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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, B-Cell, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pharmacokinetics: Serum concentration of RO5072759 (GA101)

Outcome Time Frame:

Predose, Cycle 1, Day 1, 8, 15; Cycles 2-8; Follow up

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

China: Food and Drug Administration

Study ID:

YP25623

NCT ID:

NCT01680991

Start Date:

September 2012

Completion Date:

December 2014

Related Keywords:

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

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