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A Dose Escalation Phase I Study of Asparec®(mPEG-R-Crisantaspase) Administered as Intravenous (IV) Infusion in Patients With Relapsed or Refractory Hematological Malignancies


Phase 1
18 Years
50 Years
Open (Enrolling)
Both
Hematologic Malignancies

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Trial Information

A Dose Escalation Phase I Study of Asparec®(mPEG-R-Crisantaspase) Administered as Intravenous (IV) Infusion in Patients With Relapsed or Refractory Hematological Malignancies


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.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Pr Gilles Salles, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Lyon Sud -Chemin du Grand Revoyet

Authority:

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

Study ID:

AZPO2-CLT-001

NCT ID:

NCT01551524

Start Date:

March 2012

Completion Date:

December 2013

Related Keywords:

  • Hematologic Malignancies
  • Leukemia
  • Lymphoma
  • C240588.448
  • C115.378.400
  • Neoplasms
  • Hematologic Neoplasms

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