Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05058404
Other study ID # FIL_FOLL19
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date December 1, 2021
Est. completion date July 2030

Study information

Verified date December 2023
Source Fondazione Italiana Linfomi - ETS
Contact Antonella Ferranti
Phone 0131033153
Email aferranti@filinf.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

FIL_FOLL19 is an open-label, multicenter, randomized phase III trial. The sponsor of this clinical trial is Fondazione Italiana Linfomi (FIL). The Primary Objective of the study is to demonstrate that, in patients with newly diagnosed, advanced stage Follicular Lymphoma (FL) with high tumor burden according to the Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, a treatment strategy that reduces the number of chemotherapy cycles in case of early response to immunochemotherapy is not inferior compared to standard therapy at full dose in terms of Progression-Free Survival (PFS).


Description:

This is an open-label, multicenter, randomized phase III trial. The study plans to randomize patients with a 1:1 ratio to Arm A (Standard arm) or Arm B (Experimental arm). Once randomized, each patient will start immunochemotherapy with one of the approved regimens (R-CHOP, R-Bendamustine, G-CHOP, G-Bendamustine, G-CVP) chosen by the physician on a patient basis before randomization. Patients randomized to Arm A will receive an induction immunochemotherapy at full doses (standard schedule). After cycle 4, patients will be assessed for response and will complete their planned therapy if at least a stable disease is confirmed. Patients randomized to Arm B will start their induction treatment with 4 cycles of the immunochemotherapy standard dose chosen by the physician: after cycle 4, patients will be assessed for response and will proceed with subsequent treatment based on the quality of their response. Specifically: - Patients achieving a Complete Remission (CR) will receive a shortened treatment: in detail, they won't receive any further chemotherapy but will complete induction with 4 additional cycles of only the Monoclonal Antibody (MoAb) given during the first four cycles (in case of G-bendamustine, 2 additional cycles of obinutuzumab); - In case if response less than Complete Remission (CR), Partial Remission (PR) or Stable Disease (SD), patients will complete treatment as planned for patients in Arm A. In both arms, at the end of induction responding patients (CR, PR) will be addressed to a standard anti-CD20 maintenance (1 dose every 8 weeks for two years) with the same Monoclonal Antibody (MoAb) given during induction. Patients with progressive disease at any time (regardless of treatment arm) will be addressed to salvage therapy. The study plans the evaluation of quality of life by collecting the Patient-Reported Outcome(s) (PROs) through the Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym questionnaire) at predetermined timepoints during the study.


