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    DRUG:

    Blincyto (blinatumomab)

    i
    Other names: MEDI 538, MT 103, MT103, AMG-103, MEDI-538, MT-103, AMG 103
    Company:
    Amgen, Astellas, BeiGene
    Drug class:
    CD3 agonist, CD19 inhibitor
    Related drugs:
    1d
    Efficacy and Safety of Low-dose Chemotherapy Plus Immuno-targeted Drugs in Newly Diagnosed Elderly/Unfit Ph- B-ALL (clinicaltrials.gov)
    P2, N=53, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
    New P2 trial
    |
    Venclexta (venetoclax) • cytarabine • cyclophosphamide • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • vincristine • prednisone • mercaptopurine
    2d
    Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (clinicaltrials.gov)
    P2, N=171, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date • Combination therapy
    |
    MCL1 (Myeloid cell leukemia 1) • KMT2A (Lysine Methyltransferase 2A) • BCL2L1 (BCL2-like 1)
    |
    BCL2 expression
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Rylaze (recombinant Erwinia asparaginase) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    2d
    A Study Comparing the Combination of Dasatinib and Chemotherapy Treatment With or Without Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or Philadelphia Chromosome-Like (Ph-Like) ABL-Class B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov)
    P3; Initiation date: Apr 2024 --> Jul 2024
    Trial initiation date
    |
    TruSight RNA Pan-Cancer Panel
    |
    dasatinib • imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Starasid (cytarabine ocfosfate)
    6d
    Disrupting B and T cell Collaboration in Autoimmune Disease: T cell engagers versus CAR T cell therapy? (PubMed, Clin Exp Immunol)
    Historically, B and T cell (B-T cell) co-interaction was targeted through different pathways such as alemtuzumab, abatacept, and dapirolizumab with variable impact on B cell depletion (BCD), whereas the majority of patients with AID including rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis and organ transplantation benefit from targeted BCD with anti-CD20 monoclonal antibodies such as rituximab, ocrelizumab or ofatumumab...In the treatment of cancer, chimeric antigen receptor (CAR) T cell therapy and T cell engagers (TCE) that recruit T cells to induce B cell cytotoxicity have delivered promising results for anti-CD19 CAR T cell therapies, the CD19 TCE blinatumomab and CD20 TCE such as mosunetuzumab, glofitamab or epcoritamab. Limited evidence suggests that anti-CD19 CAR T cell therapy may be effective in managing refractory AID whereas we await evaluation of TCE for use in non-oncological indications. Therefore, here, we discuss the potential mechanistic advantages of novel therapies that rely on T cells as effector cells to disrupt B-T cell collaboration toward overcoming rituximab-resistant AID.
    Journal • CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule) • CD27 (CD27 Molecule)
    |
    CD19 expression
    |
    Rituxan (rituximab) • Blincyto (blinatumomab) • Epkinly (epcoritamab-bysp) • Lunsumio (mosunetuzumab-axgb) • Columvi (glofitamab-gxbm) • Ocrevus (ocrelizumab)
    15d
    Golden Gate Study: Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P3, N=287, Recruiting, Amgen | Trial completion date: Sep 2031 --> Jan 2032 | Trial primary completion date: Dec 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    Blincyto (blinatumomab)
    16d
    A review of immunotargeted therapy for Philadelphia chromosome positive acute lymphoblastic leukaemia: making progress in chemotherapy-free regimens. (PubMed, Hematology)
    Since 2000, targeted therapy combined with chemotherapy, represented by the tyrosine kinase inhibitor Imatinib, has become the first-line treatment for PH + ALL...More recently, some innovative immune-targeted therapy greatly improved the prognosis of PH + ALL, such as Blinatumomab and Inotuzumab Ozogamicin...These new therapeutic interventions are changing the treatment landscape for PH + ALL. In summary, this review discusses the current advancements in targeted therapeutic agents shift in the treatment strategy of PH + ALL towards using more tolerable chemotherapy-free induction and consolidation regimens confers better disease outcomes and might obviate the need for HSCT.
