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

Phase 1

Terminated

• Conditions: Lymphoma, Non-Hodgkin's
• Interventions: Drug: Galiximab

• Registration Number: NCT00651443
• Lead Sponsor: Biogen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-02
• Study Start: 2008-08
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-06
• Last Update Posted: 2011-01-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Galiximab	-

Primary Outcome Measures

Name	Time	Method
Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.	24 months

Secondary Outcome Measures

Name	Time	Method
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.	48 months

Trial Locations

Locations (1)

Research Site; 🇺🇸 Buffalo, New York, United States