Recruitment information / eligibility

Status Recruiting
Enrollment 602
Est. completion date July 2030
Est. primary completion date July 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Histologically documented diagnosis of CD20+ Follicular lymphoma grade 1-2 or 3a, as defined in the 2017 edition of the World Health Organization (WHO) classification; 2. Age = 18 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix B); 4. No previous immunochemotherapy for the lymphoma (localized radiotherapy or rituximab monotherapy with max of 4 doses are allowed); 5. Ann Arbor stage II-IV (Appendix A); 6. High tumor burden as per Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria defined as the presence of at least one of the following: - systemic symptoms; - Tumor bulk (any nodal or extranodal tumor mass with diameter > 7 cm); - involvement of = 3 nodal sites, each with a diameter = 3 cm; - splenomegaly; - compressive syndrome (organ compression); - serous effusion; - circulant malignant cells; - cytopenia; - Eastern Cooperative Oncology Group - Performance Status (ECOG-PS) > 1; - Lactate dehydrogenase (LDH) > upper limit of normality (ULN); - ß2-microglobulin > 3 mg/L. 7. At least one site of measurable nodal disease at baseline = 1.5 cm in the longest transverse diameter as determined by CT scan (MRI is allowed if CT scan cannot be performed); or evaluable disease at baseline FDG-PET (18F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET)) scan (at least one metabolic active site of disease); 8. Adequate hematological counts (unless due to bone marrow involvement by lymphoma) defined as follows: 1. Absolute Neutrophil count (ANC) > 1.5 x 109/L; 2. Platelet count = 80 x 109/L ; 3. Hemoglobin = 10 g/dL. 9. Adequate renal function defined as creatinine = 2 mg/dL, unless secondary to lymphoma; 10. Adequate hepatic function defined as bilirubin = 2 mg/dL, unless secondary to lymphoma; 11. Left Ventricular Ejection Fraction (LVEF) > 50% at bidimensional echocardiogram (mandatory only for patients receiving R/G-CHOP); 12. Life expectancy = 6 months; 13. Subject understands and voluntarily signs an informed consent form approved by an Independent Ethics Committee (IEC) prior to the initiation of any screening or study-specific procedures; 14. Subject must be able to adhere to the study visit schedule and other protocol requirements; 15. Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 12 months after last rituximab dose or 18 months after last obinutuzumab dose. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control (failure rate of less than 1%) e.g., intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner. The use of condoms by male patients is required (even if surgically sterilized, i.e., status post vasectomy) unless the female partner is permanently sterile. Full sexual abstinence is admitted when this is in line with the preferred and usual lifestyle of the subject, for the same time period planned for other methods of birth control (see above). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods for the female partner) and withdrawal are not acceptable methods of contraception). Exclusion Criteria: 1. Histological diagnosis different from FL grade 1-3a WHO 2017 classification; 2. Suspect or clinical evidence of Central Nervous System (CNS) involvement by lymphoma; 3. Contraindication to the use of anti-CD20 monoclonal antibodies; 4. Subject has received any anticancer therapy (chemotherapy, immunotherapy, investigational therapy, including targeted small molecule agents) within 14 days prior to the first dose of study drug; 5. Noteworthy history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent; 6. Any history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uterine; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; limited stage surgically removed breast cancer or adequately treated with radiation therapy; limited stage prostate carcinoma surgically removed or adequately treated with radiation therapy; previous malignancy confined and surgically resected with curative intent; 7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: - Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2; - Chronic or acute hepatitis B (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e., HBsAg negative, HBsAb positive and HBcAb negative) or positive HBcAb from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if Polymerase Chain Reaction (PCR) negative for HCV-RNA; 8. Women who are pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Immunochemotherapy regimen: Rituximab-bendamustine (Arm A)
Arm A (Standard arm): 4 cycles of Rituximab-bendamustine Q28 (28-days cycles); Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of R-bendamustine Q28 + 2 cycles Q28 of rituximab; Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.
Immunochemotherapy regimen: Rituximab-bendamustine (Arm B)
Arm B (Experimental arm): 4 cycles of Rituximab-bendamustine Q28 (28-days cycles); After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified: if in CR: patients will receive no more chemotherapy but will complete induction with the MoAb only, in this case: 4 cycles of rituximab; if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of R-bendamustine Q28 + 2 cycles Q28 of rituximab; Both Arms: Whichever the regimen, in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.
Immunochemotherapy regimen: R-CHOP (Arm A)
Arm A (Standard arm): 4 cycles of R-CHOP Q21 (21-days cycles); R-CHOP = Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of R-CHOP Q21 + 2 cycles Q21 of rituximab; Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion: these patients will be included in the analysis planned by the study.
Immunochemotherapy regimen: R-CHOP (Arm B)
Arm B (Experimental arm): 4 cycles of R-CHOP Q21 (21-days cycles); R-CHOP = Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone After cycle 4 patients will undergo an early restaging: induction therapy shall be completed based on the response achieved and on the treatment chosen: if in CR: patients will receive no more chemotherapy but will complete induction with the MoAb only, in this case: 4 cycles of rituximab; if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of R-CHOP Q21+ 2 cycles Q21of rituximab Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction. Patients in both arms with progressive disease at any time and patients in SD at the EOI shall be considered for salvage therapy at clinician discretion: these patients will be included in the analysis.
Immunochemotherapy regimen: G-bendamustine (Arm A)
Arm A (Standard arm): 4 cycles of G-bendamustine Q28 (28-days cycles); G-Bendamustine = Obinutuzumab and Bendamustine Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of G-bendamustine Q28 (28-days cycles); Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in Stable Disease SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.
Immunochemotherapy regimen: G-bendamustine (Arm B)
Arm B (Experimental arm): 4 cycles of G-bendamustine Q28 (28-days cycles); G-Bendamustine = Obinutuzumab and Bendamustine After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified: if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case 2 cycles of obinutuzumab; if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of G-bendamustine Q28; Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.
Immunochemotherapy regimen: G-CHOP (Arm A)
Arm A (Standard arm): 4 cycles of G-CHOP Q21 (21-days cycles) G-CHOP = Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of G-CHOP Q21 + 2 cycles Q21 of obinutuzumab; Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.
Immunochemotherapy regimen: G-CHOP (Arm B)
4 cycles of G-CHOP Q21 (21-days cycles) G-CHOP = Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified: if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case: 4 cycles of obinutuzumab; if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of G-CHOP Q21 + 2 cycles Q21 of obinutuzumab; Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction. Patients in both arms with progressive disease at any time and patients in SD at the EOI shall be considered for salvage therapy at clinician discretion.
Immunochemotherapy regimen: G-CVP (Arm A)
Arm A (Standard arm): 4 cycles of G-CVP Q21 (21-days cycles) G-CVP = Obinutuzumab, Cyclophosphamide, Vincristine, Prednisone. Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 4 cycles of G-CVP Q21; Both Arms: Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction. Patients in both arms with progressive disease at any time and patients in stable disease SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.
Immunochemotherapy regimen: G-CVP (Arm B)
Arm B (Experimental arm): 4 cycles of G-CVP Q21 (21-days cycles) G-CVP = Obinutuzumab, Cyclophosphamide, Vincristine, Prednisone. After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified: if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case: 4 cycles of obinutuzumab; if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 4 cycles of G-CVP Q21 Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction. Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion.

Locations

Country Name City State
Italy A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia Alessandria
Italy AOU Ospedali Riuniti - Clinica di Ematologia Ancona
Italy Ospedale C.e G. Mazzoni - U.O.C. di Ematologia Ascoli Piceno
Italy Azienda Ospedaliera S.Giuseppe Moscati - S.C. Ematologia e Trapianto emopoietico Avellino
Italy IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati Aviano Pordenone
Italy AOU Policlinico Consorziale - U.O. Ematologia con Trapianto Bari
Italy IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia Bari
Italy Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia Barletta Barletta Andria Trani
Italy Ospedale S. Martino - UOC Oncologia Belluno
Italy A.O.R.N. Gaetano Rummo - DH Ematologico Benevento
Italy Nuovo Ospedale degli Infermi - SSD Ematologia Biella
Italy ASST Spedali Civili di Brescia - Ematologia Brescia
Italy Ospedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo Brindisi
Italy ASST Valle Olona - Ospedale di Circolo di Busto Arsizio - S.C. Ematologia Busto Arsizio Varese
Italy Fondazione del Piemonte per l'Oncologia - IRCCS - Ematologia Candiolo Torino
Italy Ospedale di Castelfranco Veneto - Ematologia Castelfranco Veneto Treviso
Italy Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele Presidio Ospedale Ferrarotto - Ematologia Catania
Italy AO Pugliese Ciaccio - SOC Ematologia Catanzaro
Italy Azienda Ospedaliera di Cosenza - UOC Ematologia Cosenza
Italy A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo Cuneo
Italy Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna - Ematologia e fisiopatologia della coagulazione Ferrara
Italy Azienda Ospedaliera Universitaria Careggi - Unit? funzionale di Ematologia Firenze
Italy Ospedale San Giovanni di Dio - SOS Ematologia clinica e oncoematologia ASL Toscana Centro Firenze
Italy Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l Oncologia - Ematologia Genova
Italy Ospedale Vito Fazzi - Ematologia Lecce
Italy IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L. - Ematologia Meldola Forlì - Cesena
Italy Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia Messina
Italy Ospedale Dell'Angelo - U.O. Ematologia Mestre Venezia
Italy ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia Milano
Italy ASST Santi Paolo e Carlo - Onco - Ematologia Milano
Italy Istituto Scientifico San Raffaele - Unit? Linfomi - Dipartimento Oncoematologia Milano
Italy Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda - Ematologia Milano
Italy USLL13 - Dipartimento di Scienze Mediche UOC di Oncologia ed Ematologia Oncologica Mirano Venezia
Italy ASST MONZA Ospedale S. Gerardo - Ematologia Monza Monza E Brianza
Italy AOU Universit? degli Studi della Campania Luigi Vanvitelli - Oncologia Medica ed Ematologia Napoli
Italy AOU Maggiore della Carit? di Novara - SCDU Ematologia Novara
Italy AOU di Padova - Ematologia Padova
Italy I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1 Padova
Italy Presidio ospedaliero "A. TORTORA" - U.O. Onco-ematologia Pagani Salerno
Italy A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia Palermo
Italy AOU Policlinico Giaccone - Ematologia Palermo
Italy UO Ematologia e CTMO - AOU di Parma Parma
Italy IRCCS Policlinico S. Matteo di Pavia - Div. di Ematologia Pavia
Italy P.O. Spirito Santo di Pescara - UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi Pescara
Italy Ospedale Guglielmo da Saliceto - U.O.Ematologia Piacenza
Italy AOU Pisana - U.O. Ematologia Pisa
Italy A.O.R. "San Carlo" - U.O. Ematologia Potenza
Italy Ospedale S. Stefano - SOS Oncoematologia, ASL Toscana Centro Prato
Italy Ospedale delle Croci - Ematologia Ravenna
Italy Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Ematologia Reggio Calabria
Italy Azienda Unit? Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia Reggio Emilia
Italy Ospedale degli Infermi di Rimini - U.O. di Ematologia Rimini
Italy Ospedale S. Camillo - Ematologia Roma
Italy Ospedale S. Eugenio - UOC Ematologia Roma
Italy Policlinico Tor Vergata - Ematologia Roma
Italy Policlinico Umberto I - Universit? "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione Roma
Italy Universit? Cattolica S. Cuore - Ematologia Roma
Italy Ospedale di Rovigo - S.O.S. Oncoematologia Rovigo
Italy Ematologia e Trapianti A.O. San Giovanni di Dio e Ruggi D Aragona - U.O. Ematologia Salerno
Italy Casa Sollievo della Sofferenza - U.O. Ematologia San Giovanni Rotondo Foggia
Italy AOU di Sassari - Ematologia Sassari
Italy Nuovo Ospedale Civile di Sassuolo - Day Hospital Oncologico Sassuolo Modena
Italy AOU Senese - U.O.C. Ematologia Siena
Italy Azienda Ospedaliera della Valtellina e della Valchiavenna P.O. Sondrio - Medicina Interna - Centro Malattie del Sangue P.O. Sondrio Sondrio
Italy A.O. S. Maria di Terni - S.C. Oncoematologia Terni
Italy A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria Torino
Italy A.O.U. Citta della Salute e della Scienza di Torino - S.C.Ematologia Torino
Italy San Giovanni Bosco - ASL Citt? di Torino - SSD di Ematologia e Malattie Trombotiche Torino
Italy Ospedale Ca Foncello - S.C di Ematologia Treviso
Italy A.O. C. Panico - U.O.C Ematologia e Trapianto Tricase Lecce
Italy Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia Trieste

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Italiana Linfomi - ETS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival (PFS) The length of time during and after the treatment that patients live with the disease, but it does not get worse. Progression-Free Survival (PFS) will be measured from the time of study entry to documented progression or to the patient's death as a result of any causes. Subjects with incomplete follow-up or with no disease evaluation will be censored at the date of last available documented status of freedom from failure. The endpoint will be assessed from the beginning of the study up to 104 months (end of study)
Secondary Overall Survival (OS) Overall Survival, the percentage of patients alive, will be measured from the time of study entry to death from any cause. Patients who have not died at the time of the final analysis will be censored at the date of the last contact. The endpoint will be assessed from the beginning of the study up to 104 months (end of study)
Secondary Event-Free Survival (EFS) The measure of time after treatment that patients have not have cancer come back or get worse. It will be measured from the time of study entry to any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g., disease progression, toxicity, patient preference, initiation of a new treatment without documented progression) or death from any cause. The endpoint will be assessed from the beginning of the study up to 104 months (end of study)
Secondary Overall Response rate (ORR) Overall response rate (ORR) is defined as the proportion of patients who have a partial or complete response to therapy; It will be defined according to Response Criteria for Non-Hodgkin Lymphoma (NHL) with Positron Emission Tomography (PET) (Lugano 2014). ORR will include the sum of patients in Complete Remission and Partial Remission (CR + PR). It will be evaluated on assessed patients and on all treated patients, considering patients without a response assessment (due to any reason) as non-responders.
The best overall response will be defined as the best response between the date of beginning of therapy and the last restaging.
The endpoint will be assessed from the beginning of the study up to 104 months (end of study)
Secondary Complete response rate (CRR) The Complete Response Rate is defined as the percentage of patient in Complete Remission. It will be defined according to Response Criteria for Non-Hodgkin Lymphoma (NHL) with Positron Emission Tomography (PET) (Lugano 2014). CRR will include only patients in Complete Remission (CR). It will be evaluated on assessed patients and on all treated patients, considering patients without a response assessment (due to any reason) as non-responders. The endpoint will be assessed from the beginning of the study up to 104 months (end of study)
Secondary Molecular response Molecular response assessed by means of the evaluation of the Bcl2/IgH rearrangement at baseline and of the Minimal Residual Disease (MRD) at subsequent defined timepoints. The endpoint will be assessed from the beginning of the study up to 104 months (end of study)
Secondary Incidence of toxicities (Safety of the treatment) Safety of the treatment according to the current version of the CTCAE. Incidence of toxicities The endpoint will be assessed from the beginning of the study up to 104 months (end of study)
Secondary Patient-Reported Outcomes (PROs) Health Related Quality of Life (HR-QoL) will be evaluated by means of Patient-Reported Outcome(s) PROs. Patients will be asked to complete the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) questionnaire at prespecified points during the study. The questionnaire results will be analyzed according to recommendations of the instrument scoring procedures. The endpoint will be assessed from the beginning of the study up to 104 months (end of study)
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT01804686 - A Long-term Extension Study of PCI-32765 (Ibrutinib) Phase 3
Completed NCT00001512 - Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines Phase 1
Recruiting NCT03676504 - Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR Phase 1/Phase 2
Active, not recruiting NCT03078855 - A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma Phase 3
Active, not recruiting NCT03245021 - Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A Phase 1
Recruiting NCT05365659 - IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas Phase 1
Active, not recruiting NCT04082936 - A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT02213263 - A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06) Phase 3
Completed NCT01691898 - A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL) Phase 1/Phase 2
Terminated NCT03585725 - A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma Early Phase 1
Terminated NCT00772668 - Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL N/A
Recruiting NCT02892695 - PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma Phase 1/Phase 2
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Terminated NCT02204982 - Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma Phase 3
Completed NCT02536664 - Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
Terminated NCT00850499 - Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab Phase 2
Terminated NCT00475332 - Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar Phase 2
Terminated NCT00136591 - A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma Phase 2
Not yet recruiting NCT06068881 - A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation Phase 2
Active, not recruiting NCT04034056 - Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)