Philadelphia Chromosome Negative ALLNCT06481241
Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL
A study testing CAR-T cells and Venetoclax in people with Philadelphia Chromosome Negative ALL and Acute Lymphoblastic Leukemia, Adult, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Chromosome Negative ALL, Acute Lymphoblastic Leukemia, Adult
- What is being tested?
- CAR-T cells and Venetoclax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2024to Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Male or female patients aged 18 years or older
- CD19 expression on blasts
- Expected survival time greater than 3 months
- 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%
- Subject has provided written informed consent prior to any screening procedure
Who cannot join
- Burkitt lymphoma/leukemia
- Acute Leukemia of Ambiguous Lineage
- Clinical manifestations of active CNS or extramedullary involvement with ALL
- Female patients who are pregnant or breast feeding
- Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
- Known HIV seropositivity
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- 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)
- Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
- Other conditions assessed by the investigators to be inappropriate for this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020
Jianxiang Wang, Dr., 86-22-23909120, wangjx@medmail.com.cn
Jianxiang Wang, Dr.
About this study
Official title: Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia
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.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.
Read the 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.
- Being tested
- CAR-T cells, Venetoclax
- Keywords
- Philadelphia Chromosome Negative Precursor B-Cell Acute Lymphoblastic Leukaemia, CAR-T cell, Venetoclax, Newly Diagnosed
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cellsCombination product
CAR-T cells as consolidation therapy
VenetoclaxDrug
Also called Selective inhibitor of B-cell lymphoma 2 (Bcl-2)
VEN
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy and Sequential CAR-T Cells | Experimental | Ph-ALL patients receiving CAR-T cells as consolidation therapy after achieving complete remission (CR) with pediatric-inspired regimen and venetoclax. Receives: Combination Product: CAR-T cells; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS)
From CR1 to relapse, death from any cause or last follow-up
Measured: Up to 2 years post-registration
Secondary outcomes (6)
MRD-negative complete remission rate measured by flow cytometry.
No blasts were detected by flow cytometry when CR criteria were met after induction therapy.
Measured: After induction (4 week)]
Overall survival (OS)
From the date of registration to the date of death resulting from any cause.
Measured: Up to 5 years post-registration
Event-free survival (EFS)
From the date of registration to the date of induction failure, relapse, death from any cause, or last follow-up
Measured: Up to 5 years post-registration
MRD-negative complete remission rate measured by NGS tracking clonal IG/TR rearrangements
No clonal IG/TR rearrangements were detected by NGS
Measured: Up to 1 year post-registration
Cumulative incidence of relapse (CIR)
Calculated with the cumulative incidence method, with death in patients who had a complete hematologic response as a competing risk.
Measured: Up to 2 years post-registration]
The rate of adverse events
adverse events during the treatment
Measured: Up to 5 years post-registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start10 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Philadelphia Chromosome Negative ALLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, Dr, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481241
- Sponsor's protocol ID
- IIT2024020
- Status last verified
- Feb 2026
- First submitted
- 24 May 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No