Who is sponsoring NCT01329354?

NCT01329354 is sponsored by Clinica Universidad de Navarra, Universidad de Navarra.

What drugs are being tested in NCT01329354?

Interventions in NCT01329354: Autologous effector lymphocytes expanded ex-vivo.

What condition does NCT01329354 study?

NCT01329354 studies Follicular Lymphoma, Follicular Non-Hodgkin´s Lymphoma, Autologous Effector Lymphocytes.

Is NCT01329354 still recruiting?

NCT01329354 is currently status unknown. Last updated 23 October 2017.

Last reviewed 2017-10-23 · How we verify

NCT01329354

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase II Clinical Trial of Immunotherapy With Rituximab and Autologous Effector Lymphocytes in Patients With Non-Hodgkin Follicular Lymphoma in Response to First Line Chemotherapy

Status unknown Phase 2 Last updated 23 October 2017

What this trial tests

Phase 2 trial testing Autologous effector lymphocytes expanded ex-vivo in Follicular Lymphoma in 38 participants. Status unknown.

Timeline

1 March 2011

Primary endpoint
1 November 2019

1 November 2019

Quick facts

Lead sponsor	Clinica Universidad de Navarra, Universidad de Navarra
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	1 March 2011
Primary completion	1 November 2019
Estimated completion	1 November 2019
Sites	1 location across Spain

Drugs / interventions tested

Autologous effector lymphocytes expanded ex-vivo — full drug profile →

Conditions studied

Follicular Lymphoma — all drugs for Follicular Lymphoma →
Follicular Non-Hodgkin´s Lymphoma — all drugs for Follicular Non-Hodgkin´s Lymphoma →
Autologous Effector Lymphocytes — all drugs for Autologous Effector Lymphocytes →

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Who can join

Adults 18 to 75, any sex, with Follicular Lymphoma or Follicular Non-Hodgkin´s Lymphoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Progression free survival (PFS) from the entry in the study.
Time frame: 01/03/2015
The PFS is defined as the time from the entry in the study up to the progression of the disease.

Sponsor's own description

Nowadays, therapy with monoclonal antibodies is considered to be a standard treatment that increases the rate of remissions and the overall survival in patients with follicular lymphoma. Nevertheless there are an important number of patients who do not benefit from this therapy. A way to improve the efficiency of monoclonal antibodies therapy could be to improve the activity of the effector arm of the immune system. A strategy that has been proposed to obtain this improvement is the utilization of lymphocyte activated killer (LAK) cells. In addition, the combination of LAK cells with monoclonal antibodies might obtain an additive effect across the stimulation of the antibody dependent cellular cytotoxicity (ADCC)activity. The present clinical assay proposes to study the feasibility, safety and effectiveness of treatment with autologous effector cells expanded ex vivo associated with a standard maintenance treatment with rituximab in patients with follicular lymphoma in remission after first-line treatment. In addition, we plan to analyse various biological parameters that can predict the susceptibility of patients to treatment with rituximab. Specifically, we propose to study the polymorphisms of Fc receptor, polymorphisms related to the ability of complement activation, to study both the complement activity and peripheral blood cell subpopulations that can mediate directly or indirectly dependent antibody cytotoxic effect. We will also try to correlate any of these biological parameters with the response to treatment.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Combination strategies to enhance antitumor ADCC.
Kohrt HE, Houot R, Marabelle A, Cho HJ, et al · · 2012 · cited 76× · PMID 22642334 · DOI 10.2217/imt.12.38
Follicular lymphoma: in vitro effects of combining lymphokine-activated killer (LAK) cell-induced cytotoxicity and rituximab- and obinutuzumab-dependent cellular cytotoxicity (ADCC) activity.
García-Muñoz R, López-Díaz-de-Cerio A, Feliu J, Panizo A, et al · · 2016 · cited 10× · PMID 26659089 · DOI 10.1007/s12026-015-8747-9
GALLIUM trial: the tortoise (rituximab) and the hare (obinutuzumab) race.
García-Muñoz R, Anton-Remirez J, Nájera MJ, Gutierrez-Gamarra E, et al · · 2019 · cited 3× · PMID 30906570 · DOI 10.4155/fsoa-2018-0122
LVII CONGRESO NACIONAL DE LA SOCIEDAD ESPAÑOLA DE HEMATOLOGÍA Y HEMOTERAPIA, VALENCIA, SPAIN, 22–24 DE OCTUBRE, 2015
· 2015

Verify or expand the search:

Other recruiting trials for Follicular Lymphoma

Currently open trials in the same condition.

NCT07128641 — Odronextamab in Low Tumor Volume Advanced FL · Phase 2 · recruiting
NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL · Phase 2 · recruiting
NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
NCT07126678 — Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma · NA · recruiting
NCT06860880 — Combating Cancer-Related Fatigue: A Personalized Supportive Care Program · NA · recruiting

Other Clinica Universidad de Navarra, Universidad de Navarra trials

Trials by the same sponsor.

NCT07370571 — NO AXILLARY SURGERY IN EARLY BREAST CANCER (OXIGENATE) · not yet recruiting
NCT07165431 — Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2). · NA · recruiting
NCT07447440 — Role of Pro-Resolving Lipid Mediators in Obesity-Associated Diseases · recruiting
NCT07191210 — Co-Designed Comprehensive Transition Programme for First-Line Nurse Managers · NA · not yet recruiting
NCT07132060 — MRI-guided Dose Intensification Program Locally Advanced Pancreatic Cancer · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01329354 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Clinica Universidad de Navarra, Universidad de Navarra
Last refreshed: 23 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01329354.

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