Clinical trial NCT00003204 (phase 3, status: completed)
Conditions: stage iii grade 1 follicular lymphoma, stage iii grade 2 follicular lymphoma, stage iii grade 3 follicular lymphoma, stage iii small lymphocytic lymphoma, stage iv grade 1 follicular lymphoma, stage iv grade 2 follicular lymphoma, stage iv grade 3 follicular lymphoma, stage iv small lymphocytic lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cyclophosphamide, fludarabine phosphate, vincristine sulfate, prednisone
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, CC[C@]1(O)C[C@@H]2CN(C1)CCC1=C(NC3=CC=CC=C13)[C@@](C2)(C(=O)OC)C1=C(OC)C=C2N(C=O)[C@@H]3[C@]4(CCN5CC=C[C@](CC)([C@@H]45)[C@@H](OC(C)=O)[C@]3(O)C(=O)OC)C2=C1, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have Stage III-IV (Ann Arbor classification) low-grade Non-Hodgkin's
             lymphoma

          -  Baseline measurements and evaluations must be obtained within 4 weeks prior to
             registration; all areas of disease (evaluable and measurable) should be recorded and
             mapped out in order to assess response and uniformity of response to therapy; must
             have at least one objective MEASURABLE disease parameter

               -  Radiographic findings are acceptable providing that clear-cut measurement can be
                  made

               -  Abnormalities on scans may be used to document the presence of disease for
                  staging purposes; a clearly defined, bidimensionally measurable defect or mass
                  measuring at least 2 cm in diameter on a radionuclide or a CT scan will be
                  acceptable as measurable disease

               -  An enlarged spleen extending at least 2 cm below the costal margin will
                  constitute measurable disease providing that no explanation other than
                  lymphomatous involvement is likely; for an enlarged liver to constitute the only
                  evident measurable disease parameter, liver biopsy proof of lymphoma in the liver
                  is required

          -  Patients must have a tissue diagnosis of low-grade malignant lymphoma obtained within
             12 months prior to registration (according to the International Working Formulation)
             as below:

               -  ML- small lymphocytic (Category A)

               -  ML-follicular-small cleaved (Category B)

               -  ML-follicular-mixed small cleaved and large cell (Category C)

          -  Patients having both diffuse and follicular architectural elements will be considered
             eligible if the histology is predominantly follicular (i.e. >= 50% of the
             cross-sectional area); if the interval since tissue diagnosis of low-grade malignant
             lymphoma is > 12 months, diagnostic confirmation using either FNA or nodal biopsy is
             required to confirm that the histology remains in one of the eligible categories

          -  Women of child bearing potential and sexually active males are strongly advised to use
             an accepted and effective method of birth control

          -  No prior chemotherapy, radiotherapy, or immunotherapy

          -  No active, uncontrolled infections (afebrile for > 48 hours off antibiotics)

          -  No evidence of a previous or concurrent malignancy, with the exception of 1) treated
             carcinoma in situ of the cervix, 2) treated squamous cell or basal cell skin cancer OR
             3) any other surgically cured malignancy from which the patient has been disease free
             for at least 5 years

          -  ECOG performance status 0-1

          -  WBC > 3000/mm^3

          -  Plts > 100,000/mm^3

          -  Creatinine =< 1.5 mg/dl

          -  Bilirubin < 2.0 mg/dl

          -  LFTs =< 5x ULN (SGOT and Alkaline Phosphate)

          -  These lab values must be obtained within 4 weeks prior to protocol entry; patients
             with documented marrow involvement at the time of registration are not required to
             meet the hematologic parameters above

          -  Patient must give signed informed consent