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

NCT00651443 | Terminated Phase 1

• 1 other identifier: 114-NH-103
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

galiximab; Untreated NHL; antibody; open-label

Outcome Measures

Primary Outcomes (1)

• Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.

  24 months

Secondary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: Galiximab

Interventions

Galiximab 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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

galiximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: August 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 7, 2011

Record last verified: 2011-01

Locations

US (1)