A Phase II Study for Patients With Indolent Non-follicular Non-Hodgkin's Lymphoma

NCT ID: NCT01929265

Last Updated: 2017-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2015-05-31

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).

Detailed 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 consolidation phase.

Conditions

Indolent Non-follicular; Non-Hodgkin's Lymphoma

Keywords

INFL; Indolent non-follicular; untreated INFL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab - Bendamustine (RB)

1 arm: Rituximab - Bendamustine (RB)

1 arm for all patients

Group Type: EXPERIMENTAL

Bendamustine

Intervention Type: DRUG

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

Interventions

Bendamustine

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

Intervention Type: DRUG

Other Intervention Names

RIBOMUSTIN

Eligibility Criteria

Inclusion Criteria

1. Understand and voluntarily sign an informed consent form

2. 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)

3. Untreated patients

4. Stage III or IV or stage II with more than three involved sites

5. Presence of at least one of the following criteria for the definition of active disease:

1. Systemic symptoms

2. Hemoglobin less than 10 g/dL (due to lymphoma)

3. Platelets less than 100 x 10 9/L (due to lymphoma)

4. Diffuse bone marrow infiltrate

5. Lymphocyte doubling time less than 12 months (in leukemic cases)

6. Bulky disease (>7 cm)

6. Aged 18 - 75 Life expectancy >6 months

7. ECOG performance status 0-2

8. LVEF ≥45% or FS ≥37%

9. ANC ≥1 x 10 9/l and Platelets count ≥75 x 10 9/l, unless due to bone marrow involvement by follicular lymphoma

10. Creatinine up to 1.5 x ULN

11. Conjugated bilirubin up to 2 x ULN

12. Alkaline phosphatase and transaminases up to 2 x ULN

13. Written informed content

Exclusion Criteria

1. Patients with diagnosis of marginal zone lymphoma of splenic or MALT origin

2. Patients with diagnosis of typical Chronic Lymphocytic Leukemia (CLL)

3. Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy

4. 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

5. Medical condition requiring long term use (>1 months) of systemic corticosteroids

6. Active bacterial, viral, or fungal infection requiring systemic therapy

7. Concurrent medical condition which might exclude administration of therapy

8. Cardiac insufficiency (NYHA grade III/IV)

9. Myocardial infarction within 6 months of entry on study

10. Severe chronic obstructive pulmonary disease with hypoxemia

11. Severe diabetes mellitus difficult to control with adequate insulin therapy

12. Hypertension that is difficult to control

13. Impaired renal function with creatinine clearance <30 ml/min

14. HIV positivity

15. HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive(these patientes need to receive prophylaxis with Lamivudine)

16. HCV positivity with the exception of patients with HCV RNA negative.

17. CNS involvement by lymphoma

18. Participation at the same time in another study in with investiogational drugs are used

19. Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

20. Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

21. Women in pregnancy or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Italiana Linfomi - ETS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Baldini, Prof.

Role: PRINCIPAL_INVESTIGATOR

UOC Ematologia 1/CTMO, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Locations

SC Ematologia - AO SS. Antonio e Biagio e C. Arrigo

Alessandria, AL, 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

Countries

Italy

Other Identifiers

IIL INFL09

Identifier Type: -

Identifier Source: org_study_id