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

NCT ID: NCT00651443

Last Updated: 2011-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-12-31

Brief Summary

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

Conditions

Lymphoma, Non-Hodgkin's

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Galiximab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Biogen Idec

Locations

Research Site

Buffalo, New York, United States

Countries

United States

Other Identifiers

114-NH-103

Identifier Type: -

Identifier Source: org_study_id