check_circleStudy Completed
Lymphoma, Follicular
Bayer Identifier:
PMP0025-01
ClinicalTrials.gov Identifier:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
28Trial Dates
January 2010 - October 2013Phase
Phase 1Could I Receive a placebo
NoProducts
Autologous FL vaccineAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Simmons Comprehensive Cancer Center, UT Southwestern Medical Center | Dallas, 75390-8590, United States |
Completed | Texas Oncology/Baylor Sammons Cancer Center | Dallas, 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) vaccinedate_rangeTime Frame:One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)enhanced_encryptionyesSafety Issue:
Secondary Outcome
- Assessment of humoral idiotype-specific immune responsesdate_rangeTime Frame:One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)enhanced_encryptionnoSafety Issue:
- Assessment of cellular idiotype-specific immune responsesdate_rangeTime Frame:One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)enhanced_encryptionnoSafety Issue:
- 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 >/= 3date_rangeTime Frame:Up to the conclusion of a 12 cycle vaccination phase (month 16)enhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1