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

Phase 2

Completed

• Conditions: Indolent Non-follicular; Non-Hodgkin's Lymphoma
• Interventions: Drug: Bendamustine

• Registration Number: NCT01929265
• Lead Sponsor: Fondazione Italiana Linfomi - ETS

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-03
• Study First Submitted: 2013-08-22
• Study First Submitted QC: 2013-08-22
• Study First Posted: 2013-08-27
• Study Completion: 2015-05
• Status Verified: 2017-03
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab - Bendamustine (RB)	Bendamustine	1 arm: Rituximab - Bendamustine (RB) 1 arm for all patients

Primary Outcome Measures

Name	Time	Method
Complete remission rate (CR)	5 months	Evaluated at the end of treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	at 2 years	Dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.
Safety analysis	5 months	Evaluated during and at the end of treatment. Percentage of patients with adverse, hematological and non-hematological toxic events
Overall response rate (ORR)	5 months	Evaluated at the end of treatment. Complete plus partial remission.
Disease free survival (PFS)	at 2 years	Relapse or dead for any causes from the end of treatment, for patients in CR after B+R. Evaluated by means of Kaplan-Meier method.
Progression free survival (PFS)	at 2 years	Progression, relapse or dead for any causes after diagnosis. Evaluated by means of Kaplan-Meier method.

Trial Locations

Locations (25)

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; 🇮🇹 Milano, MI, Italy

Centro Oncologico Modenese; 🇮🇹 Modena, MO, Italy

Ematologia Azienda Ospedaliero Universitaria Paolo Giaccone; 🇮🇹 Palermo, PA, Italy

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