Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease

Phase 2

Active, not recruiting

• Conditions: Adult Acute Lymphoblastic Leukemia in Complete Remission; B Acute Lymphoblastic Leukemia; Minimal Residual Disease; Philadelphia Chromosome Positive

• Registration Number: NCT02458014
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-5-26
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients with B-lineage acute lymphocytic leukemia (ALL) in hematologic complete<br> remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity<br> status before blinatumomab) or had a molecular relapse (i.e., became MRD positive<br> after having been MRD negative) starting at any time point after 3 months of<br> frontline therapy; molecular disease or minimal residual disease is defined by a<br> value of at least of 1 x 10^-4 (0.01%) by multicolor flow cytometry and/or by next<br> generation sequencing (NGS)<br><br> - Patients with B-lineage ALL in hematologic complete remission (CR) with molecular<br> failure (i.e., had never achieved an MRD-negativity status before blinatumomab) or<br> had a molecular relapse (i.e., became MRD positive after having been MRD negative)<br> starting at any time point after 3 months of frontline therapy; molecular disease or<br> minimal residual disease is defined by a value of at least of 1 x 10-4 (0.01%) by<br> multicolor flow cytometry and/or by next generation sequencing (NGS)<br><br> - Performance status of 0, 1, or 2<br><br> - Creatinine clearance >= 30 ml/minute<br><br> - Bilirubin less than or equal to 3.0 mg/dL<br><br> - No active or co-existing malignancy with life expectancy less than 12 months<br><br> - Patients with Philadelphia chromosome positive (Ph+) ALL can be enrolled in CR1 or<br> CR2 and beyond; a tyrosine kinase inhibitor (TKI) will be added at the discretion of<br> the treating physician; MRD for these patients will be defined by PCR of 0.1% and<br> above (International Scale)<br><br>Exclusion Criteria:<br><br> - Pregnant or nursing women<br><br> - Known to be human immunodeficiency virus positive (HIV+)<br><br> - Active and uncontrolled disease/infection as judged by the treating physician<br><br> - Unable or unwilling to sign the consent form<br><br> - Active central nervous system (CNS) or extramedullary disease<br><br> - Monoclonal antibodies therapy within 2 weeks before study entry<br><br> - Radiotherapy and cancer chemotherapy (except for intrathecal prophylaxis and/or<br> low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate,<br> steroids) or any investigational drug within 2 weeks before study entry

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse-free survival (RFS)

Secondary Outcome Measures

Name	Time	Method
Event-free survival;Overall survival (OS);MRD negativity rate;MRD negativity rate after course 1;Incidence of toxicity