Therapeutic Advances in Childhood Leukemia Consortium
Who can join
Adults 1 to 21, any sex, with Relapsed Acute Lymphoblastic Leukemia or Relapsed Acute Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Dose Limiting Toxicity (DLT) in the First Two Courses of TherapyPrimary· Beginning with the first dose of GNKG168 until the end of course 2; courses are 14 days so there will be approximately 28 days of monitoring for DLT
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 the study and begins alternative therapy before the end of the 14 day evaluation period.
B) Grade
Group
Value
95% CI
Post HSCT- Dose Level 0
0
Post HSCT- Dose Level 1
0
Post HSCT- Dose Level 2
0
Post HSCT- Dose Level 3
0
No HSCT- Dose Level 0
0
No HSCT- Dose Level 1
0
No HSCT- Dose Level 2
0
No HSCT- Dose Level 3
0
The Number of Participants With a Decrease in Minimal Residual Disease (MRD) Present in Patients Treated With GNKG168Secondary· Pre-study and End of Course 1 (Day 14)
Doctors have developed a test to detect very small amounts of leukemia that still exist even though it looks like remission under a microscope. This test is called Minimal Residual Disease (MRD). MRD is very specific and can detect 1 cancer cell out of 10,000 regular cells. The results of the MRD test on bone marrow can show when a patient has a very small amount of cancer cells left in the bone marrow. We will use this test to evaluate the effect of GNKG168 in killing the small amount of cells left in your bone marrow.
Group
Value
95% CI
HSCT- Dose Level 0
0
HSCT- Dose Level 1
0
HSCT- Dose Level 2
0
HSCT- Dose Level 3
0
No HSCT- Dose Level 0
0
No HSCT- Dose Level 1
0
No HSCT- Dose Level 2
0
No HSCT- Dose Level 3
0
Occurrence of Graft Versus Host Disease (GVHD) in Patients Who Had Previous HSCT and Received GNKG168Secondary· Weekly during Courses 1 and 2 (i.e, 4 times in 28 days), Day 1 of Courses 3-6 (approximately Days 29, 43 and 57), and when patient is removed from protocol therapy.
We will evaluate the impact of GNKG168 on induction of clinical GVHD using the consensus scoring system developed by NIH (Filipovich et. al., National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. Diagnosis and Staging Working Group Report, Biology of Blood and Marrow Transplantation, Volume 11, Issue 12, Dec. 2005, pp. 945-956)
Group
Value
95% CI
HSCT- Dose Level 0
0
HSCT- Dos level1
0
HSCT- Dose Level 2
0
HSCT- Dose Level 3
0
No HSCT- Dose Level 0
0
No HSCT- Dose Level 1
0
No HSCT- Dose Level 2
0
No HSCT- Dose Level 3
0
Adverse events — posted to ClinicalTrials.gov
Time frame: AEs were collected from the first dose of study therapy until 30 days after the last dose of study therapy. Therefore, for a given patient, AEs could be captured for 30-114 days depending on the length of time the patient received therapy..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Therapeutic Advances in Childhood Leukemia Consortium
Last refreshed: 27 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01743807.