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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT00504972
Collaborator
Gilead Sciences (Industry)
23
Enrollment
1
Location
1
Arm
100.2
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Trial of Anti-CD74 (hLL1) Antibody Therapy in B Cell Malignancies
Study Start Date :
Jun 1, 2007
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Oct 7, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study Treatment

This study is a single arm study

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.

Outcome Measures

Primary Outcome Measures

  1. 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 [duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Weill Cornell Medical College New York New York United States 10021

Sponsors and Collaborators

  • Weill Medical College of Cornell University
  • Gilead Sciences

Investigators

  • Principal Investigator: John P Leonard, MD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00504972
Other Study ID Numbers:
  • 0608008669
First Posted:
Jul 20, 2007
Last Update Posted:
May 29, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of May 29, 2018