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: August 26, 2014
Last verified: August 2014
  Purpose

This multi-center, open-label, single-arm study will evaluate the pharmacokineti cs and safety of RO5072759 (GA101) in patients with CD20+ malignant lymphoma. Pa tients 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
China
Beijing, China, 100021
Beijing, China, 100142
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: August 26, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Leukemia, Lymphoid
Lymphoma, B-Cell
Lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Leukemia, B-Cell
Obinutuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014