Blinatumomab after Donor Stem Cell Transplant in Treating Patients with Acute Lymphoblastic Leukemia
- Patients with B-lineage ALL in a) hematologic complete remission (CR) beyond CR1 at time of transplant; patients beyond CR1 or with primary induction failure may be without minimal residual disease, b) any residual disease defined by positive flow > 0.01%, detection of breakpoint cluster region-abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) transcript by polymerase chain reaction (PCR) with a sensitivity of 1/10,000, or detection of the t(9;22) translocation in any metaphases by cytogenetics at time of transplant, or presence of the MLL gene
- Received an allogeneic HCT within the last 100 days; enrollment within 30-100 days after transplant, and after adequate recovery of counts
- Absolute neutrophil count (ANC) >= 0.5 x 10^9/L without daily use of myeloid growth factor
- Platelet > 20 x 10^9/L without platelet transfusion within 1 week
- Creatinine clearance greater than 30 ml/min (or greater than 60 ml/min/1.73)
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) < 5 x upper limit of normal (ULN)
- Serum bilirubin < 3 x ULN
- Performance status of 0, 1, or 2; Karnofsky (or Lansky for subjects < 16 years old) performance status >= 50
- Relapsed ALL defined as > 5% malignant blasts in bone marrow or peripheral blood
- Active GVHD requiring systemic steroid therapy; medications for GVHD prophylaxis are acceptable
- Systemic steroid therapy unless for physiologic replacement
- Uncontrolled disease/infection as judged by the treating physician
- Active ALL in the central nervous system (CNS), as defined by >= 5 leukocytes per microL with identifiable blast cells in the cerebrospinal fluid (CSF), and/or the presence of cranial-nerve palsies
- Pregnant or nursing women
I. To assess the feasibility of blinatumomab post allogeneic hematopoietic cell transplantation (HCT) as consolidation therapy in patients with B-lineage acute lymphoblastic leukemia (ALL).
I. To evaluate the progression-free survival (PFS) rate at 1-year for patients with ALL compared to
contemporary patient cohort.
II. To evaluate other efficacy endpoints such as overall survival (OS) and minimal residual disease
(MRD) negativity rate in patients treated with blinatumomab for consolidation therapy.
III. To evaluate, non-relapse mortality (NRM) and chronic graft-versus-host-disease (GVHD).
Patients receive blinatumomab intravenously (IV) continuously over weeks 1-4. Treatment repeats every 6 weeks for up to 4 courses at 3, 6, 9, and 12 months following HCT.
After completion of study treatment, patients are followed up at 2 weeks.
Trial Phase Phase II
Trial Type Treatment
M D Anderson Cancer Center
- Primary ID 2015-0576
- Secondary IDs NCI-2016-01182
- Clinicaltrials.gov ID NCT02807883