check_circleStudy Completed

Lymphoma, Follicular

Bayer Identifier:

PMP0025-01

ClinicalTrials.gov Identifier:

NCT01022255

EudraCT Number:

Not Available

EU CT Number:

Not Available
Autologous vaccine for follicular lymphoma

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
28
Trial Dates
January 2010 - October 2013
Phase
Phase 1
Could I Receive a placebo
No
Products
Autologous FL vaccine
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Simmons Comprehensive Cancer Center, UT Southwestern Medical CenterDallas, 75390-8590, United States
Completed
Texas Oncology/Baylor Sammons Cancer CenterDallas, 75246, United States
Completed
Burbank, 91505, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)
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    Safety Issue:
    yes

Secondary Outcome

  • Assessment of humoral idiotype-specific immune responses
    date_rangeTime Frame:
    One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)
    enhanced_encryption
    Safety Issue:
    no
  • Assessment of cellular idiotype-specific immune responses
    date_rangeTime Frame:
    One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)
    enhanced_encryption
    Safety Issue:
    no
  • 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
    date_rangeTime Frame:
    Up to the conclusion of a 12 cycle vaccination phase (month 16)
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Phase I study of an autologous recombinant idiotypic vaccine manufactured by magnICON® technology for the treatment of patients with relapsed or transformed follicular lymphoma
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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