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NCT02338050 · ClinicalTrials.gov registry record · Phase 2
Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study, sponsored by Center for International Blood and Marrow Transplant Research.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT02338050: Clinical Trial Phase 2 study, sponsored by Center for International Blood and Marrow Transplant Research.
NCT02338050 is a Phase 2 study that was terminated before completion, run by Center for International Blood and Marrow Transplant Research. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02338050, a Phase 2 study, was terminated before completion, sponsored by Center for International Blood and Marrow Transplant Research.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a phase II, open-label, nonrandomized, prospective study to evaluate the activity, safety, and feasibility of administration of moxetumomab pasudotox in the pre-allogeneic hematopoietic cell transplantation (HCT) setting to patients with B-lineage Acute Lymphoblastic Leukemia (ALL) who are in a morphologic complete remission and have pre-transplant minimal residual disease (MRD) \> 0.01% (detected by flow cytometry). The primary objective of this study is to determine if treatment with moxetumomab pasudotox in the MRD positive setting is able to lead to MRD negativity (\< 0.01% by flow cytometry) or at least a 1-log10 reduction in MRD prior to allogeneic HCT.
Primary Outcome
The primary endpoint is the event of whether patients successfully achieved either MRD negativity (defined as \<0.01%) or at least 1 log10 reduction in MRD levels using flow cytometry via central laboratory testing after moxetumomab treatment but prior to HCT relative to pre-moxetumomab MRD measurement (baseline). The proportion of patients who become MRD negative or who have at least a 1-log10 reduction from baseline will be summarized and 80% confidence intervals will provided. An exploratory
Interventions
- BIOLOGICAL Moxetumomab Pasudotox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-05 |
| Phase | Phase 2 |
Why NCT02338050 stopped before completion
NCT02338050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Moxetumomab Pasudotox is the first listed.
NCT02338050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02338050 about?
NCT02338050 is a clinical study titled "Moxetumomab Pasudotox (CAT-8015, HA22) in Children With B-lineage Acute Lymphoblastic Leukemia and Minimal Residual Disease Prior to Allogeneic Hematopoietic Stem Cell Transplantation". This is a phase II, open-label, nonrandomized, prospective study to evaluate the activity, safety, and feasibility of administration of moxetumomab pasudotox in the pre-allogeneic hematopoietic cell transplantation (HCT) setting to patients with B-lineage Acute Lymphoblastic Leukemia (ALL) who are i...
What is the current status of trial NCT02338050?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2015-05.
What interventions are being tested in trial NCT02338050?
The interventions under investigation include: Moxetumomab Pasudotox (BIOLOGICAL).
Who is sponsoring clinical trial NCT02338050?
This trial is sponsored by Center for International Blood and Marrow Transplant Research, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02338050's enrollment target sits among peer trials
1 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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