Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia (NCT01743807) | Clinical Trial Compass
TerminatedPhase 1
Phase I Study of GNKG168 in Acute Lymphoblastic Leukemia and Acute Myelogenous Leukemia
Stopped: SBI Biotech (supplier) decided to no longer support the study or GNKG168.
United States4 participantsStarted 2014-03-26
Plain-language 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).
Who can participate
Age range
1 Year – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age Patients must be ≥1 and ≤ 21 years of age when originally diagnosed with ALL or AML.
. Diagnosis
. Patients must have previously histologically confirmed ALL or AML at original diagnosis or previous relapse. Patients with treatment-related AML are eligible.
. Patients must be in complete remission (CR) with less than 5% blasts in the bone marrow.
. Patient must have detectable MRD (≥0.01%) by flow cytometry.
. Performance Level Karnofsky ≥ 50% for patients \>16 years of age and Lansky ≥ 50% for patients ≤16 years of age.
. Prior Therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Dose Limiting Toxicity (DLT) in the First Two Courses of Therapy
Timeframe: 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
Trial details
NCT IDNCT01743807
SponsorTherapeutic Advances in Childhood Leukemia Consortium
. Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy.
Exclusion criteria
. Graft versus host disease (GVHD) that meets the following criteria:
. Active grade 2 or higher acute GVHD at the time of study entry.
. Active chronic GVHD (moderate or severe).
. Plan for donor lymphocyte infusions during the study period.
. Need for immunosuppressive medications including high-dose corticosteroids (prednisone \>0.5 mg/kg or equivalent) (Note: low-dose steroid; prednisone ≤0.5 mg/kg/day or equivalent is allowed.)
. Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
. Patient will be excluded if they are currently receiving other investigational drugs.
. Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.