Clinical trials: Leucogen
Acute Lymphoblastic Leukemia
Expanded Access Program: Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.
- Trial name
- EAP (NCT02197650)
- Testing
- suspension of erythrocytes encapsulating L-asparaginase
- Where
- 10 sites in France
- Sponsor
- ERYtech Pharma
Acute Lymphoblastic Leukemia
Comparative Efficacy and Safety of Two Asparaginase Preparations in Children With Previously Untreated Acute Lymphoblastic Leukaemia
This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL
- Trial name
- NCT00784017
- Testing
- asparaginase, recombinant asparaginase
- Where
- Netherlands
- Volunteers
- 199 people
- Sponsor
- medac GmbH
Acute Lymphoblastic Leukemia, in Relapse
GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodies (A-Abs), which can also…
- Trial name
- GRASPIVOTALL (NCT01518517)
- Testing
- GRASPA, L-asparaginase
- Where
- 28 sites in Belgium, France
- Volunteers
- 85 people
- Sponsor
- ERYtech Pharma
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy.
- Trial name
- NCT01643408
- Testing
- asparaginase Erwinia chrysanthemi
- Where
- 22 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Jazz Pharmaceuticals
Lymphoma, Acute Lymphoblastic Leukemia
A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma.
- Trial name
- NCT02369653
- Testing
- Apixaban, No systemic anticoagulant prophylaxis
- Where
- 96 sites in United States, Australia and 10 more
- Volunteers
- 512 people
- Sponsor
- Bristol-Myers Squibb
Acute Lymphoblastic Leukemia
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Primary objective : To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (< 2µmol/l) Secondary objective : Pharmacokinetic / Pharmacodynamic parameters toxicity Study duration : 2 years Study…
- Trial name
- GRASPALL (NCT00723346)
- Testing
- GRASPA, native L asparaginase
- Where
- France
- Volunteers
- 25 people
- Sponsor
- ERYtech Pharma
Acute Lymphoid Leukemia
Efficacy and Safety of Recombinant Asparaginase in Infants With Previously Untreated Acute Lymphoid Leukemia (ALL)
This non-controlled multicentre phase II study is designed to assess the safety and to describe (in relation to children of higher age) the pharmacodynamics of recombinant ASNase (rASNase) for first-line treatment of infants (< 1…
- Trial name
- NCT00983138
- Testing
- recombinant asparaginase
- Where
- 17 sites in Germany, Netherlands
- Volunteers
- 12 people
- Sponsor
- medac GmbH
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
JZP458 - Recombinant Erwinia Asparaginase for Treatment of ALL / LBL Patients With Hypersensitivity to E. Coli-derived Asparaginase
This study is an Expanded Access Protocol (EAP) of JZP458 in participants with ALL/LBL who are hypersensitive to an E.coli-derived asparaginase (allergic reaction or silent inactivation) and unable to access alternative licensed…
- Trial name
- NCT04943952
- Testing
- Asparaginase Erwinia Chrysanthemi (recombinant)
- Sponsor
- Jazz Pharmaceuticals
Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation).
- Trial name
- NCT04145531
- Testing
- IM JZP-458, IV JZP-458
- Where
- 74 sites in United States, Canada
- Volunteers
- 229 people
- Sponsor
- Jazz Pharmaceuticals
Lymphoblastic Leukemia, Acute, Childhood
A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)
This is an open-label study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine to assess this 5-drug treatment's safety and tolerability in pediatric patients with first relapse Acute Lymphoblastic…
- Trial name
- NCT00991133
- Testing
- Clofarabine incorporated into a 5-drug regimen
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Genzyme, a Sanofi Company