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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Inaticabtagene autoleucel.
- Who it may be relevant to
- Registry conditions: B-cell Acute Lymphoblastic Leukemia. Basic parameters: 16 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study of Inaticabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.
Overview
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.
Detailed description
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.
Interventions
- Biological Inaticabtagene autoleucel
CNCT19 combined with autologous hematopoietic stem cell transplantation，Dose: （0.5 -2）x 10\^6/kg CNCT19 Cell Injection via intravenous infusion.
Primary outcome measures
- Relapse-Free Survival [Time frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
Secondary outcome measures (3)
- Overall survival rate [Time frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
- Cumulative recurrence rate [Time frame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation]
- MRD negativity rate [Time frame: 28 days after the first CAR-T cell reinfusion]
Eligibility criteria
Inclusion criteria
- 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 patients with bone marrow MRD ≥ 0.01% detected by routine flow cytometry.
- Or newly diagnosed Ph-positive B-ALL within 6 months, achieving CR1 after guideline-recommended induction chemotherapy (or use of TKI), undergoing at least one consolidation therapy, and patients with BCR-ABL1 \> 0% detected by routine q-PCR technology.
- No significant organ dysfunction
- Willing and meet the conditions for autologous hematopoietic stem cell transplantation
Exclusion criteria
- Burkitt lymphoma/leukemia, heterozygous or double-expressor leukemia, or chronic myeloid leukemia in blast phase.
- Before screening or pre-treatment, bone marrow or peripheral blood with blasts ≥ 5%; or extramedullary leukemia.
- Individuals who have received CAR-T cell therapy before screening or pre-treatment; or patients who have undergone hematopoietic stem cell transplantation.
- Patients with associated genetic syndromes related to bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- National Institute of Hematology, Chinese Academy of Medical Sciences — Tianjin
Identifiers
NCT: NCT06608732 · IIT2024037