Clinical trial NCT00169208 (phase 2, status: completed)
Conditions: follicular lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: rituximab, fludarabine, mitoxantrone
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, OCCNCCNC1=CC=C(NCCNCCO)C2=C1C(=O)C1=C(C(O)=CC=C1O)C2=O
Eligibility criteria:

        Inclusion Criteria:

          -  18 years < age < 75 years

          -  Pathologically confirmed low grade, follicular, B cell lymphoma (WHO Classification
             Follicular grades 1 and 2

          -  Failed at least first line chemotherapy with any standard anthracycline containing
             regimen (see appendix C for definition of treatment failure)

          -  Frozen biopsy material obtained at relapse or disease progression should be available
             for central pathology review and molecular biology studies

          -  The lymphoma must be CD20 positive (on the biopsy material obtained at relapse or
             disease progression)

          -  At least one measurable lesion one nodal or extranodal lesion

          -  WHO performance status grade 0 or 1

          -  Bulky disease at study entry according to the Groupe d'Etude des Lymphomes
             Folliculaires (GELF) criteria: Nodal or extranodal single mass > 7cm in its greatest
             diameter; systemic B-symptoms; increased lactate dehydrogenase (LDH) and beta 2
             macroglobulinemia (> 3mg/L); involvement of at least 3 nodal sites, each with a
             diameter of greater than 3 cm; splenic enlargement with margin below the umbilical
             line or cranio caudal diameter of greater than 20 cm; compression syndrome (ureteral,
             orbital, gastrointestinal), or pleural or peritoneal serous effusion.

          -  Patient information and written informed consent

        Exclusion Criteria:

          -  Evidence of histological transformation to diffuse large B-cell lymphoma

          -  > 2 prior treatment regimen

          -  Chemotherapy, or other experimental anticancer treatment during the 4 weeks before
             inclusion

          -  Any radiation therapy to the index lesion(s) during the 4 weeks before inclusion

          -  Autologous stem cell transplant during the 3 months before inclusion

          -  Prior treatment including fludarabine and / or mitoxantrone and / or rituximab or
             contra-indication to one of these products

          -  Unless exempted by the Responsible Investigator, as lymphoma related: serum creatinine
             >2 x Institutional Upper Limit of Normal (IULN), total bilirubin >2 x IULN or
             aspartate aminotransferase (AST) >2 x IULN, alkaline phosphatase >2 x IULN

          -  Low bone marrow function: absolute neutrophil count < 1500/mm3 and platelet < 100 x
             109/L at study entry (unless bone marrow infiltration)

          -  Clinically significant cardiac disease, as defined by history of symptomatic
             ventricular arrhythmias, congestive heart failure or myocardial infarction within 12
             months of study entry

          -  Evidence of symptomatic central nervous system disease

          -  Known positivity for HIV, hepatitis Bs antigen or hepatitis C

          -  Pregnant or lactating women. Women of childbearing potential, and all men, unwilling
             to take appropriate contraceptive measures during and for at least 6 months after
             cessation of therapy

          -  Patients considered for an autologous or allogenic stem transplant at time of primary
             treatment failure or relapse according to the rules of the respective centers

          -  Any uncontrolled serious non malignant condition or infection which would likely
             compromise the study objectives

          -  Previous evolutive malignancy within 5 years of study entry, with the exception of
             non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma

          -  Major surgery within 4 weeks prior to enrollment, unless patient has recovered from
             all treatment related toxicity

          -  Patient under tutelage.