A Randomized Phase II Trial of Brentuximab Vedotin (SGN35 NSC# 749710) or Crizotinib (NSC#749005 Commercially Labeled) in Combination With Chemotherapy for Newly Diagnosed Patients With Anaplastic Large Cell Lymphoma (ALCL)
Sandeep Batra, MD
Primary Investigator
Brief description of study
This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma.
Detailed description of study
The purpose of this study is to determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (anaplastic large cell lymphoma [ALCL]99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99); and to estimate the event free survival (EFS) of Arm brentuximab vedotin (BV) and Arm crizotinib (CZ) and contrast these to historical control data.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Anaplastic Large Cell Lymphoma
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Age: - 21 Years
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Gender: All
Inclusion Criteria
Newly diagnosed patients with histologically proven ALCL
Disease must be cluster of differentiation (CD)30 positive
Disease must be anaplastic lymphoma kinase (ALK) positive
Patients must have stage II, III, or IV disease
Patients must have a life expectancy of >= 8 weeks
Exclusion Criteria
Patients with central nervous system (CNS) disease
Patients with disease limited to the skin are not eligible, regardless of how wide-spread
Patients with stage I disease
Patients who have received any prior cytotoxic chemotherapy for the current diagnosis of ALCL or any cancer diagnosed previously
Previous steroid treatment and/or radiation treatment is not allowed unless it is for the emergent management of a mediastinal mass; emergent steroid treatment and/or radiation treatment should stop once protocol therapy is initiated
Intrathecal chemotherapy prior to enrollment is allowed for the current diagnosis of ALCL as long as adequate cerebrospinal fluid (CSF) is obtained prior to administration of the intrathecal chemotherapy and subsequently demonstrated to be negative for ALCL
Female patients who are pregnant
Lactating females are not eligible unless they have agreed not to breastfeed their infants
Sexually active patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of treatment and for 3 months after stopping treatment
Patients with Down syndrome
Patients with an immunodeficiency that existed prior to diagnosis such as primary immunodeficiency syndromes or organ transplant recipients
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