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Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse

Phase 2
18 Years
65 Years
Open (Enrolling)
Follicular Lymphoma, First Relapse/Progression

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Trial Information

Idiotypic Vaccination for Poor-prognosis Follicular Lymphoma Patients in First Relapse

Idiotypic vaccination has already proved capable (in responding patients) of: biological
efficacy, that is the capacity of inducing an idiotype- and tumor-specific immune response
(Kwak LW et al. NEJM 1992); clinical efficacy, that is the capacity of inducing specific
immune responses able to kill in vivo follicular lymphoma cells that had survived
pre-vaccine chemotherapy (Bendandi M et al. Nature Med 1999): clinical benefit, that is the
capacity of prolonging survival of responding patients (Inoges et al. JNCI 2006). Now, we
want to test whether it is also capable of contributing to the ultimate goal of preventing
relapse indefinitely in responding patients.

Inclusion Criteria:

at least one of the following:

- FLIPI score 3 thru 5 at diagnosis and/or at relapse

- First complete response shorter than 3 years, if no maintenance (Interferon,
Rituximab, etc) treatment was administered, or than 5 years if maintenance treatment
was administered

- No treatment has been able to induce complete response until autologous stem cell

- Poor-prognosis genomic profiling

Exclusion Criteria: any of the following:

- Unavailability of a harvestable lymph node of at least cm 2x2x2

- Life expectancy < 1 year

- Abnormal heart or liver or kidney function

- ECOG Performance Status > 2

- Failure to sign informed consent before enrollment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of patients who both never relapse and have a second complete response longer than their first response (cured)

Outcome Time Frame:

15 years

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Navarra


Spain: Ministry of Health

Study ID:




Start Date:

October 2007

Completion Date:

September 2022

Related Keywords:

  • Follicular Lymphoma
  • First Relapse/Progression
  • Follicular Lymphoma
  • Idiotype vaccine
  • Lymphoma
  • Lymphoma, Follicular
  • Recurrence