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NCT01743807 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia
A Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01743807: Clinical Trial Phase 1 study, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
NCT01743807 is a Phase 1 study that was terminated before completion, run by Therapeutic Advances in Childhood Leukemia Consortium. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01743807, a Phase 1 study, was terminated before completion, sponsored by Therapeutic Advances in Childhood Leukemia Consortium.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who are in morphologic remission but are positive for Minimum Residual Disease (MRD).
Primary Outcome
DLT is defined as: A) Any non-hematologic toxicity that is ≥ CTCAE grade 3 and at least possibly related to GNKG168 (the relationship to GNKG168 cannot be ruled out), with the EXCEPTION of the following toxicities when observed at Grade 3: * Fatigue * Fever * Anorexia * Rash that turns to grade ≤ 2 within 7 days * Elevation in hepatic transaminases (ALT/SGOT and AST/SGPT), GGT or alkaline phosphatase that returns to ≤ grade 2 within 14 days. It will not be considered a DLT if the patient exits
Interventions
- DRUG GNKG168
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-03-26 |
| Est. Completion | 2014-07-28 |
| Phase | Phase 1 |
Why NCT01743807 stopped before completion
NCT01743807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which GNKG168 is the first listed.
NCT01743807 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01743807 about?
NCT01743807 is a clinical study titled "Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia". This is a phase I trial of an investigational drug called GNKG168 in patients with relapsed and refractory acute lymphoblastic leukemia (ALL) and acute myelogenous leukemia (AML) who are in morphologic remission but are positive for Minimum Residual Disease (MRD).
What is the current status of trial NCT01743807?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2014-03-26. Estimated completion is 2014-07-28.
What interventions are being tested in trial NCT01743807?
The interventions under investigation include: GNKG168 (DRUG).
Who is sponsoring clinical trial NCT01743807?
This trial is sponsored by Therapeutic Advances in Childhood Leukemia Consortium, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01743807's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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