Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

Overview

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).

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions: acute lymphoblastic leukemia
  • Age: Between 1 Years - 30 Years
  • Gender: Male or Female

Inclusion Criteria
First relapse of B-ALL with or without extramedullary disease
No waiting period for patients who relapse while receiving standard maintenance therapy
Patients who relapse on frontline therapy in phases other than maintenance must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
Patient has not had prior treatment with blinatumomab
Exclusion Criteria
Patients with Philadelphia chromosome positive/breakpoint cluster region protein (BCR)-Abelson murine leukemia viral oncogene homolog 1 (ABL1)+ ALL
Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL)
Patients with B-lymphoblastic lymphoma (B-LL)
Patients with known optic nerve and/or retinal involvement
Patients known to have one of the following concomitant genetic syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
Patients with known human immunodeficiency virus (HIV) infection
Patients with known allergy to mitoxantrone, cytarabine, or both etoposide and etoposide phosphate (Etopophos)
Lactating females who plan to breastfeed
Patients who are pregnant
PatiexpressionDISABLEDpatients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved)
Patients with uncontrolled seizure disorder


Additional Information:
Participants will not be paid for their participation.

Updated on 30 Nov 2022 . Study ID: TX4663

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