SGN-30 and Combination Chemotherapy in Treating Patients With Newly Diagnosed Anaplastic Large Cell Lymphoma

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