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A phase III Multicenter,Randomized study comparing consolidation with 90yttrium-Labeled ibritumomab tiuxetan (Zevalin®) radioimmunotherapy vs autologous stem cell transplantation (ASCT) in patients with Relapsed/Refractory follicular lymphoma (FL) aged 18-65 years

NCT ID NCT01827605

NEW Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

159 people

The number who actually took part.

Start date

Jan 2012

Finished

Jan 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18-65 * Histologically documented diagnosis of grade I-IIIa FL defined according to WHO guidelines 2008 (Re-biopsy required) * Availability of BM and PB for Minimal Residual Disease (MRD) analysis (see Appendix I) * Relapsed or refractory disease after ≤ two chemotherapy lines at least one containing Rituximab (Rituximab maintenance is UNOTU considered a therapeutic line) * Clinical indication of treatment i.e. Stage II-IV who require therapy according to SIE and GELF criteria (see Appendix II) * ECOG performance status 0-2 (unless disease-related) (see Appendix III) * Availability of histological material for centralized revision * Laboratory values: * ANC ≥ 1500/mmc unless due to marrow involvement by lymphoma and/or platelets ≥ 100000/mmc unless due to marrow involvement by lymphoma * Serum creatinine ≤ 1.5 x ULN, unless it is disease related * Bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome) * AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN if not lymphoma related or ≤ 5.0 x ULN in case of lymphoma liver involvement * Adequate cardiac function: LVEF \> 50% by echocardiography or MUGA scan * Not pregnant or breast-feeding * Willingness to use effective contraception during the study and 3 months after the end of treatment * No other prior malignancies except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for ≥ 5 years (see Exclusion criteria 14) * Signed informed written consent Exclusion Criteria: * Grade IIIb FL, transformed FL or histologies different from FL * Previous treatment with \> two lines of chemotherapy ± rituximab Maintenance is UNOTU considered a therapeutics line) * Previous ASCT or RIT treatment * CNS involvement by lymphoma * HBV positivity with the exception of patients who are seropositive because of hepatitis B virus vaccination and patients HbcAb positive and HbsAg negative with undetectable serum HBV-DNA. Occult carriers: must receive treatment with Lamivudine 100 mg for the duration of treatment program and at least 12 months after treatment cessation; HBV-DNA levels and HBsAg will be monitored every month * HCV positivity with elevated transaminases or INR or APTT or active virus replication * HIV positivity * Any concurrent medical condition requiring long term use (\> one month) of systemic corticosteroids * Active bacterial, viral, or fungal infection requiring systemic therapy * Any concurrent medical or psychiatric condition which might impair administration of therapy or preclude the ability to give informed consent * Treatment with an experimental agent within 30 days prior to study entry * Myelosuppressive chemo or biological therapy within three weeks before study entry (use rituximab course delivered as maintenance is not an exclusion therapy) * Major surgery other than diagnosis within 4 weeks prior to study entry * Previous i.v. or i.m. treatments with murine or animal derived antibodies

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Conditions

The condition(s) this trial relates to.

follicular lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed follicular lymphoma

Contacts and locations

Locations

  • A O Papardo

    Messina, Italy

  • A.O. Niguarda

    Milan, MI, 20162, Italy

  • A.O. SS. Antonio e Biagio e C. Arrigo

    Alessandria, Alessandria, 15121, Italy

  • A.O.U. San Martino

    Genova, GE, 16132, Italy

  • Ausl Ravenna

    Ravenna, Italy

  • Azienda Ospedaliera "Bianchi Melacrino Morelli"

    Reggio Calabria, RC, 89125, Italy

  • Azienda Ospedaliera V. Cervello

    Palermo, Italy, 90146, Italy

  • Clinica di Ematologia - A.O.U. S. Maria di Udine

    Udine, Italy

  • Clinica di ematologia AOU Umberto I Ospedali Riuniti

    Ancona, Ancona, 60100, Italy

  • Divisione di Ematologia Osp. Businco

    Cagliari, Italy

  • Emat Univ - Città della salute e della scienza di Torino

    Torino, TO, 10126, Italy

  • Ematologia Policlinico San Matteo

    Pavia, Pavia, 27100, Italy

  • Ematologia con Trapianto Policlinico Universitario Consorziale

    Bari, Bari, 70124, Italy

  • Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori

    Milan, Milano, Italy

  • Ematologia, A.O. San Gerardo

    Monza, Milano, 20052, Italy

  • Filippo Gherlizoni

    Treviso, Italy

  • IRCC Onco-Ematologia

    Candiolo, Italy

  • IRCCS San Raffaele Unità di Chemioterapia

    Milan, Italy

  • IRCCS-Centro di riferimento oncologico UO di ematologia e Trapianto Cellule Staminali

    Rionero in Vulture, Potenza, 85028, Italy

  • Istituto Pascale Oncoematologia

    Naples, Italy

  • Ospedale Ferrarotto

    Catania, Italy

  • Ospedale Policlinico G.B. Rossi (Borgo Roma) Di Verona

    Verona, VR, 37126, Italy

  • Ospedale S. Francesco

    Nuoro, Italy

  • Ospedale San Bortolo

    Vicenza, VI, 36100, Italy

  • Ospedale Santa Maria della Misericordia

    Perugia, Italy

  • Ospedale Santo Spirito Dipartimento di Ematologia

    Pescara, Italy

  • Policlinico Careggi Clinica Ematologica

    Florence, Italy

  • Policlinico di Modena - Università degli studi

    Modena, Italy

  • Presidio Ospedaliero "A. Tortora"

    Pagani, SA, 84014, Italy

  • Presidio Ospedaliero A.Perrino - Divisione di Ematologia

    Brindisi, Italy

  • SC Ematologia AO Santa Maria Nuova IRCCS

    Reggio Emilia, Reggio Emilia, 42123, Italy

  • SC Ematologia Città della salute e della scienza di Torino

    Torino, Italy

  • SCDU Ematologia - Università del Piemonte Orientale

    Novara, Novara, 28100, Italy

  • Spedali Civili

    Brescia, Brescia, Italy

  • U.O. Complessa di Ematologia Ospedale di Parma

    Parma, Parma, 43100, Italy

  • UO Ematologia Osp. Cardinale Panico

    Tricase, Italy

  • Unità Ematologia Ospedale Civile di Piacenza

    Piacenza, Piacenza, 29100, Italy

  • Univeristà La Sapienza

    Roma, Italy

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