GP2013 in Japanese Patients With CD20 Positive Low Tumor Burden Indolent B-cell Non-Hodgkin's Lymphoma

Sandoz

Status and phase

Completed

Phase 1

Conditions

Indolent B-cell Non-Hodgkin's Lymphoma

Treatments

Drug: GP2013

Study type

Interventional

Funder types

Industry

Identifiers

NCT01933516

GP13-101

Details and patient eligibility

About

The purpose of this study is to evaluate safety and pharmacokinetic of GP2013 in Japanese patients with CD20 positive low tumor burden indolent B-cell NHL under weekly dosing schedule.

Enrollment

6 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with CD20 positive low tumor burden indolent B-cell non- Hodgkin's lymphoma.
Patient with at least one measurable lesion.
Patient with ECOG performance status 0 or 1.

Exclusion criteria

Patient who has received radiotherapy within the last 28 days prior to administration, or are not recovered from previous radiotherapy.
Patient who has received immunotherapy, chemotherapy, antibodies and experimental treatment within the last 28 days prior to administration, or are not recovered from previous therapy.
Patient who has mAb therapy other than rituximab as prior line of therapy.
Patient with evidence of any uncontrolled, acute or chronic active infection (viral, bacterial or fungal).
Patient with any other malignancy within 5 years prior to date of screening, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or nonmelanomatous skin cancer.

Other protocol-defined inclusion/exclusion criteria may apply.