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 range1 Year – 21 Years
SexALL
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
✓. 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.)
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 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.