Clinical trial with GRASPA, Red Blood cells encapsulating L-Asparaginase, in patients affected by Acute Lymphoblastic leukemia at relapse

• Conditions: Acute Lymphoblastic Leukaemia; MedDRA version: 15.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2009-012584-34-AT
• Lead Sponsor: ERYTECH Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-31
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

- Patient from 1 to 55 years old
- Children and adolescents from 1 up to 17 years
- Adults over 18 up to 55 years
- Patients with
- Patients with 1st ALL relapse, which could be either isolated bone marrow relapse, or combined (medullary and extra-medullary) relapse, or extra-medullary isolated relapse; or lymphoblastic lymphoma (excepted Burkitt lymphoma)
OR
- Failure to ALL first line treatment (no complete remission obtained).
- Patient previously treated with free E.Coli L-asparaginase form or pegylated one.
- Performance Status = 2 (WHO score).
- Patient informed and consent provided (the 2 parents need to consent when children below 18)
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- ALL t(9;22) and/or BCR-ABL positive (Philadelphia chromosome positive).
- Patient with 2nd relapse and over.
- Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.
- Patient unable to receive treatments used in global chemotherapy protocols, due to general or visceral conditions such as:
- Severe cardiac impairment (NYHA grade 3 or 4 cardiomyopathy)
- Serum creatinine 2 x ULN unless related to ALL
- ALT or AST 5 x ULN unless related to ALL
- Pancreatitis history
- Other malignancy that ALL
- Severe Infection, HIV positive, active hepatitis related to B or C virus infection
- Trisomy 21
- Other serious conditions according to investigator's opinion.
- Known grade 4 allergic reaction to E.Coli L-asparaginase (according NCI-CTCAE, Version 3.0).
- History of grade 3 transfusionnal incident.
- Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient.
- Patient under concomitant treatment likely to cause hemolysis.
- Patient undergoing yellow fever vaccination.
- Patient under phenytoine treatment.
- Patient included in previous clinical study less than 6 weeks

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified