Status:
TERMINATED
L-asparaginase Encapsulated in Red Blood Cells (Eryaspase) for Treatment of Adult Patients With ALL or LBL
Lead Sponsor:
ERYtech Pharma
Conditions:
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Asparaginase (Asp) is used during the induction phase of ALL treatment for children and young adults. Its efficacy is counterbalanced by its toxicity, mainly in patients 40 years or older. The efficac...
Detailed Description
A phase I study to assess the limiting toxicities, global safety and clinical activity of ERYASPASE, using a dose titration design to confirm that the safety profile of ERYASPASE in combination with t...
Eligibility Criteria
Inclusion
- Men and women aged 18 years and over
- Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
- Received no more than 1 prior treatment for ALL/LBL
- Note: Patients who have received transplant during 1st remission are excluded since this would be considered a 2nd treatment
- ECOG performance status 0-2
- Signed Informed Consent Form
Exclusion
- Other serious medical illness other than that treated by this study which would limit survival to \<2 years or psychiatric conditions which would prevent informed consent or compliance with treatment.
- Presenting with a general or visceral contraindication to intensive treatment including:
- uncontrolled or severe cardiovascular disease, including recent (\<6 months) myocardial infarction or congestive heart failure,
- Current Grade 3 or higher coagulopathy, thrombosis and/or hemostasis disorders,
- Serum creatinine concentration, 1.5 times greater than the upper limit of laboratory normal ranges (ULN), except if related to ALL/LBL,
- total bilirubin 1.5 times greater than the ULN, except if related to ALL/LBL,
- transaminases (AST or ALT) levels, 5 times greater than the ULN, except if related to ALL/LBL,
- An uncontrolled bacterial, viral, or fungal infection or an active duodenal ulcer, until these conditions are corrected or controlled.
- History of Grade 3 or higher allergic reaction with prior asparaginase treatment,
- History of allergy to penicillin or related antibiotic
- History of Grade 3 or higher blood transfusion incident according to US Biovigilance Network which refers to any transfusion followed by a major intervention (vasopressors, intubation, transfer to intensive care) to prevent death.
- Presenting with anti-erythrocyte antibodies leading to the unavailability of phenotype compatible red blood cells.
- Participation in a clinical study involving receipt of an investigational drug during the last 30 days.
- Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.
- Patient receiving treatment likely to cause hemolysis or under phenytoin treatment.
- Patient undergoing yellow fever vaccination.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01910428
Start Date
October 1 2013
End Date
March 1 2018
Last Update
July 5 2018
Active Locations (5)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
University of Maryland, Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
3
Monter Cancer Center
Lake Success, New York, United States, 11042
4
Duke University
Durham, North Carolina, United States, 27705