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DRUG:

Blincyto (blinatumomab)

i
Other names: MEDI 538, MT 103, MT103, AMG-103, MEDI-538, MT-103, AMG 103, AMG103, MEDI538
Company:
Amgen, Astellas, BeiGene
Drug class:
CD3 agonist, CD19 inhibitor
Related drugs:
3d
Decitabine, Venetoclax and Blinatumomab for Maintenance Following HSCT in Patients With Ph-Negative B-ALL (clinicaltrials.gov)
P2, N=30, Recruiting, The First Affiliated Hospital of Soochow University | Not yet recruiting --> Recruiting
Enrollment open
|
Venclexta (venetoclax) • Blincyto (blinatumomab) • decitabine
16d
Addition of Inotuzumab Ozogamicin to Melphalan Plus Fludarabine Reduced-Intensity Conditioning Regimen of Allogeneic Transplantation in Patients with Acute Lymphoblastic Leukemia and Aggressive Lymphoid Malignancies: A Phase II Prospective Trial (ASH 2024)
We recently demonstrated that INO can be added safely to a non-myeloablative conditioning of bendamustine, fludarabine, and rituximab in patients with indolent lymphoid malignancies who required an allogeneic hematopoietic transplantation (HCT) (Am J Hematol 2024)...Patients who received transplants from MUDs received an additional dose of methotrexate 5 mg/m2 on day +11 and 1 mg/kg of rabbit anti-thymocyte globulin IV on days -1 and -2 before HCT...The patient who was in CR2 at transplant had Ph+ ALL and was maintained on ponatinib after HCT. Key prior therapies in ALL patients included blinatumomab (n=5) and INO (n=5)... Our conclusions are limited by the small number of patients due to slow accrual. However, our data suggest that INO is safe when combined with a melphalan plus fludarabine HCT conditioning regimen. The survival outcomes are encouraging and need to be validated in a larger number of patients.
Clinical • P2 data
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TP53 (Tumor protein P53) • KMT2A (Lysine Methyltransferase 2A) • IKZF1 (IKAROS Family Zinc Finger 1) • CD22 (CD22 Molecule) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
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TP53 mutation • CD22 expression • IKZF1 mutation • KMT2A mutation • MLL mutation
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clonoSEQ
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Rituxan (rituximab) • Iclusig (ponatinib) • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • Besponsa (inotuzumab ozogamicin) • bendamustine • melphalan • fludarabine IV
16d
NGS MRD Negativity on Day 28 after Brexu Cel in Adults with R/R ALL Is Associated with Favorable Progression Free Survival (ASH 2024)
Introduction: Brexucabtagene autoleucel (brexu cel) is a CD19-targeted chimeric antigen receptor (CAR) T cell therapy approved for the treatment of adults with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL)...No differences were observed with respect to sex, TP53 mutation status, prior inotuzumab (ino) or blinatumomab (blina) exposure, disease burden prior to CAR, or development of any cytokine release syndrome (CRS) or any neurotoxicity with brexu cel... In a large real-world cohort of adults with R/R B-ALL infused with brexu cel, we identified practice variation regarding the use of consolidative HCT. Among brexu cel recipients who entered an MRD- CR, we identified ClonoSeq NGS MRD negativity as a novel predictive factor of favorable oncologic outcomes, even without a consolidative HCT. Similar results have been obtained in pediatric ALL patietns ftreated with 41BB-based tisagenleucleucel (Pulsipher et al., Blood Cancer Discovery 2022).
Clinical • Next-generation sequencing • IO biomarker • Minimal residual disease
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TP53 (Tumor protein P53)
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TP53 mutation
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clonoSEQ
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • Tecartus (brexucabtagene autoleucel)
16d
Impact of TP53 Mutation on Survival Outcomes in Acute Lymphoblastic Leukemia at a Tertiary Center (ASH 2024)
Because of the above, further research is needed to explore whether using upfront immunotherapy like inotuzumab ozogamicin or blinatumomab in the upfront setting, as well as administering allogeneic transplant early in the treatment course of muTP53-ALL would decrease the risk of relapse and improve long-term survival. The muTP53-ALL patients had similar CCR to first-line therapy to wtTP53-ALL. However, they had worse OS, likely because of relapses. The findings highlight the significant impact of TP53 mutation on outcomes in ALL.
