Trial Condition(s):

Lymphoma, Follicular

Autologous vaccine for follicular lymphoma

Bayer Identifier:

PMP0025-01

ClinicalTrials.gov Identifier:

NCT01022255

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
28
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Autologous FL vaccine
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Simmons Comprehensive Cancer Center, UT Southwestern Medical Center

Dallas, United States, 75390-8590

Status
Completed
 
Locations

Texas Oncology/Baylor Sammons Cancer Center

Dallas, United States, 75246

Status
Completed
 
Locations

Investigative Site

Burbank, United States, 91505

Status
Completed
 

Trial Design