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Study of MDX-1342 in Patients With Chronic Lymphocytic Leukemia (CLL)
This study is currently recruiting participants.
Verified by Medarex, January 2008
Sponsored by: Medarex
Information provided by: Medarex
ClinicalTrials.gov Identifier: NCT00593944
  Purpose

The purpose of this study is to see at what dose MDX-1342, a monoclonal antibody, is safe and tolerable for patients with chronic lymphocytic leukemia (CLL). Information on any responses that patients may have to the drug will also be collected.


Condition Intervention Phase
Chronic Lymphocytic Leukemia
Biological: MDX-1342
Phase I

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic
Drug Information available for: Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase 1, Open-Label, Multiple-Dose, Dose-Escalation Study of MDX-1342 in Patients With CD19-Positive Refractory/Relapsed Chronic Lymphocytic Leukemia

Further study details as provided by Medarex:

Primary Outcome Measures:
  • incidence and severity of treatment-emergent adverse events [ Time Frame: all events will be followed to resolution ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • vital sign measurements [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
  • clinical laboratory tests [ Time Frame: study duratation - each visit ] [ Designated as safety issue: No ]
  • immunogenicity evaluations [ Time Frame: first and last dose of drug and during follow up ] [ Designated as safety issue: No ]
  • ECOG evaluation [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
  • physical examination [ Time Frame: study duration - each visit ] [ Designated as safety issue: No ]
  • electrocardiogram [ Time Frame: at screening and study completion ] [ Designated as safety issue: No ]
  • diagnostic testing [ Time Frame: at screening and study completion ] [ Designated as safety issue: No ]
  • pharmacokinetics sampling [ Time Frame: at each dosing visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: February 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Patients will receive active MDX-1342.
Biological: MDX-1342
MDX-1342 is given as a 90 minute i.v. infusion. Patients will receive one of the following dose levels, 0.7, 7, 21, 70, 210, 700 or 2100 mg/dose.

Detailed Description:

Chronic lymphocytic leukemia (CLL) is a monoclonal hematopoietic disorder characterized by a progressive expansions of lymphocytes of B-cell lineage. These small, mature-appearing lymphocytes accumulate in the blood, bone marrow, lymph nodes, and spleen. CLL is a common leukemia in the wester world and accounts for 25% to 30% of adult leukemias. CD19,an integral membrane protein, is expressed by pro-B cells and functions as a co-stimulatory molecule that regulates mature B-cell activation and enhances B-cell proliferation. MDX-1342, a fully human monoclonal antibody, has demonstrated to specifically bind to human CD19 antigen with high affinity. Therefore, it is theorized that MDX-1342 will block activation of B cell stimulation, decreasing the number of cancerous B cell clones.

  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 CD19-positive CLL with evidence of relapse/refractory disease.
  • At least 28 days since the last chemotherapy or radiation prior to the first dosing of MDX-1342 and have recovered from any toxicity associated with such treatment or returned baseline.
  • At least 28 days prior to the first dose of MDX-1342 since any major surgery.
  • At least 18 years of age.
  • At least 12 weeks life expectancy.
  • ECOG Performance Status 0 to 2.
  • Screening laboratory values must be met.
  • Women must meet 1 of the following criteria: post-menopausal for at least 2 years; surgically incapable of bearing children or utilizing a reliable form of contraception.
  • Med on corticosteroids must be tapered off the medication 14 days prior to the first dose of MDX-1342 and must remain off all corticosteroids during the Initial Treatment Phase and all Re-treatment Phases (except as indicated for Grade 3 infusion reactions). Corticosteroid use will be allowed during all Follow-up Phases.

Exclusion Criteria:

  • Previous treatment with any other anti-CD19 antibody.
  • Any other active malignancy within 2 years prior to enrollment excluding basal or squamous cell carcinoma of the skin or cervical carcinoma in situ.
  • Any active, uncontrolled infection.
  • Prior allogeneic bone marrow transplant.
  • Active autoimmune disease requiring immunosuppressive therapy.
  • Known current drug or alcohol abuse.
  • Apparent active or latent tuberculosis (TB) infection (purified protein derivative (PPD) test is not required) as indicated by any of the following: PPD recently converted to positive, chest x-ray with evidence of infection, recent changes in fever/chill patterns.
  • Patients who are pregnant or nursing.
  • Any underlying medical condition which, in the Principal Investigator's opinion, will make the administration of MDX-1342 hazardous or obscure the interpretation of adverse events.
  • Patients on concomitant chemotherapy, corticosteroids, investigational agents, growth factors cytokines, radiation therapy, or growth factors (GM-CSF or G-CSF may be used to treat neutropenia, however prophylactic use is prohibited). Hormonal therapy and biologic therapy for the treatment of CLL or other cancers is also prohibited.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593944

Contacts
Contact: David Eardley 1-908-479-2630 deardley@medarex.com

Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Medarex
Investigators
Principal Investigator: Asher Chanan-Khan, MD Roswell Park Cancer Institute
Principal Investigator: Jennifer Brown, MD, PhD Dana-Farber Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute ( Asher Chanan-Khan )
Study ID Numbers: MDX1342-02
Study First Received: January 3, 2008
Last Updated: September 11, 2008
ClinicalTrials.gov Identifier: NCT00593944  
Health Authority: United States: Food and Drug Administration

Keywords provided by Medarex:
CLL
Chronic Lymphocytic Leukemia
B cell
leukemia
lymphocyte
antibody
monoclonal
cancer
blood

Study placed in the following topic categories:
Chronic lymphocytic leukemia
Lymphatic Diseases
Leukemia
Antibodies
Leukemia, Lymphoid
Immunoproliferative Disorders
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-cell, chronic
Lymphoproliferative Disorders
Leukemia, B-Cell
Immunoglobulins

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009