    Review • Journal • IO biomarker
    |
    ABL1 (ABL proto-oncogene 1)
    |
    imatinib • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    19d
    Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL (clinicaltrials.gov)
    P1, N=17, Completed, Amgen | Phase classification: P1b --> P1
    Phase classification • Combination therapy
    |
    Blincyto (blinatumomab) • dexamethasone injection • zeluvalimab (AMG 404)
    22d
    Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia (clinicaltrials.gov)
    P3, N=160, Recruiting, Princess Maxima Center for Pediatric Oncology | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    KMT2A rearrangement • MLL rearrangement
    |
    Blincyto (blinatumomab)
    23d
    Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Mar 2024 --> Mar 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    BCR-ABL1 fusion
    |
    dasatinib • Blincyto (blinatumomab) • hydroxyurea
    23d
    Blina-CELL: Blinatumomab Followed by High-dose Chemotherapy for Ph-negative Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov)
    P2, N=27, Completed, Institute of Hematology and Blood Transfusion, Czech Republic | Active, not recruiting --> Completed | N=45 --> 27 | Trial completion date: Jul 2024 --> Feb 2024
    Trial completion • Enrollment change • Trial completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Blincyto (blinatumomab)
    23d
    Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL (clinicaltrials.gov)
    P2, N=35, Completed, Chen Suning | Active, not recruiting --> Completed
    Trial completion
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    cytarabine • Blincyto (blinatumomab)
    29d
    Observational Study of Blinatumomab (clinicaltrials.gov)
    P=N/A, N=279, Completed, Amgen | Active, not recruiting --> Completed
    Trial completion
    |
    Blincyto (blinatumomab)
    1m
    A Study Of Blinatumomab For The Treatment Of Relapsed Or Refractory Indolent Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P2, N=13, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed
    Trial completion
    |
    Blincyto (blinatumomab)
    1m
    Palbociclib and chemotherapy followed by blinatumomab consolidation to CAR-T cell therapy in KMT2A-rearranged, therapy-related acute lymphoblastic leukemia. (PubMed, Pediatr Blood Cancer)
    No abstract available
    Journal • CAR T-Cell Therapy
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    MLL rearrangement
    |
    Ibrance (palbociclib) • Blincyto (blinatumomab)
    1m
    A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients (clinicaltrials.gov)
    P1/2, N=125, Recruiting, Amgen | Trial completion date: Mar 2029 --> Sep 2028 | Trial primary completion date: Jun 2027 --> Nov 2026
    Trial completion date • Trial primary completion date
    |
    Blincyto (blinatumomab)
    1m
    Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (clinicaltrials.gov)
    P2, N=171, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial • Combination therapy
    |
    MCL1 (Myeloid cell leukemia 1) • KMT2A (Lysine Methyltransferase 2A) • BCL2L1 (BCL2-like 1)
    |
    BCL2 expression
    |
    Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Rylaze (recombinant Erwinia asparaginase) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate)
    1m
    Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL (clinicaltrials.gov)
    P2, N=2, Active, not recruiting, University of Maryland, Baltimore | Trial completion date: Nov 2024 --> Aug 2027
    Trial completion date • Minimal residual disease
    |
    CD81 (CD81 Molecule)
    |
    CD19 positive
    |
    Blincyto (blinatumomab)
    2ms
    Phase II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Blincyto (blinatumomab) • Scemblix (asciminib)
    2ms
    DLI-TARGET: Allogeneic Donor Lymphocyte Infusions Combined With Blinatumomab (clinicaltrials.gov)
    P2, N=0, Withdrawn, Ludwig-Maximilians - University of Munich | N=12 --> 0 | Unknown status --> Withdrawn
    Enrollment change • Trial withdrawal • Minimal residual disease
    |
    cytarabine • Blincyto (blinatumomab)
    2ms
    A Study Comparing the Combination of Dasatinib and Chemotherapy Treatment With or Without Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or Philadelphia Chromosome-Like (Ph-Like) ABL-Class B-Cell Acute Lymphoblastic Leukemia (B-ALL) (clinicaltrials.gov)
    P3; Initiation date: Jan 2024 --> Apr 2024
    Trial initiation date
    |
    ABL1 (ABL proto-oncogene 1) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • PDGFRA (Platelet Derived Growth Factor Receptor Alpha) • CD19 (CD19 Molecule) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • CSF1R (Colony stimulating factor 1 receptor)
    |
    CD19 expression
    |
    TruSight RNA Pan-Cancer Panel
    |
    dasatinib • imatinib • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • thioguanine • Starasid (cytarabine ocfosfate)
    2ms
    Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax (clinicaltrials.gov)
    P1/2, N=90, Recruiting, St. Jude Children's Research Hospital | Trial primary completion date: Aug 2024 --> Aug 2025
