Sign in

NCT02458014CompletedPhase 2

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

Phase II Study of Blinatumomab in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

This phase II trial studies how well blinatumomab works in treating patients with B-cell acute lymphoblastic leukemia whose disease is in remission (causes no symptoms or signs) but is still present in a small number of cells in the body (minimal residual disease). Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
37 (actual)
First submitted
26 May 2015
Start date
14 Sept 2015
Primary completion date
16 Sept 2025
Lead sponsor
M.D. Anderson Cancer Center
NCT number
NCT02458014

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 37
  • From 14 Sept 2015 to the primary completion date, 16 Sept 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Monoclonal antibodies therapy within 2 weeks before study entry
  • Radiotherapy and cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry

Other illness

  • Known to be human immunodeficiency virus positive (HIV+)
  • Active and uncontrolled disease/infection as judged by the treating physician
  • Active central nervous system (CNS) or extramedullary disease

Other

  • Pregnant or nursing women
  • Unable or unwilling to sign the consent form

Who the study is looking for

  • Patients with B-lineage acute lymphocytic leukemia (ALL) in hematologic complete remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity status before blinatumomab) or had a molecular relapse (i.e., became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy; molecular disease or minimal residual disease is defined by a value of at least of 1 x 10\^-4 (0.01%) by multicolor flow cytometry and/or by next generation sequencing (NGS)
  • Patients with B-lineage ALL in hematologic complete remission (CR) with molecular failure (i.e., had never achieved an MRD-negativity status before blinatumomab) or had a molecular relapse (i.e., became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy; molecular disease or minimal residual disease is defined by a value of at least of 1 x 10-4 (0.01%) by multicolor flow cytometry and/or by next generation sequencing (NGS)
  • Performance status of 0, 1, or 2
  • Creatinine clearance \>= 30 ml/minute
  • Bilirubin less than or equal to 3.0 mg/dL
  • No active or co-existing malignancy with life expectancy less than 12 months
  • Patients with Philadelphia chromosome positive (Ph+) ALL can be enrolled in CR1 or CR2 and beyond; a tyrosine kinase inhibitor (TKI) will be added at the discretion of the treating physician; MRD for these patients will be defined by PCR of 0.1% and above (International Scale)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.