RI) allogeneic stem cell transplantation (alloSCT) in patients with average risk AML/JMML/MDS.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Gemtuzumab Ozogamicin
- DRUG GVHD Prophylaxis
- DRUG Anti-Thymocyte Globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2002-09-11 |
| Est. Completion | 2020-12 |
| Phase | Phase 1 |
What the finished NCT01020539 record still lists
NCT01020539 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Fludarabine is the first listed.
NCT01020539 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01020539 about?
NCT01020539 is a clinical study titled "Allogeneic Stem Cell Transplantation Followed By Targeted Immune Therapy In Average Risk Leukemia". Allogeneic stem cell transplantation (AlloSCT) followed by targeted immune therapy Gemtuzumab Ozogamicin patients with acute myeloid leukemia (AML)/juvenile myelomonocytic leukemia (JMML)/myelodysplastic syndromes (MDS) will be safe and well tolerated.
What is the current status of trial NCT01020539?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2002-09-11. Estimated completion is 2020-12.
What interventions are being tested in trial NCT01020539?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Gemtuzumab Ozogamicin (DRUG), GVHD Prophylaxis (DRUG), Anti-Thymocyte Globulin (DRUG).
Who is sponsoring clinical trial NCT01020539?
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 NCT01020539's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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