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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01680991
First received: September 4, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Lymphocytic Leukemia, Chronic, Lymphoma, B-Cell, Non-Hodgkin's Lymphoma
Drug: RO5072759 [GA101]
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Serum concentration of RO5072759 (GA101) [ Time Frame: Predose, Cycle 1, Day 1, 8, 15; Cycles 2-8; Follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: incidence of adverse events [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Treatment response according to criteria for evaluation of response in Non-Hodgkin's-Lymphoma [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Pharmacodynamics: B19+B-cell measurement [ Time Frame: Predose, Cycle 1: Day 1, 8; Cycles 2, 4, 6, 8; Follow up ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO5072759 [GA101] Drug: RO5072759 [GA101]
multiple doses of RO5072759 [GA101]

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680991

Locations
China
Beijing, China, 100021
Beijing, China, 100036
Guangzhou, China, 510080
Shanghai, China, 200025
Tianjin, China, 300020
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01680991     History of Changes
Other Study ID Numbers: YP25623
Study First Received: September 4, 2012
Last Updated: April 7, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014