Actively Recruiting
Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-11-05
20
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
J
Juventas Cell Therapy Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.
CONDITIONS
Official Title
Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG score of 0 to 1
- Newly diagnosed Ph-negative B-ALL within 6 months, achieving CR1 after standard induction chemotherapy, undergoing at least one consolidation therapy, and bone marrow MRD 0.01% detected by routine flow cytometry
- Newly diagnosed Ph-positive B-ALL within 6 months, achieving CR1 after guideline-recommended induction chemotherapy (or TKI use), undergoing at least one consolidation therapy, and BCR-ABL1 > 0% detected by routine q-PCR
- No significant organ dysfunction
- Willing and meet conditions for autologous hematopoietic stem cell transplantation
You will not qualify if you...
- Burkitt lymphoma/leukemia, heterozygous or double-expressor leukemia, or chronic myeloid leukemia in blast phase
- Bone marrow or peripheral blood blasts 5% before screening or pre-treatment, or extramedullary leukemia
- Prior CAR-T cell therapy or hematopoietic stem cell transplantation before screening or pre-treatment
- Genetic syndromes related to bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known bone marrow failure syndromes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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