IO biomarker
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TP53 (Tumor protein P53) • ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
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TP53 mutation • TP53 wild-type • BCR-ABL1 mutation
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clonoSEQ
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
16d
Improved Outcomes of Adult Patients with Philadelphia-like Acute Lymphoblastic Leukemia (Ph-Like ALL) Treated within an Integrated Leukemia/Transplant Program with Incorporation of Pediatric Inspired Regimens and Early Allogeneic Transplant (ASH 2024)
Blinatumomab was not used during consolidation therapy in the reported patients. Its incorporation in the routine therapy of newly diagnosed patients may increase the proportion of patients receiving AHCT in a MRD negative state and further improve outcomes in this historically poor risk patient population.
Clinical
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • JAK2 (Janus kinase 2) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • CRLF2 (Cytokine Receptor Like Factor 2) • CSF1R (Colony stimulating factor 1 receptor)
|
CRLF2 rearrangement • JAK2 rearrangement
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clonoSEQ
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Blincyto (blinatumomab)
16d
Concurrent Blinatumomab and Human Leukocyte Antigen-Mismatched Cellular Therapy in Patients with High-Risk B-Cell Acute Lymphoblastic Leukemia, a Phase I Prospective Cohort Study (ASH 2024)
In this study, we infused allogeneic donor lymphocytes from haploidentical donors to patients with acute lymphoblastic leukemia who were receiving blinatumomab concurrently. Dose escalation of the T cell dose of the infused product was performed, while we monitored for unwanted effects from the T cell infusion. Starting doses were very small, 10e6 CD3+ cells/kg of recipient body weight, final doses were 100-fold larger, 10e8 CD3+/kg.
Clinical • P1 data
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CD19 (CD19 Molecule)
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CD19 expression
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clonoSEQ
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Blincyto (blinatumomab)
16d
Measurable Residual Disease in Adult B Lymphoblastic Leukemia: A Study of Concordance between Multiparametric Flow Cytometry, Next-Generation Sequencing of Immunoglobulin Gene Rearrangements, and Quantitative PCR (ASH 2024)
This study involved adult patients aged 19 or older with B-ALL, treated with modified hyper-CVAD (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) and allogeneic hematopoietic stem cell transplant (allogeneic-HSCT) at Catholic Hematology Hospital from May 2022 to June 2024...Poor MRD response was defined as > 0.1%, and complete MRD response as < 0.001%, and poor MRD responders were treated with MRD-directed therapy using blinatumomab or next-generation tyrosine kinase inhibitors... Our data suggested all MRD detection methods showed acceptable power and good concordance rates, but the detection power was different between Ph-positive and Ph-negative ALL. We also suggested MRD-directed therapeutic strategies might predict the significant time point of MRD for the prediction of survival outcomes.
Clinical • Next-generation sequencing • Discordant
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ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • CD73 (5'-Nucleotidase Ecto) • CD123 (Interleukin 3 Receptor Subunit Alpha) • CD22 (CD22 Molecule) • CEACAM6 (CEA Cell Adhesion Molecule 6) • IL3RA (Interleukin 3 Receptor Subunit Alpha) • NRP1 (Neuropilin 1)
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LymphoTrack® Dx IGH Assay
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doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • vincristine
16d
Measurable Residual Disease Monitoring for Philadelphia Positive Acute Lymphoblastic Leukemia (Ph+ALL) in the Setting of the Gimema ALL2820 Trial (ASH 2024)
Samples derived from cases from both the experimental and the control arm, based respectively on ponatinib followed by blinatumomab and on a combination of imatinib and conventional chemotherapy. While some groups reported a higher predictive prognostic power of IG/TR monitoring, our findings do not confirm these data, also in view of the very low rate of relapses so far observed. Nevertheless, a double-hit strategy may be informative for MRD monitoring and possibly for the distinction between typical/lymphoid Ph+ ALL vs multilineage/CML-like Ph+ ALL.
