Clinical trial NCT00337194 (phase 2, status: completed)
Conditions: adult lymphocyte depletion hodgkin lymphoma, adult lymphocyte predominant hodgkin lymphoma, adult mixed cellularity hodgkin lymphoma, adult nodular sclerosis hodgkin lymphoma, recurrent adult hodgkin 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
Drugs: vinorelbine tartrate, pegylated liposomal doxorubicin hydrochloride, gemcitabine hydrochloride
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented CD30-positive classical Hodgkin lymphoma according to the
             World Health Organization (WHO) classification of lymphoid malignancies that is
             recurrent or refractory after at least one prior therapy

               -  Note: Patients with nodular lymphocyte predominant HL are not eligible; all other
                  subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte rich, and
                  mixed cellularity HL may be enrolled

               -  Core needle biopsies are acceptable if they contain adequate tissue for primary
                  diagnosis and immunophenotyping; bone marrow biopsies as the sole means of
                  diagnosis are not acceptable, but they may be submitted in conjunction with nodal
                  biopsies; fine needle aspirates are not acceptable; if the original diagnostic
                  specimen is not available, specimens obtained at relapse may be submitted; if
                  multiple specimens are available, please submit the most recent; failure to
                  submit pathology specimens within 60 days of patient registration will be
                  considered a major protocol violation

          -  Patients must have relapsed or refractory disease after at least one prior therapy,
             with at least a 3 week interval from the completion of the most recent chemotherapy or
             radiotherapy regimen; recovery to =< grade 1 from all toxicities related to the prior
             treatments is required; patients who have previously received a stem cell transplant
             are permitted to enroll on this study

               -  Prior treatment with an anti-CD30 antibody, gemcitabine, vinorelbine, or
                  pegylated liposomal doxorubicin is not permitted

          -  No uncontrolled angina, no myocardial infarction (MI) within 6 months of study entry,
             and no New York Heart Association (NYHA) class II or greater congestive heart failure
             (CHF)

          -  Baseline left ventricular ejection fraction (LVEF) by multi gated acquisition scan
             (MUGA) or echocardiogram (ECHO) must be >= 45%

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Measurable disease must be present on either physical examination or imaging studies;
             evaluable or non-measurable disease alone is not acceptable

               -  Measurable disease is defined as any lesion that can be accurately measured in at
                  least one dimension (longest diameter to be recorded) as >= 10 mm

               -  Non-measurable disease includes all other lesions, including small lesions (< 10
                  mm) and truly non-measurable lesions

               -  Lesions that are considered non-measurable include the following:

                    -  Bone lesions (lesions, if present, should be noted)

                    -  Bone marrow involvement (if present, this should be noted)

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Lymphangitis cutis/pulmonis

          -  Pregnant or nursing women may not be enrolled; women of childbearing potential must
             have a negative serum or urine pregnancy test prior to registration; women and men of
             reproductive potential should agree to use an effective means of birth control

          -  Corrected diffusion capacity of carbon monoxide (DLCO) >= 50%

          -  Absolute neutrophil count (ANC) >= 1,200/uL

          -  Platelet count >= 100,000/uL

          -  Creatinine =< 2.0 mg/dL

          -  Bilirubin =< 2.0 mg/dL

               -  Absent a history of Gilbert's disease

          -  Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal