Trial | NCT01022255  Report issue

Title

Autologous Vaccine for Follicular Lymphoma
Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    28
This phase I study will evaluate the safety and tolerability of an autologous idiotype vaccine manufactured by magnICON technology for patients with relapsed follicular lymphoma who are in complete or partial remission following non-antiCD20 containing salvage therapy. Data in terms of idiotype-specific immune responses will also be obtained.
Study Started
Jan 31
2010
Primary Completion
Oct 31
2013
Study Completion
Oct 31
2013
Last Update
Jan 30
2014
Estimate

Biological Autologous FL vaccine

1.0 mg of vaccine subcutaneously (s.c.) on Day 1, and followed by 125 µg GM-CSF s.c. at Day 1 -4, monthly until 8th vaccination, bimonthly until 12th vaccination (month 16)

Arm 1 Experimental

Criteria 

Inclusion Criteria:

Subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in clinical relapse/progression requiring treatment
Subjects must have had first line treatment consisting of rituximab with or without rituximab maintenance therapy (i.e. rituximab monotherapy, R-CHOP, R-CVP, R-FND, etc)
At least 4 months since last rituximab exposure
Subjects may have had any number of prior treatment regimens. If enrolled with transformed follicular lymphoma, study subject must have had anthracycline in a previous regimen
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Life expectancy of at least 12 months
Presence of at least a 2x2 cm in diameter lymph node (either a single lymph node or combined volume of lymphoid tissue) accessible for excision; for histological confirmation of diagnosis and for manufacture of the vaccine
Measurable disease in neck, chest, abdomen, or pelvis as assessed by computed tomography (CT) scan such that response to 2nd line chemotherapy can be defined by the criteria of Cheson et al (JCO 2007; 25:579, see appendix 15.2 and ref 65). PET scan results are not required for enrollment

Exclusion Criteria:

Exposure to rituximab or antiCD-20 directed therapy within the 4 months prior to enrollment
History of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Active clinically serious infections (> grade 2 National Cancer Institute Common Toxic Criteria [NCI-CTC] version 3.0)
Symptomatic metastatic brain or meningeal tumors including lymphoma unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry
History of organ allograft
Patients undergoing renal dialysis
No Results Posted