Clinical trial NCT06608732: 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.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: B-cell Acute Lymphoblastic Leukemia
Keywords: Inaticabtagene autoleucel
autologous hematopoietic stem cell transplantation
Minimal Residual Disease
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
Collaborators: name: Juventas Cell Therapy Ltd.
First posted: 2024-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 \&amp;gt; 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.

Primary outcomes:
measure: Relapse-Free Survival
timeFrame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
Secondary outcomes:
measure: Overall survival rate
timeFrame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
measure: Cumulative recurrence rate
timeFrame: From autologous hematopoietic stem cell transplantation to 2 years after transplantation
measure: MRD negativity rate
timeFrame: 28 days after the first CAR-T cell reinfusion
Other outcomes:
Locations:
city: Tianjin
country: China
facility: National Institute of Hematology, Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
References: