NCT00530140

Brief Summary

Poor prognosis follicular lymphoma patients have an estimated median overall survival of 5-6 years. The proposed trial offers life-time idiotypic vaccination to all such patients in first relapse/progression who will achieve second (first, in the case of patients who have never achieved complete response following standard first-line treatment) complete response through autologous stem cell transplant prior to vaccination start. The ultimate goal is a cure, defined as a vaccine-maintained complete response lasting both at least 10 years and at least twice as long as each patient's first complete response.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
14 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 6, 2011

Status Verified

October 1, 2011

Enrollment Period

5.9 years

First QC Date

September 12, 2007

Last Update Submit

October 5, 2011

Conditions

Follicular LymphomaFirst Relapse/Progression

Keywords

Follicular LymphomaIdiotype vaccine

Outcome Measures

Primary Outcomes (1)

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

    15 years

Secondary Outcomes (1)

  • Percentage of patients who successfully maintain a measurable, specific immune response throughout the active vaccination time frame

    15 years

Study Arms (1)

A

EXPERIMENTAL

All patients will receive the same vaccination schedule/formulation

Biological: Follicular lymphoma, patient-specific, soluble protein idiotype vaccine

Interventions

Follicular lymphoma, patient-specific, soluble protein idiotype vaccineBIOLOGICAL

0.5 mg of idiotype conjugated to 0.5 mg of KLH + 125 mcg of GM-CSF 5 monthly vaccinations followed by 3 bi-monthly vaccinations, followed by one boost every three months until either relapse or death from cause unrelated to lymphoma

A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 transplant
  • Poor-prognosis genomic profiling

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Navarra Hospital

Pamplona, Navarre, 31008, Spain

RECRUITING

Related Publications (1)

  • Inoges S, Rodriguez-Calvillo M, Zabalegui N, Lopez-Diaz de Cerio A, Villanueva H, Soria E, Suarez L, Rodriguez-Caballero A, Pastor F, Garcia-Munoz R, Panizo C, Perez-Calvo J, Melero I, Rocha E, Orfao A, Bendandi M; Grupo Espanol de Linfomas/Trasplante Autologo de Medula Oseo study group; Programa para el Estudio y Tratamiento de Hemopatias Malignas study group. Clinical benefit associated with idiotypic vaccination in patients with follicular lymphoma. J Natl Cancer Inst. 2006 Sep 20;98(18):1292-301. doi: 10.1093/jnci/djj358.

    PMID: 16985248BACKGROUND

MeSH Terms

Conditions

Lymphoma, FollicularDisease Progression

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • MAURIZIO BENDANDI, MD, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MAURIZIO BENDANDI, MD, PhD

CONTACT

+34606002087mbendandi@unav.es

SUSANA INOGES, MD, PhD

CONTACT

+34685972257sinoges@unav.es

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 17, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2013

Study Completion

September 1, 2022

Last Updated

October 6, 2011

Record last verified: 2011-10

Locations

ES(1)