Phase I Study of mPEG-R-Crisantaspase Given IV

NCT01551524 | Completed Phase 1

• 2 other identifiers: AZPO2-CLT-0012011-000295-34
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 5

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.

Conditions

Hematologic Malignancies

Keywords

Leukemia; Lymphoma; C240588.448; C115.378.400

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose

  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 Outcomes (1)

• Asparaginase Activity in serum

  6 months

Study Arms (1)

Intravenous Erwinia

EXPERIMENTAL

Biological: mPEG-r-crisantaspase

Interventions

mPEG-r-crisantaspase 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%

Also known as: Asparec

Intravenous Erwinia

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• EUSA SAS: collaborator
• The Lymphoma Academic Research Organisation: collaborator

Study Sites (5)

Centre Henri Becquerel

Rouen, Cedex, 76038, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpitaux du CHU de Nantes

Nantes, France

Location

Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Pr Gilles Salles, MD

  Centre Hospitalier Lyon Sud -Chemin du Grand Revoyet

  PRINCIPAL INVESTIGATOR

• Xavier Thomas, MD

  Centre Hospitalier Lyon Sud - Chemin du Grand Revoyet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 12, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 7, 2015

Record last verified: 2015-02

Locations

FR (5)