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Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia


Phase 2/Phase 3
1 Year
55 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia, in Relapse

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Trial Information

Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia


Inclusion Criteria:



- Patient from 1 to 55 years old (Children and adolescents from 1 to 17 years/ Adults
from 18 to 55 years)

- Patients with 1st ALL relapse, which could be either isolated bone marrow relapse, or
combined (medullary and extra-medullary) relapse, or extra-medullary isolated CNS
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
are below 18)

Exclusion Criteria:

- ALL t(9;22) and/or BCR-ABL positive (Philadelphia chromosome positive)

- Patient with 2nd relapse and over

- Isolated extra-medullary relapse, excluding isolated CNS relapse

- 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 transfusional 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 phenytoin treatment

- Patient included in previous clinical study less than 6 weeks ago

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy and toxicity combined

Outcome Description:

efficacy assessed according mean duration of asparaginase depletion / toxicity assessed according incidence of allergic reaction whatever the grade

Outcome Time Frame:

1 month

Safety Issue:

Yes

Principal Investigator

Yves Bertand, MD

Investigator Role:

Principal Investigator

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GRASPALL2009-06

NCT ID:

NCT01518517

Start Date:

December 2009

Completion Date:

March 2014

Related Keywords:

  • Acute Lymphoblastic Leukemia, in Relapse
  • acute lymphoblastic leukemia
  • relapse
  • asparaginase
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Recurrence

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