Blinatumomab as Maintenance Therapy in Patients With High-risk B-lineage Acute Lymphoblastic Leukemia Post Allogeneic Hematopoietic Cell Transplantation

ConditionB-ALL
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

Patients ≥ 14 years of age after B-ALL allogeneic transplantation received 4 cycles of maintenance therapy with blinatumomab +/- TKI and were followed for more than 1 year to assess overall survival (OS), relapse-free survival (RFS), incidence of acute and chronic GVHD, safety, etc.

Eligibility criteria

Qualifiers

1.Age ≥ 14 years, male or female; 2.CD19 + acute B lymphoblastic leukemia treated with allogeneic hematopoietic stem cell transplantation [Patients, the types of transplantation include fully matched sibling transplantation, haploidentical related donor transplantation and unrelated donor transplantation; 3.CD19 + acute B-lymphoblastic leukemia at risk of relapse before transplantation [including but not limited to: refractory leukemia: failure to achieve complete remission (CR)/CR with partial hematological recovery (CRh)/CR with incomplete hematological recovery (CRi) or CR/CRh/CRi after the end of induction therapy (generally refers to 4-week regimen or Hyper-CVAD regimen), but still positive for measurable residual disease (MRD); relapsed leukemia: patients who have achieved CR have blasts in peripheral blood or bone marrow (proportion > 5%), or extramedullary disease; onset of white blood cells > 30 × 109/L; patients with poor prognosis cytogenetic abnormalities; patients with positive residual leukemia before transplantation, etc.] 4.The disease is in complete remission, and residual leukemia is negative, absolute neutrophil count ≥ 1.0 × 109/L, platelet count ≥ 50 × 109/L, lasting for more than a week; 5.Freedom from ≥ Grade 3 acute GVHD or uncontrolled moderate to severe chronic GVHD within 30 days prior to enrollment; Awareness and willingness to sign written informed consent.

Disqualifiers

1.Patients with hematological relapse or minimal residual disease relapse of B-ALL after transplantation; 2.Presence of serious uncontrolled active infection (e.g., sepsis, pulmonary infection, etc.).

Trial design

Treatments tested in this trial

  • Blinatumomab

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations