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An Escalating Dose Phase IIa Study of L-Asparaginase Encapsulated in Erythrocytes (GRASPA®) in Association With Polychemotherapy During Induction Phase for Treatment of Elderly Patients With Acute Lymphoblastic Leukaemia (ALL), Aged 55 Years and Over, With Philadelphia Chromosome-negative (ALL Ph-)


Phase 2
55 Years
N/A
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

An Escalating Dose Phase IIa Study of L-Asparaginase Encapsulated in Erythrocytes (GRASPA®) in Association With Polychemotherapy During Induction Phase for Treatment of Elderly Patients With Acute Lymphoblastic Leukaemia (ALL), Aged 55 Years and Over, With Philadelphia Chromosome-negative (ALL Ph-)


Inclusion Criteria:



- Aged ≥ 55 years

- Newly diagnosed ALL without prior treatment

- Patient capable to receive polychemotherapy (WHO < 2)

- With or without meningeal disease

- Signed Informed Consent Forms

- Subscribed to social security insurance

Exclusion Criteria:

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

- General state incompatible with chemotherapy treatment (WHO>2)

- Presenting with a general or visceral contraindication to intensive treatment

- Patient with another cancer other than ALL

- Severe evolutive infection, or, HIV seropositive or, active hepatitis related to B or
C viral infection

- Prior treatment with L-asparaginase (irrespective of the form)

- History of Grade 3 Transfusional incident (life threatening)

- Presenting rare and/or dangerous anti-erythrocyte antibodies thus leading to the
unavailable of a phenotype compatible Red Blood Cells

- Included in another clinical trial during the last 4weeks.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

efficacy and toxicity combined

Outcome Description:

The main evaluation criterion is a composite efficacy/toxicity criterion Efficacy:Percentage of patients responding to treatment i.e. patients with blood levels of plasma asparagine ≤ 2µM over a period of at least 7 days after the administration of GRASPA®. Toxicity:Grade 2,3 or 4 pancreatic toxicity, hepatic toxicity, allergy / Grade 3 or 4 deep cerebral thrombosis / Haematological toxicity /Any other grade 4 toxicity

Outcome Time Frame:

End of induction (2 months)

Safety Issue:

Yes

Authority:

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

Study ID:

GRASPALL/GRAALLSA2-2008

NCT ID:

NCT01523782

Start Date:

April 2009

Completion Date:

October 2012

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Acute Lymphoblastic leukemia
  • Elderly patient
  • Asparaginase
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome

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