- Gender
- Minimum Age
- Maximum Age
- Physicians
- Pauly, Melinda
- Phases
- II
- Drugs
- N/A
- Disease Sites
- Non-Hodgkin's Lymphoma
- Locations
- Winship Cancer Institute
- NCT ID
- NCT01979536
- Protocol Number
- IRB00072174
- Contact
- If interested in learning more about this clinical trial, please contact winshipcto@emory.edu or (404) 778-1868.
Title
ANHL12P1: 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)
Summary
Primary Objectives:
-to determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (ALCL99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99)
to estimate the event free survival (EFS) of Arm BV and Arm CZ and contrast these to historical control data
Secondary Objectives:
-to determine the prognastic significance of minimal disseminated disease (MDD) at diagnosis and minimal residual disease (MRD)
Detail
Primary Objectives:
-to determine the tolerability of brentuximab vedotin given in combination with standard chemotherapy (ALCL99) and to determine the tolerability of crizotinib given in combination with chemotherapy (ALCL99)
to estimate the event free survival (EFS) of Arm BV and Arm CZ and contrast these to historical control data
Secondary Objectives:
-to determine the prognastic significance of minimal disseminated disease (MDD) at diagnosis and minimal residual disease (MRD)