A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma
IIL INFL09
A Phase II Study of Bendamustine in Combination With Rituximab as Initial Treatment for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma
1 other identifier
interventional
73
1 country
25
Brief Summary
This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a chemoimmunotherapy with the combination of Bendamustine + Rituximab in patients with advanced untreated Indolent non Follicular non-Hodgkin Lymphomas (INFL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Typical duration for phase_2
25 active sites
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
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 22, 2013
CompletedFirst Posted
Study publicly available on registry
August 27, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedOctober 13, 2017
March 1, 2017
1.2 years
August 22, 2013
October 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete remission rate (CR)
Evaluated at the end of treatment
5 months
Secondary Outcomes (5)
Safety analysis
5 months
Overall response rate (ORR)
5 months
Overall survival (OS)
at 2 years
Progression free survival (PFS)
at 2 years
Disease free survival (PFS)
at 2 years
Study Arms (1)
Rituximab - Bendamustine (RB)
EXPERIMENTAL1 arm: Rituximab - Bendamustine (RB) 1 arm for all patients
Interventions
INDUCTION PHASE Rituximab - Bendamustine (RB): cycles 1 to 4 (0, 4, 8, 12 week): Rituximab: 375 mg/sqm iv, day 1\* Bendamustine: 90 mg/sqm iv, days 1-2 or days 2-3 according to istitutional/patient/physician choice Repeat cycles every 28 days for a total of 4 cycles \*In cycle 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8. CONSOLIDATION PHASE Rituximab - Bendamustine (RB): cycles 5 to 6 (16, 20 week): Rituximab: 375 mg/sqm iv day 1 Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to istitutional/patient/physician choice Rituximab two monthly doses Rituximab: 375 mg/sqm iv week 24 and 28
Eligibility Criteria
You may qualify if:
- Understand and voluntarily sign an informed consent form
- Histological (bone marrow or lymph nodes biopsy) proven diagnosis of B-cell CD20- positive non-follicular NHL according to REAL/WHO Classification:
- i. small lymphocytic lymphoma-SLL (bone marrow or lymph nodes biopsy ii. lymphoplasmacytic/citoid lymphoma/ Waldenstrom macroglobulinemia(bone marrow or lymph nodes biopsy) iii. nodal marginal zone lymphoma (lymph nodes biopsy)
- Untreated patients
- Stage III or IV or stage II with more than three involved sites
- Presence of at least one of the following criteria for the definition of active disease:
- Systemic symptoms
- Hemoglobin less than 10 g/dL (due to lymphoma)
- Platelets less than 100 x 10 9/L (due to lymphoma)
- Diffuse bone marrow infiltrate
- Lymphocyte doubling time less than 12 months (in leukemic cases)
- Bulky disease (\>7 cm)
- Aged 18 - 75 Life expectancy \>6 months
- ECOG performance status 0-2
- LVEF ≥45% or FS ≥37%
- +5 more criteria
You may not qualify if:
- Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin
- Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)
- Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
- History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
- Medical condition requiring long term use (\>1 months) of systemic corticosteroids
- Active bacterial, viral, or fungal infection requiring systemic therapy
- Concurrent medical condition which might exclude administration of therapy
- Cardiac insufficiency (NYHA grade III/IV)
- Myocardial infarction within 6 months of entry on study
- Severe chronic obstructive pulmonary disease with hypoxemia
- Severe diabetes mellitus difficult to control with adequate insulin therapy
- Hypertension that is difficult to control
- Impaired renal function with creatinine clearance \<30 ml/min
- HIV positivity
- HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive(these patientes need to receive prophylaxis with Lamivudine)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
SC Ematologia - AO SS. Antonio e Biagio e C. Arrigo
Alessandria, AL, 15121, Italy
SC Ematologia Spedali Civili
Brescia, BS, Italy
Divisione di Ematologia e Trapianti, Ospedale San Maurizio
Bolzano, BZ, Italy
Divisione di Ematologia, Centro Trapianto di Cellule Staminali
San Giovanni Rotondo, Foggia, Italy
Divisione Ematologia I , Ospedale San Martino
Genova, GE, Italy
S.C. Ematologia Azienda Ospedaliera Papardo
Messina, ME, Italy
Divisione di Oncologia Medica ed Ematologia, Istituto Clinico Humanitas
Rozzano, Milano, Italy
Divisione di Ematologia Ospedale Niguarda
Milan, MI, Italy
Centro Oncologico Modenese
Modena, MO, Italy
Ematologia Azienda Ospedaliero Universitaria Paolo Giaccone
Palermo, PA, Italy
Div. Oncologia Medica - CRO, Centro di Riferimento Oncologico
Aviano, PN, Italy
UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
Oncoematologia Istituto Pascale
Napoli, Italy
S.C.D.U Ematologia Azienda Ospedaliero Universitaria Maggiore
Novara, Italy
UO Ematologia Università - Policlinico San Matteo
Pavia, Italy
Ematologia Ospedale Santo Spirito
Pescara, Italy
UOA Ematologia, Ospedale Civile Ospedale G. da Saliceto
Piacenza, Italy
Div. Ematologia AO Bianchi Melacrino Morelli
Reggio Calabria, Italy
Ematologia, Azienda Ospedaliera Arcispedale "S.Maria Nuova"
Reggio Emilia, Italy
Ematologia, Università "La Sapienza"
Roma, Italy
Clinica Ematologia Policlino Le Scotte
Siena, Italy
Struttura Complessa di Onco-Ematologia Azienda Ospedaliera S.Maria
Terni, Italy
SC Ematologia - Città della Salute e della Scienza
Torino, Italy
SC Ematologia U - Città della Salute e della Scienza
Torino, Italy
Clinica Ematologica e Unità di Terapie Cellulari 'Carlo Melzi' AOU S. Maria della Misericordia
Udine, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luca Baldini, Prof.
UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2013
First Posted
August 27, 2013
Study Start
January 1, 2011
Primary Completion
March 1, 2012
Study Completion
May 1, 2015
Last Updated
October 13, 2017
Record last verified: 2017-03