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

This study has been terminated.
(A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00651443
First received: March 31, 2008
Last updated: January 6, 2011
Last verified: January 2011
History of Changes
  Purpose

The purpose of the study is to evaluate the mechanism(s) of action of galiximab in subjects with previously untreated follicular NHL.


Condition Intervention Phase
Lymphoma, Non-Hodgkin's
 Drug: Galiximab
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: August 2008
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00651443

Locations
United States, New York
Research Site
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00651443     History of Changes
Other Study ID Numbers: 114-NH-103
Study First Received: March 31, 2008
Last Updated: January 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
galiximab
Untreated NHL
antibody
open-label

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013