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Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lymphoma, Follicular

Thank you

Trial Information

Phase I Study of an Autologous Recombinant Idiotypic Vaccine Manufactured by magnICON® Technology for the Treatment of Patients With Relapsed or Transformed Follicular Lymphoma


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

One month after sixth vaccination (=7 month after achievement of tumour remission and recovery of normal blood values)

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

PMP0025-01

NCT ID:

NCT01022255

Start Date:

January 2010

Completion Date:

October 2013

Related Keywords:

  • Lymphoma, Follicular
  • autologous vaccine
  • follicular lymphoma
  • magnICON
  • plant-made vaccines
  • immune response
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

Fountain Valley, California  92708
Austin, Texas  78705