To hear about similar clinical trials, please enter your email below
Trial Title:
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL
NCT ID:
NCT06481241
Condition:
Philadelphia Chromosome Negative ALL
Acute Lymphoblastic Leukemia, Adult
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Venetoclax
Conditions: Keywords:
Philadelphia Chromosome Negative Precursor B-Cell Acute Lymphoblastic Leukaemia
CAR-T cell
Venetoclax
Newly Diagnosed
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
CAR-T cells
Description:
CAR-T cells as consolidation therapy
Arm group label:
Chemotherapy and Sequential CAR-T Cells
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
VEN
Arm group label:
Chemotherapy and Sequential CAR-T Cells
Other name:
Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
Summary:
In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has
demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL. The
available data suggest that the advancement of immunotherapy from relapsed/refractory
(R/R) field to the frontline setting may be an important approach to increase the depth
of remission, which ultimately translates into a survival benefit. In this study, the
investigators propose a treatment regimen using CAR-T cell therapy as a consolidation
method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming
to reduce the total cycles of chemotherapy and related toxicities, shorten length of
hospitalization, and ultimately improve patients' survival and quality of life.
Detailed description:
The CAR-T cells were murine-derived second-generation CD19 CAR-T with a co-stimulation
domain of 4-1BB, and the infusion dose was 1×10^6/kg CAR+ cells in a single infusion.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by
the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular
biology according to WHO classification
2. Male or female patients aged 18 years or older
3. CD19 expression on blasts
4. Expected survival time greater than 3 months
5. Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of
normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate
aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver
is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline
phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes:
Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound
ejection fraction ≥ 45%
6. Subject has provided written informed consent prior to any screening procedure
Exclusion Criteria:
1. Burkitt lymphoma/leukemia
2. Acute Leukemia of Ambiguous Lineage
3. Clinical manifestations of active CNS or extramedullary involvement with ALL
4. Female patients who are pregnant or breast feeding
5. Uncontrolled active serious infections that could, in the investigator's opinion,
potentially interfere with the completion of treatment
6. Known HIV seropositivity
7. Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal)
or sinus block, history of chronic bradycardia with a high degree of
atrioventricular (AV) conduction block (unless a permanent pacemaker is implanted)
8. Any serious psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment
9. Other conditions assessed by the investigators to be inappropriate for this study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Institute of Hematology & Blood Diseases Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Start date:
June 2024
Completion date:
June 2028
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06481241
