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Autologous Vaccine for Follicular Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 1, 2009
Last Update Posted Date January 30, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01022255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2010)
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • 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) ]
  • 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) ]
  • Long-term safety/tolerability as determined by the proportion of patients with toxicities as assessed by the NCI/CTCAE version 3.0 grade >/= 3 to the magnICON generated Id vaccine [ Time Frame: Up to the conclusion of a 12 cycle vaccination phase (month 16) ]
  • Intra-individual comparison of duration of first versus second progression free survival for all patients [ Time Frame: At event of disease progression ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Vaccine for Follicular Lymphoma
Official Title  ICMJE Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Follicular
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: Arm 1
Intervention: Biological: Autologous FL vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2012)
28
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2009)
30
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022255
Other Study ID Numbers  ICMJE PMP0025-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Icon Genetics GmbH
Study Sponsor  ICMJE Icon Genetics GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Company Study Director Icon Genetics
PRS Account Icon Genetics GmbH
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP