A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)
NCT ID: NCT01827605
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
159 participants
INTERVENTIONAL
2012-01-31
2024-01-31
Brief Summary
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Detailed Description
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This study will be conducted in six steps as follows. Screening Phase, Enrolment and Induction chemotherapy (STEP I) Randomization (STEP II) Stem cell mobilization and collection (STEP III) Consolidation (RIT vs ASCT) (STEP IV) Maintenance (STEP V) Follow-up Phase (STEP VI)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A RIT
Infusion of 90Y Ibritumomab Tiuxetan if the patient has less than 25% BM infiltration at the pre-consolidation restaging (0.4 mCi/kg if platelets ≥150,000/mmc, 0.3 mCi/kg if platelets are between 100.000 and 150,000/mmc). Zevalin® will be delivered as per indications and should thus be provided at expenses following regular supplies procedures.
ZEVALIN
Infusion of 90Y Ibritumomab Tiuxetan if the patient has less than 25% BM infiltration at the pre-consolidation restaging (0.4 mCi/kg if platelets ≥150,000/mmc, 0.3 mCi/kg if platelets are between 100.000 and 150,000/mmc).
ARM B ASCT
BEAM conditioning regimen (or in alternative FEAM regimen with fotemustine to replace BCNU) and reinfusion of CD34+ cells of ≥ 2x106/Kg CD34+ day 0 (optimal dose to reinfuse 4x106/Kg CD34+). G-CSF 5 mcg/Kg from day 2 until ANC\>1500/mmc. Patients who failed mobilization will directly proceed to rituximab maintenance
BEAM
BEAM REGIMEN day -6 Carmustine\* 300 mg/ m2 i.v. in 250ml dextrose 5% solution
from day -5 to day -2 Cytarabine 200 mg/m2 i.v. every 12 hours in 250 ml dextrose 5% solution, 250 ml/hr Etoposide 100 mg/m2 i.v. every 12 hours in 250 ml dextrose 5% solution, 250 ml/hr day -1 Melphalan 140 mg/m2 i.v. in 100ml saline solution in 200 ml/hr
day 0
UReinfusion of autologous stem cells following this rules:
1. Patient collecting ≥6x106 CD34+ cells/kg use \>4x106 CD34+ cells/kg for ASCT and keep \>2x106 CD34+ cells/kg for back up;
2. Patient collecting 4-6x106 CD34+ cells/kg use \>2x106 CD34+ cells/kg for ASCT and keep \>2x106 CD34+ cells/kg for back up;
3. Patient collecting 2-4x106 CD34+ cells/kg use all CD34+ cells for ASCT and keep no back up.
day 2 Filgrastim or Lenograstim 5μg/Kg s.c. until ANC \> 1500/mmc
Interventions
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ZEVALIN
Infusion of 90Y Ibritumomab Tiuxetan if the patient has less than 25% BM infiltration at the pre-consolidation restaging (0.4 mCi/kg if platelets ≥150,000/mmc, 0.3 mCi/kg if platelets are between 100.000 and 150,000/mmc).
BEAM
BEAM REGIMEN day -6 Carmustine\* 300 mg/ m2 i.v. in 250ml dextrose 5% solution
from day -5 to day -2 Cytarabine 200 mg/m2 i.v. every 12 hours in 250 ml dextrose 5% solution, 250 ml/hr Etoposide 100 mg/m2 i.v. every 12 hours in 250 ml dextrose 5% solution, 250 ml/hr day -1 Melphalan 140 mg/m2 i.v. in 100ml saline solution in 200 ml/hr
day 0
UReinfusion of autologous stem cells following this rules:
1. Patient collecting ≥6x106 CD34+ cells/kg use \>4x106 CD34+ cells/kg for ASCT and keep \>2x106 CD34+ cells/kg for back up;
2. Patient collecting 4-6x106 CD34+ cells/kg use \>2x106 CD34+ cells/kg for ASCT and keep \>2x106 CD34+ cells/kg for back up;
3. Patient collecting 2-4x106 CD34+ cells/kg use all CD34+ cells for ASCT and keep no back up.
day 2 Filgrastim or Lenograstim 5μg/Kg s.c. until ANC \> 1500/mmc
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
65 Years
ALL
No
Sponsors
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Fondazione Italiana Linfomi - ETS
OTHER
Responsible Party
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Principal Investigators
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Umberto Vitolo
Role: PRINCIPAL_INVESTIGATOR
AO Città della salute e della Scienza di Torino - Ospedale S. Giovanni Battista - TORINO
Marco Ladetto
Role: PRINCIPAL_INVESTIGATOR
AO SS. Antonio e Biagio e Cesare Arrigo Alessandria
Locations
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A.O.U. San Martino
Genova, GE, Italy
Ematologia, A.O. San Gerardo
Monza, Milano, Italy
A.O. Niguarda
Milan, MI, Italy
IRCCS-Centro di riferimento oncologico UO di ematologia e Trapianto Cellule Staminali
Rionero in Vulture, Potenza, Italy
Azienda Ospedaliera "Bianchi Melacrino Morelli"
Reggio Calabria, RC, Italy
Presidio Ospedaliero "A. Tortora"
Pagani, SA, Italy
Emat Univ - Città della salute e della scienza di Torino
Torino, TO, Italy
Ospedale San Bortolo
Vicenza, VI, Italy
Ospedale Policlinico G.B. Rossi (Borgo Roma) Di Verona
Verona, VR, Italy
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, , Italy
Clinica di ematologia AOU Umberto I Ospedali Riuniti
Ancona, , Italy
Ematologia con Trapianto Policlinico Universitario Consorziale
Bari, , Italy
Spedali Civili
Brescia, , Italy
Presidio Ospedaliero A.Perrino - Divisione di Ematologia
Brindisi, , Italy
Divisione di Ematologia Osp. Businco
Cagliari, , Italy
IRCC Onco-Ematologia
Candiolo, , Italy
Ospedale Ferrarotto
Catania, , Italy
Policlinico Careggi Clinica Ematologica
Florence, , Italy
A O Papardo
Messina, , Italy
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
Milan, , Italy
IRCCS San Raffaele Unità di Chemioterapia
Milan, , Italy
Policlinico di Modena - Università degli studi
Modena, , Italy
Istituto Pascale Oncoematologia
Napoli, , Italy
SCDU Ematologia - Università del Piemonte Orientale
Novara, , Italy
Ospedale S. Francesco
Nuoro, , Italy
Azienda Ospedaliera V. Cervello
Palermo, , Italy
U.O. Complessa di Ematologia Ospedale di Parma
Parma, , Italy
Ematologia Policlinico San Matteo
Pavia, , Italy
Ospedale Santa Maria della Misericordia
Perugia, , Italy
Ospedale Santo Spirito Dipartimento di Ematologia
Pescara, , Italy
Unità Ematologia Ospedale Civile di Piacenza
Piacenza, , Italy
Ausl Ravenna
Ravenna, , Italy
SC Ematologia AO Santa Maria Nuova IRCCS
Reggio Emilia, , Italy
Univeristà La Sapienza
Roma, , Italy
SC Ematologia Città della salute e della scienza di Torino
Torino, , Italy
Filippo Gherlizoni
Treviso, , Italy
UO Ematologia Osp. Cardinale Panico
Tricase, , Italy
Clinica di Ematologia - A.O.U. S. Maria di Udine
Udine, , Italy
Countries
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Other Identifiers
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FIL_FLAZ-12
Identifier Type: -
Identifier Source: org_study_id