Clinical trial NCT06658938: Blinatumomab as Maintenance Therapy in Patients With High-risk B-lineage Acute Lymphoblastic Leukemia Post Allogeneic Hematopoietic Cell Transplantation
Official title: A Prospective, Single-arm Clinical Study of Blinatumomab in the Maintenance Treatment of High-risk Patients With Acute B-lymphoblastic Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: B-ALL
Keywords: allogeneic hematopoietic stem cell transplantation
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Beginning 3 months after transplantation, 1 cycle of blinatumomab was performed every 3 months for a total of 4 maintenance cycles.

Dosage of blinatumomab: 9 ug/d D1-4, 28 ug/d D5-14

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.).

  3.Markedly abnormal screening laboratory tests: A) Alanine aminotransferase (ALT) ≥ 5 × ULN (upper limit of normal); B) Aspartate aminotransferase (AST) ≥ 5 × ULN; C) Total bilirubin (TBIL) ≥ 3 × ULN; D) Creatinine clearance \< 70 mL/min at screening; Patients with active hepatitis B (hepatitis B surface antigen positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1 × 102 copies/mL); F) Hepatitis C antibody positive; G) Human immunodeficiency virus (HIV) positive; h) Treponema pallidum antibody positive; 4.ECOG performance status ≥ 3 5.Estimated survival less than 3 months This study may not be completed for other reasons, or the investigator considers it inappropriate to participate in this study.

Primary outcomes:
measure: CIR)
timeFrame: 2 years
Secondary outcomes:
measure: OS
timeFrame: 2 years
measure: RFS
timeFrame: 2 years
measure: incidence of acute and chronic GVHD
timeFrame: 1-year
Other outcomes:
Locations:
Study officials:
References: