Non-Hodgkin’s Lymphoma Studies
   
  114-NH-103
Follicular Non Hodgkins Lymphoma
 
 
   
 
 
 
 
 
 
 
 
 
 

 


114-NH-103

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

This study is currently recruiting participants.

Purpose

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


Study Design:  Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
 
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


Further study details as provided by Biogen Idec:

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. 
Estimated Enrollment:   20
Study Start Date:   August 2008
Estimated Study Completion Date:   May 2012
Estimated Primary Completion Date:  

May 2011 (Final data collection date for primary outcome measure)

 

Arms Assigned Interventions
1: Experimental
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.


Eligibility

Ages Eligible for Study:  

18 Years and older

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  1. Written informed consent (signed and dated).
  2. Age equal or greater than 18 at the time of consent.
  3. 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.
  4. Malignant lymph node(s) or lymph node mass that is readily accessible for incisional/excisional biopsy at study entry and satisfies one of the following:
    a. At least 2 lymph nodes of similar size (>1 cm in minimal dimension) and location
    OR
    b. A single lymph node or a confluent lymph node mass of sufficient size to support 2 independent incisional/excisional biopsy procedures
  5. Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.
  6. Acceptable hematologic, hepatic, and renal function parameters.
  7. WHO Performance Status < 2.
  8. Subjects of reproductive potential must agree to follow accepted birth control methods.

Exclusion Criteria:

  1. Presence of lymphoma in CNS.
  2. Previous systemic anticancer treatment for NHL (including but not limited to radiation, myeloablative, or investigational therapy).
  3. Concurrent treatment with systemic steroids within 14 days of Day 1.
  4. Evidence of transformed lymphoma.
  5. 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).
  6. History of HIV infection or AIDS.
  7. Serious nonmalignant disease.
  8. Pregnant.
  9. Inability to comply with study and follow-up procedures.
  10. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug.

Please refer to: www.biogenideconcology.com

Please refer to the clinicaltrials.gov website for further details on the study: http://clinicaltrials.gov/ct2/show/NCT00651443

To contact Biogen, click here.

 
 
  
 
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