Phase I Study of mPEG-R-Crisantaspase Given IV

NCT ID: NCT01551524

Last Updated: 2015-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-02-28

Brief Summary

This study is an open label, multicenter study with a dose escalation of Asparec® administered once every two to four weeks for two administrations. The primary objective of this study is to determine the Maximum Tolerated Dose following one single dose of Asparec when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting toxicities. There are secondary objectives which are to evaluate the safety of Asparec and to determine the PK profile as assessed by measurement of plasma L-asparaginase enzymatic activity following single and repeated doses of Asparec. Patients response rate will be evaluated and Anti-Asparec antibodies will be measured.

Detailed Description

Planned sample size: Up to 36 evaluable subjects will be enrolled in the study: a maximum of 30 subjects for the dose escalation phase and up to a maximum of 12 patients in the expansion phase.

Inclusion criteria consists of:

Patients with any relapsed or refractory hematological malignancy, for which standard curative or life prolonging treatment does not exist, or is no longer effective or tolerable.

For the following hematological malignancies, patients must have received at least: Low rade NHL: 3 prior lines of therapy, ALL, aggressive NHL and other hematological malignancies: 2 prior lines of therapy, Aged 18 to 50 years and ECOG performance status of 1, 1 or 2.

All patients will be treated with Asparec once every two to four weeks for two IV administrations infused in 60 minutes. Patients without Disease Progression may receive additional administrations, each administration starting at least 14 days but no later than 28 days after the previous Asparec administration.

Conditions

Hematologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intravenous Erwinia

Group Type: EXPERIMENTAL

mPEG-r-crisantaspase

Intervention Type: BIOLOGICAL

IV infusion over 60 minutes of mPEG-r-crisantaspase given once every two or four weeks for two administrations. Based on non-clinical data, 500IU/m2 has been selected as the starting dose. Dose selection will proceed based upon safety and pharmacokinetic data but escalation will not exceed 100%

Interventions

mPEG-r-crisantaspase

IV infusion over 60 minutes of mPEG-r-crisantaspase given once every two or four weeks for two administrations. Based on non-clinical data, 500IU/m2 has been selected as the starting dose. Dose selection will proceed based upon safety and pharmacokinetic data but escalation will not exceed 100%

Intervention Type: BIOLOGICAL

Other Intervention Names

Asparec

Eligibility Criteria

Inclusion Criteria

• Patients with any relapsed or refractory hematological malignancy, for which standard curative or life prolonging treatment does not exist, or is no longer effective or tolerable.
• For the following hematological malignancies, patients must have received at least:

• Low grade NHL:

• 3 prior lines of therapy and ALL,
• aggressive NHL and other hematological malignancies:

• 2 prior lines of therapy.
• Ages 18 to 50 years and
• ECOG performance status of 0, 1 or 2,
• ability to understand and to sign a written informed consent and
• have a life expectancy of greater than or equal to 90 days

Exclusion Criteria

• Any active CNS disease,
• previous greater than or equal to grade 3 allergic reaction to Erwinase,
• patients who have experienced a greater than or equal to grade 3 allergic reaction to E. coli L-asparaginase and who have never received E. chrysanthemi L-asparaginase after the occurrence of this reaction,
• WBC count greater than 20 Gica/L, any of the following laboratory abnormalities if not due to hematologic malignancy (calculated creatinine clearance less than 50 mL/min,
• serum SGOT/AST or SGPT?ALT greater than 2.5 x upper limit of normal,
• serum total bilirubin greater than 2.0 mg/dL, except in the case of hemolytic anemia.
• Patients cannot have a history of greater than or equal to grade 2 pancreatitis,
• any history of allogeneic transplant,
• receiving steroid therapy with a dose greater than 20 mg/day,
• known HIV positive serology,
• active hepatitis B or C,
• any serious active disease or comorbid medical condition or psychiatric illness that would prevent the subject from signing the informed consent.
• Pregnant or lactating females or women of child bearing potential not willing to use an adequate method of birth control for the duration of the study are not eligible.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EUSA SAS

UNKNOWN

Sponsor Role: collaborator

The Lymphoma Academic Research Organisation

OTHER

Sponsor Role: collaborator

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pr Gilles Salles, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Lyon Sud -Chemin du Grand Revoyet

Xavier Thomas, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Lyon Sud - Chemin du Grand Revoyet

Locations

Centre Henri Becquerel

Rouen, Cedex, France

Hôpital Henri Mondor

Créteil, , France

Hôpitaux du CHU de Nantes

Nantes, , France

Hospices Civils de Lyon

Pierre-Bénite, , France

Institut Claudius Regaud

Toulouse, , France

Countries

France

Other Identifiers

2011-000295-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AZPO2-CLT-001

Identifier Type: -

Identifier Source: org_study_id