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NCT01829711 · ClinicalTrials.gov registry record · Phase 3
Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia
A Phase 3 study, sponsored by MedImmune.
- Completed
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT01829711: Completed Phase 3 study, sponsored by MedImmune.
NCT01829711 is a Phase 3 study that has completed, run by MedImmune. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01829711, a Phase 3 study, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
Study Summary
Background: \- Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I trial it had activity in relapsed/refractory hairy cell leukemia with safety profile supporting further clinical study (http://ncbi.nlm.nih.gov/pubmed/22355053). This is a phase III multicenter trial designed to confirm these results.
Primary Outcome
Durable CR was defined as overall response that meets blood, bone marrow and imaging criteria for CR, followed by a \>180 day duration of hematologic remission (HR). CR requires all of the following to be present: No evidence of leukemic cells in peripheral blood and/or by routine H/E staining of bone marrow; Resolution of any hepatomegaly, splenomegaly, and abnormal (\>= 2 cm minimum length) lymphadenopathy by CT or MRI (maximum diameter of spleen should be either \< 17 cm or have decreased by
Interventions
- DRUG Moxetumomab pasudotox
- DRUG IV Bag Protectant for Moxetumomab pasudotox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-04-29 |
| Est. Completion | 2019-04-29 |
| Phase | Phase 3 |
What the finished NCT01829711 record still lists
NCT01829711 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Moxetumomab pasudotox is the first listed.
NCT01829711 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01829711 about?
NCT01829711 is a clinical study titled "Moxetumomab Pasudotox for Advanced Hairy Cell Leukemia". Background: \- Moxetumomab pasudotox is an experimental non-chemotherapy cancer treatment drug. It targets CD22, a molecule on the surface of essentially all hairy cell leukemia cells. Moxetumomab pasudotox binds to CD22, goes into the cell, and releases a toxin which kills the cell. In a phase I t...
What is the current status of trial NCT01829711?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2013-04-29. Estimated completion is 2019-04-29.
What interventions are being tested in trial NCT01829711?
The interventions under investigation include: Moxetumomab pasudotox (DRUG), IV Bag Protectant for Moxetumomab pasudotox (DRUG).
Who is sponsoring clinical trial NCT01829711?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01829711's enrollment target sits among peer trials
80 1755th of 2000 higher than 233 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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