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A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase 2 Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Patient-Specific Immunotherapy, Recombinant Idiotype Conjugated to KLH (Id-KLH) and Administered With GM-CSF, in Patients With Follicular Non-Hodgkin's Lymphoma (fNHL) Following Primary Treatment With Rituximab and Chemotherapy (R-Chemo)


Inclusion Criteria:



1. Written informed consent

2. Previously untreated follicular NHL

3. Stage III or IV disease requiring treatment

4. Able to receive rituximab and chemotherapy (rituximab with cyclophosphamide,
vincristine, and prednisone either with or without doxorubicin)

5. Able to provide tumor sample adequate for Id-KLH manufacture

6. ≥ 18 years of age

7. At least one bi-dimensionally measurable lesion ≥ 2 cm by CT scan

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Authority:

United States: Food and Drug Administration

Study ID:

2007-12

NCT ID:

NCT00510471

Start Date:

May 2007

Completion Date:

Related Keywords:

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

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Rocky Mountain Cancer CentersThornton, Colorado  80260
Indiana University Medical CenterIndianapolis, Indiana  46202
Weill Medical College of Cornell University, NY Presbyterian HospitalNew York, New York  10021
University of Oklahoma Health Science CenterOklahoma City, Oklahoma  73104
Keck School of Medicine of University Southern CaliforniaLos Angeles, California  90089
Providence Portland Cancer CenterPortland, Oregon  97213