Recruitment

Recruitment Status
Completed

Inclusion Criterias

Alkaline phosphatase and transaminases up to 2 x ULN
Bulky disease (>7 cm)
Untreated patients
...
Alkaline phosphatase and transaminases up to 2 x ULN
Bulky disease (>7 cm)
Untreated patients
Lymphocyte doubling time less than 12 months (in leukemic cases)
Written informed content
Creatinine up to 1.5 x ULN
Aged 18 - 75 Life expectancy >6 months
Diffuse bone marrow infiltrate
Understand and voluntarily sign an informed consent form
Platelets less than 100 x 10 9/L (due to lymphoma)
Conjugated bilirubin up to 2 x ULN
ECOG performance status 0-2
Systemic symptoms
LVEF ≥45% or FS ≥37%
Stage III or IV or stage II with more than three involved sites
Hemoglobin less than 10 g/dL (due to lymphoma)
ANC ≥1 x 10 9/l and Platelets count ≥75 x 10 9/l, unless due to bone marrow involvement by follicular lymphoma

Exclusion Criterias

Women in pregnancy or breastfeeding
Cardiac insufficiency (NYHA grade III/IV)
Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
...
Women in pregnancy or breastfeeding
Cardiac insufficiency (NYHA grade III/IV)
Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin
Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)
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
Severe diabetes mellitus difficult to control with adequate insulin therapy
Active bacterial, viral, or fungal infection requiring systemic therapy
HCV positivity with the exception of patients with HCV RNA negative.
Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
Medical condition requiring long term use (>1 months) of systemic corticosteroids
HIV positivity
Hypertension that is difficult to control
Concurrent medical condition which might exclude administration of therapy
Participation at the same time in another study in with investiogational drugs are used
Severe chronic obstructive pulmonary disease with hypoxemia
Myocardial infarction within 6 months of entry on study
Impaired renal function with creatinine clearance <30 ml/min
CNS involvement by lymphoma
Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive(these patientes need to receive prophylaxis with Lamivudine)

Summary

Conditions
  • Indolent Non-follicular
  • Non-Hodgkin's Lymphoma
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

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). The study includes and induction phase and a ...

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). The study includes and induction phase and a consolidation phase.

Inclusion Criterias

Alkaline phosphatase and transaminases up to 2 x ULN
Bulky disease (>7 cm)
Untreated patients
...
Alkaline phosphatase and transaminases up to 2 x ULN
Bulky disease (>7 cm)
Untreated patients
Lymphocyte doubling time less than 12 months (in leukemic cases)
Written informed content
Creatinine up to 1.5 x ULN
Aged 18 - 75 Life expectancy >6 months
Diffuse bone marrow infiltrate
Understand and voluntarily sign an informed consent form
Platelets less than 100 x 10 9/L (due to lymphoma)
Conjugated bilirubin up to 2 x ULN
ECOG performance status 0-2
Systemic symptoms
LVEF ≥45% or FS ≥37%
Stage III or IV or stage II with more than three involved sites
Hemoglobin less than 10 g/dL (due to lymphoma)
ANC ≥1 x 10 9/l and Platelets count ≥75 x 10 9/l, unless due to bone marrow involvement by follicular lymphoma

Exclusion Criterias

Women in pregnancy or breastfeeding
Cardiac insufficiency (NYHA grade III/IV)
Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
...
Women in pregnancy or breastfeeding
Cardiac insufficiency (NYHA grade III/IV)
Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin
Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)
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
Severe diabetes mellitus difficult to control with adequate insulin therapy
Active bacterial, viral, or fungal infection requiring systemic therapy
HCV positivity with the exception of patients with HCV RNA negative.
Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
Medical condition requiring long term use (>1 months) of systemic corticosteroids
HIV positivity
Hypertension that is difficult to control
Concurrent medical condition which might exclude administration of therapy
Participation at the same time in another study in with investiogational drugs are used
Severe chronic obstructive pulmonary disease with hypoxemia
Myocardial infarction within 6 months of entry on study
Impaired renal function with creatinine clearance <30 ml/min
CNS involvement by lymphoma
Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive(these patientes need to receive prophylaxis with Lamivudine)

Locations

Torino
Novara
Piacenza
Terni
Siena
...
Torino
Novara
Piacenza
Terni
Siena
Torino
Roma
Bolzano, BZ
Reggio Calabria
Palermo, PA
Napoli
Modena, MO
Milano
Pescara
Genova, GE
Aviano, PN
Alessandria, AL, 15121
San Giovanni Rotondo, Foggia
Milano, MI
Reggio Emilia
Udine
Pavia
Rozzano, Milano
Messina, ME
Brescia, BS

Tracking Information

NCT #
NCT01929265
Collaborators
Not Provided
Investigators
  • Principal Investigator: Luca Baldini, Prof. UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • Luca Baldini, Prof. UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico