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)
Investigating Treatments for Anaplastic Large Cell Lymphoma (ALCL)
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 (ALCL),Anaplastic Large Cell Lymphoma,ALCL,Large Cell Lymphoma,Large Cell,Lymphoma,Cancer,Oncology,Pediatric,Kid,Kids,Teen,Teens,Teenager,Teenagers,Child,Children,Adolescent,Youth
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Age: 21 years or below
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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
This study investigates how well different treatments work for patients with a type of cancer called anaplastic large cell lymphoma (ALCL). ALCL is a cancer that affects the lymph nodes and is characterized by certain markers on the cancer cells, like CD30 and ALK. The study is testing two treatment arms: one uses an investigational medication combined with standard chemotherapy, and the other uses a different investigational medication with chemotherapy. The goal is to see how well these treatments work and how patients tolerate them.
Participants in the study will receive either the investigational medication brentuximab vedotin or crizotinib, each combined with chemotherapy. The study will monitor how patients respond to these treatments and any side effects they experience. Brentuximab vedotin and crizotinib are investigational medications, which means they are not yet approved for general use. The study will compare the results to past data to see if these new combinations improve patient outcomes.
- Who can participate: This study is for patients newly diagnosed with ALCL, a type of lymphoma, who have stage II, III, or IV disease that is CD30 and ALK positive, with a life expectancy of at least 8 weeks.
- Study details: Participants will be assigned to one of two treatment arms and will receive either brentuximab vedotin or crizotinib along with chemotherapy. Brentuximab vedotin and crizotinib are investigational medications, meaning they are not yet approved for general use. Participants will not receive any payment for their involvement in the study.
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