SPARK-ALL: Calaspargase Pegol in Adults With ALL

Purpose

The purpose of this phase 2/3 study is to confirm the recommended doses and to evaluate the safety and pharmacodynamics of Calaspargase pegol for the treatment of adult patients with Philadelphia-negative Acute Lymphoblastic Leukemia.

Condition

  • Acute Lymphoblastic Leukemia

Eligibility

Eligible Ages
Between 22 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged ≥22 and <55 years with newly-diagnosed and cytologically confirmed and documented Philadelphia-negative B-cell or T-cell ALL by World Health Organization (WHO) classification (2016). - Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. - No prior therapy for ALL such as chemotherapy and radiation therapy before signing the informed consent except for limited treatment (≤7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.

Exclusion Criteria

  • Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, and acute undifferentiated leukemia per WHO classification (2016). - Patients with Down syndrome. - Patients with Hepatitis B (positive for HBs antigen), and Hepatitis C (HCV antibody) at inclusion - Participants known to be HIV-positive. - Known history of non-gallstone-related pancreatitis. - Known severe hepatic impairment (bilirubin >3 x upper limit of normal [ULN]; transaminases >10 times ULN. - Pre-existing history of hepatic veno-occlusive disease (VOD). - Age ≥ 55 years. - BMI > 35 kg/m2.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Calaspargase pegol (S95015)
  • Drug: Calaspargase pegol (S95015)
    Part 1: S95015 will be administered at dose of 2000 U/m2, 1500 U/m2 or 1000 U/m2 (dose level based on age and BMI) via a 2-hour intravenous infusion at Day 4 (or 5, or 6) of the induction phase, Days 15 and 43 of the consolidation phase, Day 22 of the interim maintenance phase and Days 4 (or 5, or 6) and 43 of the delayed intensification phase. S95015 starting doses for age and BMI groups will be confirmed. Patients will receive premedication prior to calaspargase pegol administration (acetaminophen, histamine-1 blocker, and corticosteroids to prevent hypersensitivity reaction) and other backbone chemotherapy agents based on the CALGB 10403 protocol treatment regimen. Part 2: Patients aged 22 to 39 years + BMI ≤ 35 kg/m2 will be treated with S95015 1750 U/m2. Patients aged 40 to < 55 years + BMI ≤ 35 kg/m2 will be treated with S95015 1500 U/m2, unchanged from Part 1. Patients 55 years or older or those with a BMI greater than 35 kg/m2 will no longer be enrolled into Part 2.

Recruiting Locations

University of Kansas Cancer Center - Richard and Annette Bloch Cancer Care Pavilion
Westwood, Kansas 66205

More Details

Status
Recruiting
Sponsor
Institut de Recherches Internationales Servier

Study Contact

Institut de Recherches Internationales Servier, Clinical Studies Department
+33 1 55 72 43 66
scientificinformation@servier.com

Detailed Description

The study will be conducted in 2 parts. Part 1 is a dose confirmation run-in period. Part 2 will enroll the remaining participants at the dose as confirmed in Part 1.