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Brief Title L-asparaginase Encapsulated in Red Blood Cells for Frontline Therapy of Patients With Phi-neg ALL Older Than 40 yo
Official Title Phase I Study of L-asparaginase Encapsulated in RBC (ERYASP) in Combination With the CALGB Regimen During Induction and Consolidation Phases for Frontline Therapy of Patients Older Than 40 Years With Philadelphia Chromosome-negative ALL
Principal Investigator Larson, Richard
Brief Summary Asparaginase (Asp) is used during the induction phase of ALL treatment for children and young adults. Its efficacy is counterbalanced by its, mainly in patients 40 years or older. The efficacy rate in older adult population is lower than for children or young adults. A recent review on outcomes in older adults with ALL pointed out that there were significantly more drug reductions, omissions or delays in the older group as compared to younger adults and that asparaginase was the drug most commonly omitted. The investigational product ERYASP is a suspension of homologous red blood cells (RBC) encapsulating E. coli Asp. A previous European phase I/II clinical study in children and adults (<55 yo) at first relapse of ALL was conducted to determine the optimal dose of homologous RBC encapsulating native E. coli Asp (GRASPA®) in 24 patients with relapsed ALL. The activity and safety profiles of 3 doses of GRASPA® (50, 100 and 150 IU/kg) in combination with standard chemotherapy were compared to free native Asp. The global safety profile is also improved, reducing hypersensitivity, liver toxicity and coagulation disorders. Study showed that a single dose of GRASPA® 150 IU/kg induced a depletion in plasmatic asparagine for 18.6 days, i.e. similar to that obtained with 8 injections of 10,000 IU/m² of free native Asp. A reduction in the incidence and severity of the allergic reactions and coagulation disorders were observed with GRASPA® (Domenech 2011). a French phase II study designed to determine the maximum tolerated dose of GRASPA® in combination with a polychemotherapy regimen in ALL patients older than 55 yo at first diagnosis has been performed, and showed that both 100 and 150 IU/kg doses fulfilled the predefined criteria for efficacy and tolerability but the better profile of 100 IU/kg dose was considered the optimal dose in this setting. A phase II/III trial in adult and children patients with relapsed ALL is currently ongoing. ERYASP with the CALGB chemotherapy regimen could be an attractive combination of 1st line ALL therapy for adults 40 years or older in the USA. This phase I study evaluates tolerance of ERYASP in this frame using a dose titration design to confirm that the safety profile of ERYASP with the CALGB chemotherapy regimen is similar to that observed in the European chemotherapy regimen. PK/PD and immunogenicity parameters will also be evaluated.
Gender Both
Ages 40 Years
Enrollment 18
Accepts Healthy Volunteers No
Lead Sponsor ERYtech PharmaIndustry
Collaborator
Study Design Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1
Study Type Interventional
Contact Name Richard A LARSON, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Acute Lymphoblastic Leukemia
Detail for Health Professional (on clinicaltrials.gov)
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