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

NCT ID: NCT00285428

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-10-31

Brief Summary

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

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose level 1

120 mg/m2

Group Type EXPERIMENTAL

hA20-humanized anti-CD20 antibody

Intervention Type DRUG

once weekly iv dosing for 4 weeks

Dose level 2

200 mg/m2

Group Type EXPERIMENTAL

hA20-humanized anti-CD20 antibody

Intervention Type DRUG

once weekly iv dosing for 4 weeks

Dose Level 3

375 mg/m2

Group Type EXPERIMENTAL

hA20-humanized anti-CD20 antibody

Intervention Type DRUG

once weekly iv dosing for 4 weeks

Dose level 1B

80 mg/m2

Group Type EXPERIMENTAL

hA20-humanized anti-CD20 antibody

Intervention Type DRUG

once weekly iv dosing for 4 weeks

Interventions

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hA20-humanized anti-CD20 antibody

once weekly iv dosing for 4 weeks

Intervention Type DRUG

Other Intervention Names

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veltuzumab IMMU-106 hA20

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Immunomedics, Inc.

Principal Investigators

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William Wegener, MD, PhD

Role: STUDY_CHAIR

Gilead Sciences

Locations

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New York Presbyterian Hospital/Cornell Medical Center

New York, New York, United States

Site Status

University Hospital of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20214444 (View on PubMed)

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.

Reference Type RESULT
PMID: 19451441 (View on PubMed)

Other Identifiers

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IM-T-hA20-01

Identifier Type: -

Identifier Source: org_study_id

NCT00112970

Identifier Type: -

Identifier Source: nct_alias

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