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

Phase 2
65 Years
80 Years
Open (Enrolling)
Follicular Lymphoma

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Trial Information

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

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 5. 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

- Impaired renal function with creatinine clearance <30 ml/min (see Appendix E)

- HIV positivity

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

- HCV positivity with the exception of patients with no laboratory signs of active
chronic hepatitis and HCV-RNA negativity

- CNS involvement by lymphoma 16. Participation at the same time in another study in
which investigational drugs are used

- Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

Proportion of CR according to the Cheson 2007 response criteria

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Umberto Vitolo, MD

Investigator Role:

Study Director

Investigator Affiliation:

Azienda Sanitaria Ospedaliera-Universitaria S. Giovanni Battista - TORINO


Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:




Start Date:

June 2009

Completion Date:

December 2014

Related Keywords:

  • Follicular Lymphoma
  • Lymphoma
  • Lymphoma, Follicular