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Phase I Study of RO5541077 in Patients with B cell Non-Hodgkin s Lymphoma

Phase I Study of RO5541077 in Patients with B cell Non-Hodgkin s Lymphoma

7

Four patients received RO5541077 1.0 mg/kg and three received 1.8 mg/kg. Four follicular lymphoma patients and three diffuse large B-cell lymphoma patients were enrolled. The median age was 62 years and six patients were female.

The dose escalation followed the standard 3 + 3 design. Three patients were evaluated at the first dose level cohort (1.0 mg/kg), and in the absence of dose-limiting toxicities (DLTs), three additional patients were enrolled at the next dose level cohort (1.8 mg/kg).

The AEs reported in three or more patients were peripheral sensory neuropathy (n = 4), influenza (n = 3), abdominal discomfort (n = 3) and malaise (n = 3); all were grade 1 or 2. Grade 3 AEs were cholecystitis (n = 1), cataract (n = 1), syncope (n = 1) and neutrophil count decreased (n = 1). Neutrophil count decreased was reported to be causally related to RO5541077. No deaths were reported in either cohort.

Both the 1.0 and 1.8 mg/kg doses of RO5541077 were well tolerated and no DLTs were observed.

Based on the best overall response assessed by investigator, four of the seven patients (57%) achieved an objective response, including three CRs and one PR

This study demonstrated that RO5541077 were well tolerated and no DLTs were observed within the dose range of up to 1.8 mg/kg in Japanese patients with B-cell non-Hodgkin lymphoma.

Oct. 08, 2020

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7767980/

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp

completed

July. 14, 2014

Interventional

Open-label, Dose-escalation study

treatment purpose

1

Performance status (PS) of 0 or 1
Relapsed or refractory B cell NHL for which there is no prior standard treatment
Sufficient major organ function

Pregnant or lactating women or women who have tested positive on a pregnancy test
Current or previous history of clinically significant disease
Current or previous history of central nervous system lymphoma
Invasion to the CNS of the primary disease

Both

B cell Non-Hodgkin s Lymphoma

investigational material(s)
Generic name etc : RO5541077
INN of investigational material : polatuzumab vedotin
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : intravenous (IV) administration

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
pharmacokinetics
Assessment and observations

safety
efficacy
Assessment and observation

May. 07, 2014