- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01551524
Phase I Study of mPEG-R-Crisantaspase Given IV
A Dose Escalation Phase I Study of Asparec®(mPEG-R-Crisantaspase) Administered as Intravenous (IV) Infusion in Patients With Relapsed or Refractory Hematological Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Créteil, France, 94010
- Hopital Henri Mondor
-
Nantes, France
- Hôpitaux du CHU de Nantes
-
Pierre-Bénite, France, 69495
- Hospices Civils de Lyon
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Toulouse, France, 31052
- Institut Claudius Regaud
-
-
Cedex
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Rouen, Cedex, France, 76038
- Centre Henri Becquerel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intravenous Erwinia
|
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%
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose
Time Frame: 6 months
|
To determine the Maximum Tolerated Dose following one single dose of mPEG-r-Crisantaspase when administered in a population of patients with relapsed or refractory hematological malignancies, as measured by Dose Limiting Toxicities.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asparaginase Activity in serum
Time Frame: 6 months
|
To determine the pharmacokinetic profile as assessed by measurement of serum L-asparaginase enzymatic activity following single and double mPEG-r-chrisantaspace doses.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pr Gilles Salles, MD, Centre Hospitalier Lyon Sud -Chemin du Grand Revoyet
- Study Director: Xavier Thomas, MD, Centre Hospitalier Lyon Sud - Chemin du Grand Revoyet
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AZPO2-CLT-001
- 2011-000295-34 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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