Clinical trial NCT01851551 (phase 1/phase 2, status: completed)
Conditions: non-hodgkin's lymphoma, diffuse large b-cell lymphoma, mantle cell 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
Drugs: vincristine sulfate liposome injection plus rituximab
SMILES: 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
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically-confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL), as defined
             by the Revised European American Lymphoma/WHO classification. This included: diffuse
             large B-cell, primary mediastinal large B-cell lymphoma with sclerosis,intravascular
             large B-cell lymphoma, immunoblastic B-cell lymphoma, T-cell rich B-cell lymphoma or
             anaplastic large B-cell lymphoma. In the US protocol only, patients who had
             transformation from an indolent lymphoma and those who had mantle cell lymphoma were
             eligible.

               -  Confirmation of CD20 expression on lymphoma cells.

               -  Eastern Cooperative Oncology Group (ECOG) ≤2.

               -  One or more prior chemotherapy regimens. Patients who had received prior
                  rituximab therapy as part of an induction chemotherapy regimen or who had a
                  previous response to rituximab as a single agent were eligible.

               -  Measurable disease in at least 1 site, which had not been previously irradiated.

        Measurable disease was defined as at least 1 bidimensionally measurable lesion with clearly
        defined margins that were ≥1.5 cm in the largest dimension determined by physical
        examination or computed tomography (CT) scan.

          -  Total bilirubin and serum creatinine ≤2 times the ULN.

          -  Absolute neutrophil count (ANC) ≥0.5 × 109/L, and platelets ≥50 × 109/L.

          -  18 years of age or older.

          -  Women of childbearing potential who were willing to use an acceptable method of
             contraception throughout the course of the study.

        Signed and dated informed consent form.

        Exclusion Criteria:

          -  Known transformation from an indolent lymphoma (UK protocol only).

          -  Eligible for conventional or high-dose chemotherapy with curative intent.

          -  Radiotherapy, chemotherapy, immunotherapy, or corticosteroids (>10 mg/day of
             prednisone or equivalent) within the past 4 weeks.

          -  Any previous malignancies with less than a 5-year complete remission interval, except
             for curatively resected basal cell carcinoma or curatively resected in situ carcinoma
             of the uterine cervix.

          -  History of or active CNS-lymphoma, AIDS-related lymphoma, or any uncontrolled severe
             medical illness or infection.

          -  History of neurologic disorders unrelated to chemotherapy (including familial
             neurologic diseases and acquired demyelinating disorders).

          -  Grade 3 or 4 sensory or motor neuropathy at screening related to prior chemotherapy.

          -  Major surgery (excluding that for diagnosis) within 4 weeks of enrollment.

          -  Pregnant or lactating women (women of childbearing potential underwent a pregnancy
             test).

          -  Allergy to vincristine, or other vinca alkaloids.

          -  Progressive disease while receiving or within 1 month of having received previous
             rituximab therapy (US protocol only).

          -  Hypersensitivity to any component of rituximab or to murine proteins (UK protocol
             only).