A Study of RO5072759 (GA101) in Patients With CD20+-Malignant Lymphoma

Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Multi-center, Open Label, Single Arm, Multiple Dose Study to Assess the Pharmacokinetics of RO5072759 in Chinese Patients With CD20+ Malignant Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680991
• Other study ID #: YP25623
• Status: Completed
• Phase: Phase 1
• First received: September 4, 2012
• Last updated: February 1, 2016
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety of RO5072759 (GA101) in patients with CD20+ malignant lymphoma. Patients will receive multiple doses of RO5072759 (GA101). The anticipated time on study treatment is 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >18 years of age

• Diagnosis of CD20+ B-cell lymphoma, chronic lymphocytic lymphoma (CLL), or follicular lymphoma (FL)

• Refractory/relapsed CLL, FL, and diffuse large B cell lymphoma (DLBCL)

• Measurable lesion (>1.5cm in its largest dimension) with the exception of CLL

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Life expectancy over 6 months

Exclusion Criteria:

• Prior use of any investigational antibody therapy within 6 months of study start

• Prior use of any anti-cancer vaccines

• Prior administration of rituximab within 3 months of study start

• Central nervous system lymphoma

• History of other malignancy

• Evidence of significant, uncontrolled concomitant disease

• Abnormal laboratory values

• Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic, Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• RO5072759 [GA101]
multiple doses of RO5072759 [GA101]

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Serum concentration of RO5072759 (GA101)		Predose, Cycle 1, Day 1, 8, 15; Cycles 2-8; Follow up	No
Secondary	Safety: incidence of adverse events		Approximately 2 years	No
Secondary	Treatment response according to criteria for evaluation of response in Non-Hodgkin's-Lymphoma		Approximately 2 years	No
Secondary	Pharmacodynamics: B19+B-cell measurement		Predose, Cycle 1: Day 1, 8; Cycles 2, 4, 6, 8; Follow up	No