Brief Induction Chemoimmunotherapy With Rituximab + Bendamustine + Mitoxantrone Followed by Rituximab in Elderly Patients With Advanced Stage Previously Untreated Follicular Lymphoma

Fondazione Italiana Linfomi - ETS37 sites in 1 country76 target enrollmentJune 2009

ConditionsFollicular Lymphoma

InterventionsRituximab, Mitoxantrone, Bendamustine

DrugsRituximab, Mitoxantrone, Bendamustine

Overview

Phase: Phase 2
Intervention: Rituximab, Mitoxantrone, Bendamustine
Conditions: Follicular Lymphoma
Sponsor: Fondazione Italiana Linfomi - ETS
Enrollment: 76
Locations: 37
Primary Endpoint: Complete Response (CR) Rate at the end of the consolidation phase
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone in elderly patients with advanced stage Follicular Lymphoma.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

January 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fondazione Italiana Linfomi - ETS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histological proven diagnosis of B-cell CD20+ follicular NHL, grade I, II and IIIa of WHO Classification
•Untreated patients with the exception of prior limited radiotherapy
•Stage III or IV who require therapy according to SIE and GELF criteria
•Stage II with at least one of the following:
•Bulky disease (\>7 cm)
•LDH \>normal
•Systemic symptoms
•Beta2-Microglobulin \>3 mg/l
•Extra-nodal involvement
•Active disease with rapid progression 5.Age from 65 to 80 years, geriatric score "FIT" (see Appendix B) 6.Life expectancy \>6 months 7.ECOG performance status 0-2 (see Appendix C) 8.LVEF ≥45% or FS ≥37% 9.ANC ≥1 x 109/l and Platelets count ≥75 x 109/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.Sending of bone marrow sample for Bcl-2/IgH rearrangement evaluation 14.Written informed content

Exclusion Criteria

•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; see Appendix D)
•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

Arms & Interventions

1

Rituximab will be supplied as 375 mg/sqm for i.v.administration.Mitoxantrone will be supplied as 8 mg/sqm for i.v.administration.Bendamustine will be supplied as 90 mg/sqm for i.v.administration.

Intervention: Rituximab, Mitoxantrone, Bendamustine

Outcomes

Primary Outcomes

Complete Response (CR) Rate at the end of the consolidation phase

Time Frame: 6 months

Proportion of CR according to the Cheson 2007 response criteria

Secondary Outcomes

Progression-free survival (PFS)(24 months)
Molecular response rate (Bcl2/IgH rearrangement)(24 months)
Molecular relapse rate(24 moths)
Incidence of grade 3 or greater overall toxicities measured by CTCAE v.3.0(24 months)
Overall survival (OS)(24 moths)