Clinical trial NCT00365274 (phase 2, status: terminated)
Conditions: anaplastic large cell lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, sgn-30
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, 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, 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:

          -  Histologically or cytologically confirmed systemic anaplastic large cell lymphoma
             (ALCL)

          -  Tissue available for the determination of anaplastic large cell kinase (ALK) status
             [t(2;5), ALK-NPM translocation] prior to study entry

          -  Prior steroids or topical treatments are allowed. Patients who are on chronic steroid
             therapy may receive concomitant steroids provided they have been on a stable dosage
             for at least 3 months prior to enrollment

          -  Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1
             dimension (longest diameter to be recorded) as >= 20 mm by conventional techniques or
             as >= 10 mm by spiral CT scan

          -  The Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky
             PS 70-100%

          -  White Blood Count (WBC) >= 3,000/mm³

          -  Absolute neutrophil count >= 1,500/mm³

          -  Platelet count >= 100,000/mm³ (unless due to lymphoma [i.e., splenomegaly and/or bone
             marrow involvement])

          -  Bilirubin =< 1.5 times upper limit of normal (ULN)

          -  AST or ALT =< 2.5 times ULN

          -  Creatinine =< 1.5 times ULN (unless due to lymphoma) OR creatinine clearance >=60
             mL/min

          -  Left ventricular ejection fraction (LVEF) >= 50%

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

        Exclusion Criteria:

          -  No rapidly progressing disease or bulky disease, defined as a mass of > 7 cm in
             largest diameter

          -  No primary cutaneous ALCL

          -  No known brain metastases

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biological composition to monoclonal antibody SGN-30

          -  No uncontrolled intercurrent illness, including, but not limited to, any of the
             following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness or social situations that would preclude study compliance

          -  No prior or other concurrent malignancy with < 90% probability of survival at 5 years

          -  No other concurrent anticancer agents or therapies

          -  No prior chemotherapy for ALCL

          -  No other concurrent investigational agents