Clinical trials: Leucogen
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
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, 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
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia
The main purpose of this study is to determine the maximum tolerated and efficient dose of GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years and over, Philadelphia chromosome-negative…
- Trial name
- NCT01523782
- Testing
- GRASPA
- Volunteers
- 30 people
- Sponsor
- ERYtech Pharma
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
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
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
L-asparaginase Encapsulated in Red Blood Cells (Eryaspase) for Treatment of Adult Patients With ALL or LBL
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.
- Trial name
- NCT01910428
- Testing
- L-asparaginase encapsulated in RBC
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- ERYtech Pharma
Acute Lymphoblastic Leukaemia
Trial of Oncaspar® and Three Doses of Pegylated Recombinant Asparaginase in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukaemia
This is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (PEG-rASNase) in comparison to Oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (ALL).
- Trial name
- NCT01251809
- Testing
- Oncaspar, PEG-rASNase
- Where
- 30 sites in Germany
- Volunteers
- 56 people
- Sponsor
- medac GmbH
Pancreatic Adenocarcinoma
Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC
This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have…
- Trial name
- Trybeca-1 (NCT03665441)
- Testing
- eryaspase, Gemcitabine plus Abraxane, Irinotecan plus 5-FU plus leucovorin
- Where
- 16 sites in United States, France and 1 more
- Volunteers
- 512 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
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
Pancreatic Cancer
Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase)in Patients With Pancreatic Cancer
The interest in using L-asparaginase in pancreatic cancer arose from in vitro and in vivo studies data showing an anti-neoplastic effect on pancreatic tumor cell lines.
- Trial name
- NCT01523808
- Testing
- GRASPA
- Volunteers
- 12 people
- Sponsor
- ERYtech Pharma
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, 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
Acute B-Cell Lymphoblastic Leukaemia
PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia
This is a non-controlled, single-arm, open-label clinical trial to describe the PK, PD, immunogenicity and safety of ASNase. All subjects enrolled will receive the IP recombinant ASNase (Spectrila®).
- Trial name
- NCT03156790
- Testing
- Spectrila®
- Where
- 8 sites in Brazil
- Volunteers
- 40 people
- Sponsor
- medac GmbH
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 Myeloid Leukemia
GRASPA Treatment for Patients With Acute Myeloblastic Leukemia
The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65 years diagnosed with AML and unfit for intensive…
- Trial name
- ENFORCE (NCT01810705)
- Testing
- GRASPA
- Where
- 21 sites in France
- Volunteers
- 123 people
- Sponsor
- ERYtech Pharma
Pancreatic Adenocarcinoma Metastatic
Efficacy and Safety of L-asparaginase Encapsulated in RBC Combined With Gemcitabine or FOLFOX in 2nd Line for Progressive Metastatic Pancreatic Carcinoma
A new approach that aims to destroy pancreatic tumor cells through modification of the tumor environment. Asparagine synthetase (ASNS) is an enzyme wich synthetise asparagine.
- Trial name
- NCT02195180
- Testing
- ERY001, Gemcitabine, 5-fluoro-uracil/oxaliplatin/leucovorin (folfox)
- Where
- 16 sites in France
- Volunteers
- 141 people
- Sponsor
- ERYtech Pharma
Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)
The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase.
- Trial name
- NCT02150928
- Testing
- Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)
- Where
- Spain
- Sponsor
- Jazz Pharmaceuticals