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

Primary Purpose

Non-Hodgkin's Lymphoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

hA20-humanized anti-CD20 antibody

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring treatment, NHL, CD20+ B-cell NHL, Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

New York Presbyterian Hospital/Cornell Medical Center
University Hospital of Pennsylvania
MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Dose level 1

Dose level 2

Dose Level 3

Dose level 1B

Arm Description

120 mg/m2

200 mg/m2

375 mg/m2

80 mg/m2

Outcomes

Primary Outcome Measures

Safety and tolerance of different dose levels

Secondary Outcome Measures

Lack of immunogenicity

Pharmacodynamics

Pharmacokinetics

Efficacy

Full Information

NCT ID

NCT00285428

First Posted

January 31, 2006

Last Updated

August 12, 2021

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00285428

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin's Lymphoma

Keywords

treatment, NHL, CD20+ B-cell NHL, Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose level 1

Arm Type

Experimental

Arm Description

120 mg/m2

Arm Title

Dose level 2

Arm Type

Experimental

Arm Description

200 mg/m2

Arm Title

Dose Level 3

Arm Type

Experimental

Arm Description

375 mg/m2

Arm Title

Dose level 1B

Arm Type

Experimental

Arm Description

80 mg/m2

Intervention Type

Drug

Intervention Name(s)

hA20-humanized anti-CD20 antibody

Other Intervention Name(s)

veltuzumab, IMMU-106, hA20

Intervention Description

once weekly iv dosing for 4 weeks

Primary Outcome Measure Information:

Title

Safety and tolerance of different dose levels

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Lack of immunogenicity

Time Frame

8 and 12 weeks

Title

Pharmacodynamics

Time Frame

over 12 weeks

Title

Pharmacokinetics

Time Frame

over 12 weeks

Title

Efficacy

Time Frame

4, 8 and 12 wks, every 3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Wegener, MD, PhD

Organizational Affiliation

Gilead Sciences

Official's Role

Study Chair

Facility Information:

Facility Name

New York Presbyterian Hospital/Cornell Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

University Hospital of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20214444

Citation

Goldenberg DM, Morschhauser F, Wegener WA. Veltuzumab (humanized anti-CD20 monoclonal antibody): characterization, current clinical results, and future prospects. Leuk Lymphoma. 2010 May;51(5):747-55. doi: 10.3109/10428191003672123.

Results Reference

background

PubMed Identifier

19451441

Citation

Morschhauser F, Leonard JP, Fayad L, Coiffier B, Petillon MO, Coleman M, Schuster SJ, Dyer MJ, Horne H, Teoh N, Wegener WA, Goldenberg DM. Humanized anti-CD20 antibody, veltuzumab, in refractory/recurrent non-Hodgkin's lymphoma: phase I/II results. J Clin Oncol. 2009 Jul 10;27(20):3346-53. doi: 10.1200/JCO.2008.19.9117. Epub 2009 May 18.

Results Reference

result

Learn more about this trial

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

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