NCT04067518

A Clinical Study of SHP674 (Pegaspargase) in Participants With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

A Phase 2 Clinical Study of SHP674 in Patients With Newly Diagnosed, Untreated Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Institut de Recherches Internationales Servier · Academic / Other
• Sex: All
• Age: 1 Year – 21 Years
• Healthy volunteers: Not accepted

Summary

The objectives of the study are to assess the safety and tolerability of a single dose of SHP674 in Japanese participants (dose confirmation) in the tolerability assessment period of Part 1 and to assess the safety, pharmacokinetics and efficacy of SHP674 dose in Part 2 (found to be tolerated in Part 1) in the treatment of newly diagnosed untreated acute lymphoblastic leukemia (ALL) in Japanese participants.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	SHP674	SHP674: powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m\^2: 2500 IU/m\^2 every 14 days if BSA \<0.6 m\^2: 82.5 IU/kg every 14 days

Timeline

• Start date: 2019-10-17
• Primary completion: 2021-02-12
• Completion: 2022-02-04
• First posted: 2019-08-26
• Last updated: 2023-04-20
• Results posted: 2022-06-10

Locations

8 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study