Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00651443
Recruitment Status : Terminated (A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology)
First Posted : April 2, 2008
Last Update Posted : January 7, 2011
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Brief Summary:
The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin's Drug: Galiximab Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
Study Start Date : August 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Galiximab
Galiximab 500 mg/m2 IV once weekly times 4, followed by Galiximab 500 mg/m2 IV once monthly times 4 as an extended dosing regimen.

Primary Outcome Measures :
  1. Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. 1) Safety and tolerability of Galiximab when administered as a single agent in an extended dosing regimen in previously untreated subjects with follicular NHL. 2) Evaluation of preliminary clinical activity of galiximab. [ Time Frame: 48 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent (signed and dated).
  • Age equal or greater than 18 at the time of consent.
  • Histologically confirmed follicular NHL according to the Revised European American Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial diagnosis) Grades 1,2, or 3a.
  • At least 2 malignant lymph nodes of similar size (>1 cm in minimal dimension) and location that are readily accessible for excisional biopsy at the time of study entry.
  • Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
  • Acceptable hematologic, hepatic, and renal function parameters.
  • WHO Performance Status equal or less than 2.
  • Subjects of reproductive potential must agree to follow accepted birth control methods.

Exclusion Criteria:

  • Presence of lymphoma in CNS.
  • Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
  • Concurrent treatment with systemic steroids within 14 days of Day 1.
  • Evidence of transformed lymphoma.
  • Presence of malignancies within 3 years of Study Day 1 (except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal or squamous cell skin cancer).
  • History of HIV infection or AIDS.
  • Serious nonmalignant disease.
  • Pregnant.
  • Inability to comply with study and follow-up procedures.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00651443

United States, New York
Research Site
Buffalo, New York, United States, 14263
Sponsors and Collaborators

Responsible Party: Biogen Idec MD, Biogen Idec Identifier: NCT00651443     History of Changes
Other Study ID Numbers: 114-NH-103
First Posted: April 2, 2008    Key Record Dates
Last Update Posted: January 7, 2011
Last Verified: January 2011

Keywords provided by Biogen:
Untreated NHL

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs