Overview

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

Status:
Recruiting
Trial end date:
0000-00-00
Target enrollment:
40
Participant gender:
Both
Summary
The goal of this clinical research study is to learn if Blinacyto (blinatumomab) can help to control ALL with positive MRD. The safety of this drug will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Antibodies, Bispecific
Blinatumomab
Last Updated:
2016-08-15
Criteria
Inclusion Criteria:

1. Patients at least 18 years of age.

2. Patients with B-lineage ALL in hematologic complete remission (CR) with molecular
failure (ie, had never achieved an MRD-negativity status before blinatumomab) or had
a molecular relapse (ie, 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 1x10^-4 by multicolor flow
cytometry.

3. Patients with B-lineage ALL in CR2 and beyond with molecular failure at any time
point after 2 months of salvage therapy are allowed, including patients who received
prior allogeneic stem cell transplantation.

4. Performance status of 0, 1, or 2

5. Adequate organ function with creatinine clearance >/= 30 ml/minute and bilirubin less
than or equal to 3.0 mg/dL.

6. No active or co-existing malignancy with life expectancy less than 12 months.

Exclusion Criteria:

1. Pregnant or nursing women

2. Known to be HIV+

3. Ph+ ALL

4. Active and uncontrolled disease/infection as judged by the treating physician

5. Unable or unwilling to sign the consent form

6. Active CNS or extramedullary disease

7. Monoclonal antibodies therapy within 2 weeks before study entry

8. 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