    Trial primary completion date
    |
    Venclexta (venetoclax) • dasatinib • cytarabine • cyclophosphamide • etoposide IV • Blincyto (blinatumomab) • vincristine • navitoclax (ABT 263) • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl)
    2ms
    NCI-2018-01078: Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=90, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Nov 2024 --> Nov 2025 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    cytarabine • Iclusig (ponatinib) • Blincyto (blinatumomab) • methotrexate • Starasid (cytarabine ocfosfate)
    2ms
    Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab (clinicaltrials.gov)
    P1/2, N=40, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • Tecartus (brexucabtagene autoleucel)
    2ms
    Golden Gate Study: Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P3, N=287, Recruiting, Amgen | Trial completion date: Apr 2031 --> Sep 2031 | Trial primary completion date: Jul 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Blincyto (blinatumomab)
    2ms
    A041703: Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=64, Recruiting, National Cancer Institute (NCI) | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD22 (CD22 Molecule)
    |
    CD22 positive • CD22 expression
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    2ms
    Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=44, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Mar 2025 | Trial primary completion date: Dec 2023 --> Mar 2025
    Trial completion date • Trial primary completion date
    |
    CD19 positive
    |
    lenalidomide • Blincyto (blinatumomab)
    2ms
    A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma (clinicaltrials.gov)
    P1, N=35, Completed, Amgen | Phase classification: P1b --> P1
    Phase classification
    |
    Blincyto (blinatumomab)
    3ms
    Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Chen Suning | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    cytarabine • Blincyto (blinatumomab)
    3ms
    ABC: A Single-arm, Open-label Study of Olverembatinib, CD3/CD19 Bispecific T-cell Engager, and Chidamide in Patients With Newly Diagnosed Ph+ALL (clinicaltrials.gov)
    P2, N=67, Recruiting, Nanfang Hospital, Southern Medical University
    New P2 trial
    |
    ABL1 (ABL proto-oncogene 1)
    |
    Blincyto (blinatumomab) • prednisone • Epidaza (chidamide) • Nailike (olverembatinib)
    3ms
    HAP2HCT: TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies (clinicaltrials.gov)
    P2, N=140, Active, not recruiting, St. Jude Children's Research Hospital | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FLT3 (Fms-related tyrosine kinase 3) • RUNX1 (RUNX Family Transcription Factor 1) • KMT2A (Lysine Methyltransferase 2A) • ETV6 (ETS Variant Transcription Factor 6) • WT1 (WT1 Transcription Factor) • CREBBP (CREB binding protein) • NUP98 (Nucleoporin 98 And 96 Precursor 2) • NSD1 (Nuclear Receptor Binding SET Domain Protein 1) • HOXA9 (Homeobox A9) • NUP214 (Nucleoporin 214) • CBFA2T3 (CBFA2/RUNX1 Partner Transcriptional Co-Repressor 3) • GLIS2 (GLIS Family Zinc Finger 2) • KAT6A (Lysine Acetyltransferase 6A) • KDM5A (Lysine Demethylase 5A) • DEK (DEK Proto-Oncogene) • AFDN (Afadin, Adherens Junction Formation Factor) • MLLT10 (MLLT10 Histone Lysine Methyltransferase DOT1L Cofactor)
    |
    FLT3-ITD mutation • WT1 mutation • MLL fusion • NUP98-NSD1 fusion
    |
    cyclophosphamide • Blincyto (blinatumomab) • melphalan • fludarabine IV • thiotepa • Neupogen (filgrastim)
    3ms
    NCI-2018-01186: Low-Intensity Chemotherapy, Ponatinib and Blinatumomab in Treating Patients With Philadelphia Chromosome-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P2, N=21, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    Rituxan (rituximab) • cytarabine • Iclusig (ponatinib) • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • Neulasta (pegfilgrastim) • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate)
    3ms
    ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT (clinicaltrials.gov)
    P2, N=3, Terminated, Prof. Christina Peters | N=32 --> 3 | Recruiting --> Terminated; Terminated by Amgen Limited
    Enrollment change • Trial termination • Minimal residual disease
    |
    Blincyto (blinatumomab)
    4ms
    Treatment response of a two-dose regimen of dose-adjusted inotuzumab ozogamicin in relapsed/refractory B-cell acute lymphoblastic leukemia (PubMed, Zhonghua Xue Ye Xue Za Zhi)
    Fourteen patients underwent both CD19 and CD22 CAR-T-cell therapy, four underwent CD19 CAR-T-cell therapy, and three underwent blinatumomab therapy. Grade 1-3 hepatotoxicity occurred in five patients (23.8% ), one child with no response experienced hepatic veno-occlusive disease (HVOD) during salvage transplantation and recovered completely. For patients with heavily treated R/R B-ALL, including those who had undergone allo-HSCT and CD19/CD22 CAR-T-cell therapy, the two-dose regimen of inotuzumab resulted in a CR rate of 66.7%, and the frequency of hepatotoxicity and HVOD was low.
