A RANDOMIZED PHASE III STUDY OF BENDAMUSTINE PLUS RITUXIMAB VERSUS IBRUTINIB PLUS RITUXIMAB VERSUS IBRUTINIB ALONE IN UNTREATED OLDER PATIENTS (≥ 65 YEARS OF AGE) WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Date Added
April 4th, 2014
PRO Number
Pro00033691
Researcher
Brian Hess

List of Studies


Keywords
Cancer/Leukemia
Summary

This study is for male and female patients who are 65 years of age or older who have chronic lymphocytic leukemia (CLL) that has never been treated before, and their disease has progressed to the point that therapy has been recommended. The purpose of this study is to compare the effects, good and/or bad, of the drug ibrutinib, either alone or in combination with the drug rituximab, with the standard treatment for this disease. The standard treatment is chemotherapy with the drug bendamustine in combination with the drug rituximab. The effects on the patient and their leukemia will be looked at to find out which treatment is better. Both bendamustine and rituximab are approved by the FDA to treat chronic lymphocytic leukemia (your leukemia type), but ibrutinib is considered investigational. In this study, patients will get either the drug ibrutinib alone, or ibrutinib with rituximab, or bendamustine with rituximab. If the patient is in the group that receives bendamustine with rituximab and their disease returns, they will have the option to receive ibrutinib.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (IND#73789, NSC#732517) in Patients with Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

Date Added
June 22nd, 2012
PRO Number
Pro00016822
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

To collect information about the patient's leukemia and to seek the optimal treatment for children with ALL based on the individual level of risk of the cancer coming back after treatment. The risk groups are defined as a result of recent research conducted by the Children's Oncology Group (COG). We would like to learn if the use of an experimental intrathecal therapy (ITT), which has been given to many people with ALL and has been well tolerated, would be better at preventing relapse in the central nervous system and improve disease outcomes in children with High Risk ALL.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu



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