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

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

Official Title
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A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma

Conditions
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Lymphoma, Non-Hodgkin's

Intervention / Treatment
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* Drug: Galiximab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Galiximab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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galiximab, Untreated NHL, antibody, open-label