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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Immunomedics, Inc.
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00504972
First received: July 19, 2007
Last updated: January 3, 2011
Last verified: January 2011
  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 once daily Monday through Friday of each of 2 consecutive weeks (10 total doses.) 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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies

Resource links provided by NLM:


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: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: hLL1
    hLL1 administered intravenously once daily Monday through Friday for 2 consecutive weeks (10 total doses) 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: Gina Mileo, RN 212-746-6738 gjm2003@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 Medical College of Cornell University
  More Information

Additional Information:
No publications provided

Responsible Party: John P. Leonard, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00504972     History of Changes
Other Study ID Numbers: 0608008669
Study First Received: July 19, 2007
Last Updated: January 3, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014