Back to resultsMechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin's
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Galiximab
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin's focused on measuring galiximab, Untreated NHL, antibody, open-label
Eligibility Criteria
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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00651443
Brief Title
Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
A company's strategic decision to focus on areas whereit believes it can be competitive and decided to exit Oncology
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin's
Keywords
galiximab, Untreated NHL, antibody, open-label
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Galiximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
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.
Time Frame
48 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma
We'll reach out to this number within 24 hrs