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Administration of GRASPA (Suspension of Erythrocytes Encapsulating L-asparaginase) in Elderly Patients With First Line Acute Lymphoblastic Leukemia

Information source: ERYtech Pharma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia

Intervention: GRASPA (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: ERYtech Pharma

Summary

There is not clinical validation that the benefits of L-asparaginase can offers during induction chemotherapy for elderly patients, where prevent toxicities is critical. This Phase IIa clinical trial propose to evaluate, specifically for elderly patients, the tolerated dose of GRASPA® in combination with a poly chemotherapy treatment which enables efficient L-asparagine depletion for a period at least equal to 7 days.

Clinical Details

Official title: 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-)

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

Primary outcome: efficacy and toxicity combined

Secondary outcome:

Serum concentrations of asparagine,aspartate,glutamine, glutamate and asparaginase.

Immunogenicity: evaluation of the titer of the anti-asparaginase antibody

Percentage of haematological Complete Remission after each induction phase

Cerebral Spinal Fluid concentrations of asparagine,aspartate,glutamine, glutamate

Overall Survival

Event Free Survival

Disease Free Survival

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: March 7, 2013

Page last updated: August 20, 2015

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