Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies - Full Text View

Sponsors and Collaborators:	Weill Medical College of Cornell University Immunomedics, Inc.
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00504972

Purpose

Previous experience with antibody therapy in both NHL and CLL warrants further exploration of new antibody treatments for these diseases.

Immunomedics has developed hLL1 (previously designated EPB-1), which is a CDR-grafted, fully humanized monoclonal antibody specifically targeting CD74.38 The human IgG1 backbone for hLL1 is the same as hLL2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated in clinical trials of patients with B-cell malignancies and autoimmune disorders.

This is a Phase I, open-label, study conducted in patients with recurrent non-Hodgkin's lymphoma (NHL) or chronic lymphocytic leukemia (CLL) who have progressed after at least one prior standard treatment. All patients will receive hLL1 administered intravenously day 1 and day 4 of each week for 6 consecutive weeks. Patients will be assigned to a cohort for hLL1 treatment dose assignment (escalating doses of hLL1 per statistical plan) in order to determine the maximum tolerated dose (MTD) for this administration schedule.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma Chronic Lymphocytic Leukemia	Drug: hLL1	Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

To determine the toxicity profile and maximum tolerated dose (MTD) of hLL1 when administered to patients with recurrent non-Hodgkin's lymphoma and chronic lymphocytic leukemia [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

hLL1 administered intravenously twice weekly(Days 1 and 4)for 6 consecutive weeks at one of 4 planned dose levels: 1.5, 4, 6 or 8 mg/kg.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of recurrent B cell non-Hodgkin's lymphoma or diagnosis of recurrent chronic lymphocytic leukemia
Patient has received at least one prior treatment with standard chemotherapy and at least one prior treatment with rituximab (negative HAHA test required if received prior humanized antibody treatment)
Patient has not received anti-cancer therapy within 28 days of treatment unless disease progression has been demonstrated and toxicities from prior therapy have resolved
Available tumor tissue (lymph node/mass, blood or bone marrow) for correlative analyses (paraffin or frozen, recent or archived)
Measurable disease as defined by a tumor mass > 1.5 cm in one dimension or WBC > 5,000 (CLL patients)
Age > 18 years
Patient has KPS > 50%
Absolute granulocyte count > 1000 cells/mm3
Platelet count > 50,000 cells/mm3
Creatinine < 2.0 x ULN
Total bilirubin < 2.0 x ULN
Patient agrees to use birth control if of reproductive potential
Patient has signed IRB-approved informed consent

Exclusion Criteria:

Known central nervous system (CNS) involvement by lymphoma
Known HIV disease
Patient is pregnant or nursing
Patient is receiving other investigational drugs
Known serum human anti-human antibodies (HAHA)
Estimated life expectancy of < 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504972

Contacts

Contact: Trish Glynn, RN	212-746-6738	pwg2002@med.cornell.edu
Contact: Peter Martin, MD		pem9019@med.cornell.edu

Locations

United States, New York
Weill Cornell Medical College	Recruiting
New York, New York, United States, 10021
Contact: Trish Glynn, RN 212-746-6738 pwg2002@med.cornell.edu
Sub-Investigator: Peter Martin, MD
Sub-Investigator: Stanley Goldsmith, MD
Sub-Investigator: Shankar Vallabhajosula, PhD
Sub-Investigator: Richard Furman, MD
Sub-Investigator: Jia Ruan, MD, PhD
Principal Investigator: John P Leonard, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

Immunomedics, Inc.

Investigators

Principal Investigator:

John P Leonard, MD

Weill Cornell Medical College

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Weill Cornell Medical College ( John P. Leonard, MD )
Study ID Numbers:	0608008669
Study First Received:	July 19, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00504972
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Chronic lymphocytic leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoma, small cleaved-cell, diffuse
Leukemia
Lymphatic Diseases

Antibodies
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009