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Autologous Vaccine for Follicular Lymphoma

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ClinicalTrials.gov Identifier: NCT01022255
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
Icon Genetics GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoma, Follicular Biological: Autologous FL vaccine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma
Study Start Date : January 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Arm 1 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)




Primary Outcome Measures :
  1. Proportion of patients with toxicities as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI/CTCAE) version 3.0 grade >/= 3 to the magnICON generated idiotype (Id) vaccine [ Time Frame: One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values) ]

Secondary Outcome Measures :
  1. Assessment of humoral idiotype-specific immune responses [ Time Frame: One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values) ]
  2. Assessment of cellular idiotype-specific immune responses [ Time Frame: One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values) ]
  3. Long-term safety/tolerability as determined by the proportion of patients with toxicities as assessed by the FDA CBER Guidance for Industry Toxicity Grading Scale in Preventive Vaccine Clinical Trials and the NCI/CTCAE version 4.02 grade >/= 3 [ Time Frame: Up to the conclusion of a 12 cycle vaccination phase (month 16) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022255


Locations
United States, California
Burbank, California, United States, 91505
United States, Texas
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75390-8590
Sponsors and Collaborators
Icon Genetics GmbH
Investigators
Study Director: Company Study Director Icon Genetics

Additional Information:
Responsible Party: Icon Genetics GmbH
ClinicalTrials.gov Identifier: NCT01022255     History of Changes
Other Study ID Numbers: PMP0025-01
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014

Keywords provided by Icon Genetics GmbH:
autologous vaccine
follicular lymphoma
magnICON
plant-made vaccines
immune response

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vaccines
Immunologic Factors
Physiological Effects of Drugs