Study of hA20 (Humanized Anti-CD20) in Patients With CD20+ Non-Hodgkin's Lymphoma

Gilead Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: hA20-humanized anti-CD20 antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT00285428

IM-T-hA20-01

Details and patient eligibility

About

This is a Phase I trial to look at safety and how a patient's body will tolerate the treatment at different dosages.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• CD20+ B-cell non-Hodgkin's lymphoma (NHL) with measurable disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 4 patient groups

Dose level 1

Experimental group

Description:

120 mg/m2

Treatment:

Drug: hA20-humanized anti-CD20 antibody

Dose level 2

Experimental group

Description:

200 mg/m2

Treatment:

Drug: hA20-humanized anti-CD20 antibody

Dose Level 3

Experimental group

Description:

375 mg/m2

Treatment:

Drug: hA20-humanized anti-CD20 antibody

Dose level 1B

Experimental group

Description:

80 mg/m2

Treatment:

Drug: hA20-humanized anti-CD20 antibody