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

Lymphoma, Non-Hodgkin's Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00651443
• Other study ID #: 114-NH-103
• Status: Terminated
• Phase: Phase 1
• First received: March 31, 2008
• Last updated: January 6, 2011
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular
• Lymphoma, Non-Hodgkin
• Lymphoma, Non-Hodgkin's

Intervention

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.

Locations

Country	Name	City	State
United States	Research Site	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.		24 months	No
Secondary	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	Yes