PH 2 ADI-PEG 20 Study in Non-Hodgkin's Lymphoma Subjects Who Have Failed Prior Systemic Therapy

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma
• Interventions: Drug: ADI-PEG 20

• Registration Number: NCT01910025
• Lead Sponsor: Polaris Group

Brief Summary

Certain cancers require the amino acid arginine. Arginine deiminase (ADI) is an enzyme from microbes that degrade arginine. ADI has been formulated with polyethylene glycol and has been used to treat patients that have cancers that have arginine. In this study, the primary efficacy variable will be assessment of tumor response rate.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-29
• Study Start: 2013-12-06
• Status Verified: 2016-04
• Primary Completion: 2016-08-31
• Study Completion: 2017-12-15
• Disposition First Submitted: 2018-08-30
• Disposition First Submitted QC: 2018-08-30
• Disposition First Posted: 2018-09-04
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADI-PEG 20	ADI-PEG 20	arginine deiminase formulated with polyethlene glycol

Primary Outcome Measures

Name	Time	Method
Response Rate	2 years estimated	Determined by response criteria for cutaneous and non-cutaneous malignant lymphoma

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability	2 years estimated	Progression free survival - time from start of therapy until proven progression or death Overall survival Time on treatment Disease control rate Determine the pharmacodynamics of ADI-PEG 20 Determine the immunogenicity of ADI-PEG 20

Trial Locations

Locations (5)

Chang Gung Medical Foundation-Kaohsiung; 🇨🇳 Kaohsiung City, Taiwan

National Cheng Kung University Hospital(NCKUH); 🇨🇳 Tainan City, Taiwan

CMUH; 🇨🇳 Taichung, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung City, Taiwan

CGMH-LK; 🇨🇳 Taoyuan, Taiwan