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

Sponsor

Biogen (Industry)

Overall Status

Terminated

CT.gov ID

NCT00651443

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

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 :

Aug 1, 2008

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL. [24 months]

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. [48 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.