Study 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

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

Trial Dates

January 2010 - October 2013

Phase

Phase 1

Could I Receive a placebo

Products

Autologous FL vaccine

Accepts Healthy Volunteer

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

Secondary Outcome

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)
Safety Issue:
no
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)
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
Time Frame:
Up to the conclusion of a 12 cycle vaccination phase (month 16)
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

Additional Information

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