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| ID | Type | Description | Link |
|---|---|---|---|
| IIT2026063-EC-1 | Other Identifier | Ethics Committee of Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC |
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This is a prospective, open-label, single-arm, umbrella phase 2 clinical trial enrolling 32 adult patients with newly diagnosed Philadelphia chromosome-negative (Ph-) B-cell acute lymphoblastic leukemia (B-ALL). All patients receive a frontline treatment backbone consisting of low-dose chemotherapy combined with immuno-targeted agents and a BCL2 inhibitor. Subsequent treatment pathways are guided by MRD response, disease characteristics, and clinical decision-making, including antibody-based immunotherapy, CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients continue protocol-defined maintenance therapy after consolidation.
The primary endpoint is the complete remission rate with negative flow cytometric MRD after induction therapy. MRD is monitored longitudinally by flow cytometry, quantitative PCR, and immune repertoire sequencing. Safety is evaluated according to NCI CTCAE version 5.0.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuno-Targeted Therapy Plus Low-Dose Chemotherapy | Experimental | Adult patients with newly diagnosed Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (Ph- B-ALL) receive frontline treatment with immuno-targeted agents, a BCL2 inhibitor, and low-dose chemotherapy. Induction therapy includes inotuzumab ozogamicin, venetoclax, vincristine, cyclophosphamide, and dexamethasone. Subsequent treatment is adapted according to measurable residual disease (MRD) response, antigen expression profile, and clinical condition, and may include blinatumomab-based immunotherapy, venetoclax-containing chemotherapy, CD19-directed CAR-T cell therapy, or hematopoietic stem cell transplantation. All patients proceed to protocol-defined maintenance therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inotuzumab Ozogamicin (IO) | Drug | Anti-CD22 antibody-drug conjugate (ADC) administered intravenously during induction and consolidation therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Flow Cytometric MRD-Negative Complete Remission Rate | Proportion of patients achieving complete remission (CR) with negative measurable residual disease (MRD) assessed by multiparameter flow cytometry after completion of induction therapy. | At the end of induction therapy (approximately 1 month after treatment initiation) |
| Measure | Description | Time Frame |
|---|---|---|
| Next-Generation Sequencing (NGS)-MRD Negative Remission Rate | Proportion of patients achieving MRD-negative remission assessed by immune repertoire sequencing. | Within 3 months after treatment initiation |
| Best MRD Clearance Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Wang, MD, PhD | Contact | +86 22-23608095 | wangying1@ihcams.ac.cn |
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| Venetoclax | Drug | BCL-2 inhibitor administered orally daily during induction and consolidation cycles to enhance leukemic cell apoptosis. |
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| Blinatumomab | Drug | CD19/CD3 bispecific T-cell engager (BiTE) administered as continuous intravenous infusion during consolidation therapy. |
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| CD19-directed chimeric antigen receptor (CAR-T) T cells | Biological | Autologous CD19 CAR-T cell therapy administered as a single intravenous infusion as optional consolidation therapy for eligible patients. |
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| Vincristine | Drug | A vinca alkaloid that inhibits microtubule formation by binding to tubulin, resulting in mitotic arrest and inhibition of proliferation of rapidly dividing leukemic cells. |
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| Cyclophosphamide | Drug | An alkylating agent that forms DNA cross-links, leading to inhibition of DNA replication and transcription and subsequent apoptosis of rapidly proliferating hematopoietic cells. |
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| Dexamethasone | Drug | A synthetic glucocorticoid that induces lymphoid cell apoptosis and exerts anti-inflammatory and immunosuppressive effects, contributing to reduction of leukemic burden. |
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| Methotrexate | Drug | A folate antimetabolite that inhibits dihydrofolate reductase, resulting in impaired DNA synthesis and cell replication, particularly in rapidly dividing lymphoid cells. |
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| Cytarabine (Ara-C) | Drug | A pyrimidine nucleoside analog that inhibits DNA polymerase, leading to termination of DNA chain elongation and inhibition of leukemic cell proliferation. |
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| Prednisone | Drug | A glucocorticoid that induces apoptosis in lymphoid cells and provides anti-inflammatory and immunosuppressive effects as part of multi-agent leukemia therapy. |
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| Mercaptopurine 50 mg | Drug | A purine analog antimetabolite that interferes with purine nucleotide synthesis and incorporates into DNA and RNA, inhibiting nucleic acid synthesis and cell proliferation. |
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Proportion of patients achieving the deepest MRD response during the first 3 months of treatment as assessed by flow cytometry, quantitative PCR, or immune repertoire sequencing.
| Within 3 months after treatment initiation |
| Overall Survival (OS) | Time from study enrollment to death from any cause. | Up to 5 years |
| Disease-Free Survival (DFS) | Time from achievement of complete remission to relapse or death from any cause. | Up to 5 years |
| Relapse-Free Survival (RFS) | Time from achievement of MRD-negative remission to hematologic relapse or death. | Up to 5 years |
| 30-Day Mortality | Proportion of patients who die from any cause within 30 days after treatment initiation. | 30 days |
| 60-Day Mortality | Proportion of patients who die from any cause within 60 days after treatment initiation. | 60 days |
| Incidence of Adverse Events | Frequency, severity, and type of adverse events graded according to the National Cancer | From treatment initiation through completion of study treatment, up to 5 years |
| ID | Term |
|---|---|
| D000080045 | Inotuzumab Ozogamicin |
| C579720 | venetoclax |
| C510808 | blinatumomab |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D003907 | Dexamethasone |
| D008727 | Methotrexate |
| D003561 | Cytarabine |
| D011241 | Prednisone |
| D015122 | Mercaptopurine |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011244 | Pregnadienediols |
| D013438 | Sulfhydryl Compounds |
| D013457 | Sulfur Compounds |
| D011687 | Purines |
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