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NCT00038051 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Anti-CD-33 Immunotoxin Hum-195/rGel in Patients With Advanced Myeloid Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT00038051: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT00038051 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00038051, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to find the highest safe dose of the anti-CD33 immunotoxin HuM-195/rGel that can be given to patients with advanced myeloid malignancies. This treatment will be given to patients whose leukemia has not responded to prior chemotherapy.
Primary Outcome
Dose-limiting toxicity considered to have occurred when (1) \>grade 2 extramedullary toxicity possibly related to HuM195/rGel (except nausea, vomiting or diarrhea unless uncontrolled by optimal management, or electrolyte abnormalities unless clinically significant or not correctable after optimal replacement) is observed or (2) \>42 days from day 1 of therapy elapse before return of neutrophil count to \>500 and platelet count to \>25,000 in absence of leukemia (i.e., with a normal or hypercellu
Interventions
- DRUG Hum-195/rGel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 1999-05 |
| Est. Completion | 2013-02 |
| Phase | Phase 1 |
What the finished NCT00038051 record still lists
NCT00038051 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Hum-195/rGel is the first listed.
NCT00038051 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00038051 about?
NCT00038051 is a clinical study titled "Evaluation of the Anti-CD-33 Immunotoxin Hum-195/rGel in Patients With Advanced Myeloid Malignancies". The goal of this clinical research study is to find the highest safe dose of the anti-CD33 immunotoxin HuM-195/rGel that can be given to patients with advanced myeloid malignancies. This treatment will be given to patients whose leukemia has not responded to prior chemotherapy.
What is the current status of trial NCT00038051?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 1999-05. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00038051?
The interventions under investigation include: Hum-195/rGel (DRUG).
Who is sponsoring clinical trial NCT00038051?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00038051's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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