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Trial Title:
Blinatumomab Maintenance After Allo-HSCT
NCT ID:
NCT06438796
Condition:
High Risk Acute Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Blinatumomab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Blinatumomab
Description:
Maintenance therapy with Blinatumomab initiation: 90 days to 120 days
post-transplantation
Arm group label:
Blinatumomab group
Summary:
To evaluate the safety and efficacy of Blinatumomab maintenance after allogeneic
hematopoietic stem cell transplantation for high-risk acute B-lymphoblastic leukemia.
Detailed description:
Blinatumomab is a novel immunological antibody based on BiTE. CD19 is a surface antigen
expressed throughout the development of B lymphocytes, making it an ideal target for
immunotherapy. Blinatumomab was approved by the FDA for the treatment of adults with
relapsed/refractory cancers. Open-label, single-arm, multicenter phase II clinical study
(BLAST study) , enrolling 116 adult patients with precursor B-ALL in complete hematologic
remission after at least 3 doses of intense chemotherapy but persistently positive for
Measurable Residual Disease (MRD) (MRD ≥10-3 ), which is the first ALL international
multicenter clinical trial. In August 2022, China's National Medicines and Pharmaceutical
Administration (NMPA) Approved Blinatumomab for the treatment of relapsed/refractory
precursor B-cell ALL in adults.
Blinatumomab is mostly used for preemptive therapy after post-transplant MRD conversion,
and fewer prospective studies have been conducted in the area of maintenance therapy. A
prospective single-arm clinical study (NCT02807883) with Blinatumomab as maintenance
therapy (up to 4 cycles) after allogeneic transplantation, concluded by MD Anderson in
August 2021, had the primary endpoints of safety (acute graft-versus-host disease [aGVHD]
and non-relapse mortality [NRM]) and the secondary endpoints of efficacy (PFS, OS, etc.),
a total of 23 patients were enrolled in patients who received at least 1 cycle of
Blinatumomab, the interval between transplantation and the first cycle of Blinatumomab
use was 78 days (44-105), 57% of the patients completed 4 cycles of treatment, the median
follow-up was 14.3 months, the 1-year NRM was 0%, the incidence of grade 3-4 aGVHD was
5%, the 1-year OS was 85%, and the 1-year PFS was 71%. There was a trend toward benefit
in PFS and OS curves between the two groups. Although this study is an exploratory study,
data from applied studies in the post-transplantation maintenance phase suggest that this
immunotherapy may be termed as a new, better and safer option.
Therefore, the investigators conducted a multicenter, randomized, controlled study based
on retrospective research to further explore and validate the safety and efficacy of
Blinatumomab as a maintenance therapy after high-risk B-ALL allogeneic transplantation.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 16-65 years
2. Diagnosis with acute B-lymphoblastic leukemia (B-ALL) expressed CD19
3. High-risk group B-ALL
4. Have suitable hematopoietic stem cell donors
5. No dysfunction of vital organs
Exclusion Criteria:
1. CR/MRD negative before blinatumomab maintenance
2. Active hepatitis B
3. HIV-infected
4. Active infections; acute and chronic GVHD requiring systemic immunosuppressive
therapy;
5. severe impairment of vital organ function
6. Those judged by the investigator to be unsuitable for participation in this trial.
Gender:
All
Minimum age:
16 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
July 1, 2024
Completion date:
July 1, 2028
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06438796
