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Protocol No.1567GCCPrincipal InvestigatorBaer, Maria
PhasePhase I/II (Cancer Control)
Age GroupAdult
TitleA Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 in Adult Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL)
TreatmentThe sponsor is testing an experimental treatment named KTE-C19, which uses the patient’s own genetically altered (changed) blood cells to treat cancer.
Key Eligibility-Relapsed or refractory B-precursor ALL
- Ph+ disease eligible if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have relapsed/refractory disease despite treatment with at least 2 different TKIs
-ECOG performance status of 0 or 1
-ANC >= 500/uL unless in the opinion of the PI cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy
-Platelet count >= 50,000/uL unless in the opinion of the PI cytopenia is due to underlying leukemia and is potentially reversible with leukemia therapy
-Absolute lymphocyte count >=100/uL
-Adequate renal, hepatic, pulmonary and cardiac function
-In subjects previously treated with blinatumomab, CD19 tumor expression on blast obtained from bone marrow or peripheral blood must be documented after completion of the most recent prior line of therapy. If CD19 expression is quantified, then blast must be >= 90% CD19 positive blasts.
-Negative pregnancy test

For detailed eligibility please visit the clinicaltrials.gov weblink below
Applicable Disease SitesAcute Lymphoblastic Leukemia
Therapies InvolvedChemotherapy (NOS)
Immunotherapy
Drugs InvolvedKTE-C19
cyclophosphamide
fludarabine
StatusOpen
Treatment TypeTreatment
ClinicalTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT02614066
ContactGreenebaum Comprehensive Cancer Center: Emade Ebah, MPH Phone:
Pager:
Email:Emade.Ebah@umm.edu
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