Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody hA20 in Treating Patients With Refractory Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Active	Over 18	Pharmaceutical / Industry	IM-T-HA20-01 NCT00112970

Objectives

Primary

1. Determine the safety and tolerability of monoclonal antibody hA20 in patients with refractory CD20-positive B-cell non-Hodgkin's lymphoma.
2. Determine the immunogenicity of this drug in these patients.

Secondary

1. Determine the pharmacodynamics and pharmacokinetics of this drug in these patients.
2. Determine, preliminarily, the efficacy of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed B-cell non-Hodgkin's lymphoma (NHL)
  • Any grade allowed



• CD20-positive disease



• Measurable disease, defined as ≥ 1 bidimensionally measurable lesion > 1.5 cm by CT scan



• Failed ≥ 1 prior standard chemotherapy regimen OR rituximab therapy for NHL

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• At least 12 months since prior rituximab

Chemotherapy

• See Disease Characteristics
• At least 4 weeks since prior investigational or conventional chemotherapy and recovered

Endocrine therapy

• Not specified

Radiotherapy

• Recovered from prior investigational or conventional radiotherapy
• At least 4 weeks since prior radiotherapy to the index lesion

Surgery

• Recovered from prior investigational or conventional surgery

Patient Characteristics:

Age

• Over 18

Performance status

• ECOG 0-1

  OR

• Karnofsky 80-100%

Life expectancy

• At least 6 months

Hematopoietic

• Hemoglobin > 10 g/dL*
• Absolute neutrophil count > 1,500/mm³*
• Platelet count > 100,000/mm³*

 [Note: *Transfusion independent]

Hepatic

• Bilirubin < 1.5 times upper limit of normal (ULN)
• AST and ALT < 2.5 times ULN

Renal

• Creatinine < 1.5 times ULN

Other

• Not pregnant or nursing
• Negative pregnancy test

Expected Enrollment

Approximately 19-28 patients will be accrued for this study.

Outline

This is a dose-escalation, multicenter study.

Patients receive monoclonal antibody hA20 IV once weekly for 4 weeks.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody hA20. Up to 10 additional patients are then entered at 1 or more dose levels to determine the optimal dose.

After completion of study treatment, patients are followed weekly for 4 weeks, at 8 and 12 weeks, and then every 3 months until disease progression.

Trial Contact Information

Trial Lead Organizations

Immunomedics, Incorporated

William Wegener, MD, PhD, Protocol chair		Ph: 973-605-8200

U.S.A.
New York
	New York
	New York Weill Cornell Cancer Center at Cornell University
		John Leonard, MD	Ph:  973-605-8200 ext. 182
			Email: jpleonar@med.cornell.edu

Registry Information
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
Trial Start Date		2004-02-04
Registered in ClinicalTrials.gov		NCT00112970
Date Submitted to PDQ		2005-03-07
Information Last Verified		2007-05-13