Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)
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- STATUS
- Recruiting
Summary
This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed).
Description
The purpose of this study is to compare disease free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapse B-cell acute lymphoblastic leukemia (B-ALL) patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR randomization), and to compare the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 2 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR randomization).
FAQ
Details
| Condition | Relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL),Relapsed B-cell Acute Lymphoblastic Leukemia,B-ALL,relapsed,acute lymphoblastic leukemia,lymphoblastic leukemia,leukemia,lymphoblastic,cancer,oncology,childhood,child,children,kid,kids,teen,teens,teenager,teenagers,adolescent,youth,riley |
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| Age | 1years - 30years |
| Clinical Study Identifier | TX4663 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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