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

Sponsor

Gilead Sciences (Industry)

Overall Status

Completed

CT.gov ID

NCT00285428

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

27.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Non-Hodgkin's Lymphoma	Drug: hA20-humanized anti-CD20 antibody	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I Study of Immunotherapy With hA20 Administered Once Weekly for 4 Consecutive Weeks in Patients With CD20+ Non-Hodgkin's Lymphoma

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose level 1 120 mg/m2	Drug: hA20-humanized anti-CD20 antibody once weekly iv dosing for 4 weeks Other Names: veltuzumab IMMU-106 hA20
Experimental: Dose level 2 200 mg/m2	Drug: hA20-humanized anti-CD20 antibody once weekly iv dosing for 4 weeks Other Names: veltuzumab IMMU-106 hA20
Experimental: Dose Level 3 375 mg/m2	Drug: hA20-humanized anti-CD20 antibody once weekly iv dosing for 4 weeks Other Names: veltuzumab IMMU-106 hA20
Experimental: Dose level 1B 80 mg/m2	Drug: hA20-humanized anti-CD20 antibody once weekly iv dosing for 4 weeks Other Names: veltuzumab IMMU-106 hA20

Outcome Measures

Primary Outcome Measures

Safety and tolerance of different dose levels [12 weeks]

Secondary Outcome Measures

Lack of immunogenicity [8 and 12 weeks]
Pharmacodynamics [over 12 weeks]
Pharmacokinetics [over 12 weeks]
Efficacy [4, 8 and 12 wks, every 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York Presbyterian Hospital/Cornell Medical Center	New York	New York	United States	10021
2	University Hospital of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
3	MD Anderson Cancer Center	Houston	Texas	United States	77030