    Journal
    |
    CD22 (CD22 Molecule)
    |
    CD22 expression
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    4ms
    Blina-CELL: Blinatumomab Followed by High-dose Chemotherapy for Ph-negative Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov)
    P2, N=45, Active, not recruiting, Institute of Hematology and Blood Transfusion, Czech Republic | Trial completion date: Jan 2026 --> Jul 2024 | Trial primary completion date: May 2025 --> Feb 2024
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    Blincyto (blinatumomab)
    4ms
    Multiparameter flow cytometry and ClonoSEQ correlation to evaluate precursor B-lymphoblastic leukemia measurable residual disease. (PubMed)
    Our results show strong correlation between COG MFC and ClonoSEQ (r = 0.96), and both methods are complementary. Clonal evolution may occur, and blinatumomab immunotherapy may impact MFC B-ALL MRD evaluation.
    Journal
    |
    clonoSEQ
    |
    Blincyto (blinatumomab)
    4ms
    Lineage switch of KMT2A-rearranged adult B-lineage acute lymphoblastic leukemia following bispecific T-cell engager and monoclonal antibody therapy. (PubMed, J Hematop)
    After the initial induction chemotherapy, her disease remained refractory, and the patient received salvage immunotherapy with blinatumomab and inotuzumab ozogamicin. We present this case to highlight the potential of KMT2A-rearranged B-ALL to undergo lineage switch following B-cell targeted therapy. Patients with this kind of B-ALL should therefore be closely monitored to capture potential changes in the nature of the disease and prompt appropriate treatment.
    Journal
    |
    KMT2A (Lysine Methyltransferase 2A) • AFF1 (AF4/FMR2 Family Member 1)
    |
    MLL rearrangement • Chr t(4;11)(q21;q23)
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    4ms
    SOHO State of the Art Updates and Next Questions: Update on the Approach to Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia. (PubMed, Clin Lymphoma Myeloma Leuk)
    Treatment with blinatumomab and ponatinib resulted in a CMR rate of 84%, a 2-year event-free survival (EFS) of 78%, and a 2-year OS rate of 90%; only 1 patient underwent HSCT. Achieving NGS MRD negativity can also identify patients who may have durable remissions with a low risk of relapse. Herein, we discuss the current approach to the management of adults with Ph-positive ALL, the role of HSCT, MRD monitoring, and future therapies.
    Review • Journal
    |
    ABL1 (ABL proto-oncogene 1)
    |
    Iclusig (ponatinib) • Blincyto (blinatumomab)
    4ms
    TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II (clinicaltrials.gov)
    P1/2, N=90, Recruiting, Tanja Andrea Gruber | Not yet recruiting --> Recruiting
    Enrollment open
    |
    KMT2A (Lysine Methyltransferase 2A)
    |
    CD19 positive
    |
    bortezomib • Blincyto (blinatumomab) • Zolinza (vorinostat) • dexamethasone • mitoxantrone • ziftomenib (KO-539) • mercaptopurine
    4ms
    How to Manage Philadelphia-Positive Acute Lymphoblastic Leukemia in Resource-Constrained Settings. (PubMed, Cancers (Basel))
    The T315I mutation is the most common mechanism for disease resistance, being targetable to ponatinib. Blinatumomab, a bispecific antibody, has shown significant synergy with TKIs in treating this disease. It serves as an excellent salvage therapy, aside from achieving outstanding results when incorporated into the frontline.
    Review • Journal
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • IKZF1 (IKAROS Family Zinc Finger 1)
    |
    ABL1 T315I
    |
    Iclusig (ponatinib) • Blincyto (blinatumomab)
    4ms
    Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL (clinicaltrials.gov)
    P2, N=35, Recruiting, Chen Suning | Trial completion date: Oct 2023 --> Mar 2024 | Trial primary completion date: Aug 2023 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    cytarabine • Blincyto (blinatumomab)
    4ms
    Blinatumomab for Treatment of R/R or MRD-positive CD19-Positive MPAL (clinicaltrials.gov)
    P2, N=2, Active, not recruiting, University of Maryland, Baltimore | Trial completion date: Nov 2025 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Minimal residual disease
    |
    CD81 (CD81 Molecule)
    |
    CD19 positive
    |
    Blincyto (blinatumomab)
    5ms
    Blinatumomab Therapy for Low Level Minimal Residual Disease Detected By Next-Generation Sequencing in Adult B-Cell Acute Lymphoblastic Leukemia (TCT-ASTCT-CIBMTR 2024)
    In B cell ALL, Blinatumomab may offer a CIR benefit to pts with low levels of MRD detected on clonoSEQ.
    Clinical • Next-generation sequencing • Minimal residual disease
    |
    clonoSEQ
    |
    Blincyto (blinatumomab)