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

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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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

GP2013
Experimental group
Treatment:
Drug: GP2013

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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