IO biomarker
|
ABL1 (ABL proto-oncogene 1) • IKZF1 (IKAROS Family Zinc Finger 1)
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ABL1 fusion
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LymphoTrack® Dx IGH Assay • LymphoTrack® Dx IGK Assay
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imatinib • Iclusig (ponatinib) • Blincyto (blinatumomab)
16d
Clearance of Very Low Levels of Measurable Residual Disease with Blinatumomab Significantly Improves Outcomes in B-Cell Acute Lymphoblastic Leukemia (ASH 2024)
Non-responders to blinatumomab have poor outcomes (2-year RFS: 25%) but may be salvaged by ASCT. The relatively low rate of NGS MRD negativity with blinatumomab monotherapy (31% in Ph- B-ALL) highlights the need for combination therapies in B-ALL.
IO biomarker
|
TP53 (Tumor protein P53) • ABL1 (ABL proto-oncogene 1) • KMT2A (Lysine Methyltransferase 2A)
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TP53 mutation
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clonoSEQ
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Blincyto (blinatumomab)
16d
Early Achievement of Deep Measurable Residual Disease (MRD) Negativity Identifies Patients with B-Cell Acute Lymphoblastic Leukemia (ALL) Who Have Excellent Long-Term Outcomes and Do Not Benefit from Allogeneic Stem Cell Transplant, Irrespective of Baseline High-Risk Cytomolecular Features (ASH 2024)
Frontline therapy was hyper-CVAD-based ± immunotherapy (e.g. inotuzumab ozogamicin and/or blinatumomab) in 43% (n=69), mini-hyper-CVD-based ± immunotherapy in 28% (n=45), and chemotherapy-free in 29% (n=47, all of whom were Ph+). Early achievement of NGS MRD negativity identifies pts with excellent outcomes after frontline therapy. Importantly, no relapses were observed in pts with HR cytogenetic/molecular features who achieved early NGS MRD negativity, suggesting that early MRD dynamics should be included in ALL risk stratification systems. Pts with HR Ph- ALL who achieve deep MRD negativity within the first 6 months of frontline therapy do not appear to benefit from allogeneic SCT.
Clinical • IO biomarker • Minimal residual disease
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TP53 (Tumor protein P53) • KMT2A (Lysine Methyltransferase 2A)
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TP53 mutation
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clonoSEQ
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
16d
CD19-CAR T Cells As Definitive Consolidation for Older Adults with B-Cell Acute Lymphoblastic Leukemia in First Complete Remission: A Pilot Study (ASH 2024)
Ten (77%) pts received blinatumomab as part of initial therapy...Among pts who completed the DLT period (n=11), 7 (64%) experienced transient grade (G) 1 cytokine release syndrome (CRS) that resolved with tocilizumab +/- corticosteroid... The use of CAR-T in older adults with B-ALL in CR1 appears safe with no observed ICANS or ≥G2 CRS. CAR T cells had a robust expansion in the blood and CSF despite the low antigen setting. We have observed preliminary durable remissions and pts maintained function and cognition on day 100 post CAR-T.
Clinical • CAR T-Cell Therapy
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CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • KMT2A (Lysine Methyltransferase 2A) • EP300 (E1A binding protein p300) • TCF3 (Transcription Factor 3) • PBX1 (PBX Homeobox 1) • ZNF384 (Zinc Finger Protein 384)
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CDKN2A deletion
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clonoSEQ
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Blincyto (blinatumomab) • Actemra IV (tocilizumab)
18d
Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax (clinicaltrials.gov)
P1/2, N=35, Active, not recruiting, St. Jude Children's Research Hospital | N=98 --> 35 | Trial completion date: Jul 2029 --> Mar 2025 | Trial primary completion date: Aug 2025 --> Jun 2024
Enrollment change • Trial completion date • Trial primary completion date
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Venclexta (venetoclax) • dasatinib • cytarabine • cyclophosphamide • etoposide IV • Blincyto (blinatumomab) • vincristine • navitoclax (ABT 263) • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl)
23d
Enrollment change • Combination therapy • Checkpoint inhibition
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CD19 (CD19 Molecule)
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CD19 expression
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Opdivo (nivolumab) • cytarabine • Blincyto (blinatumomab) • methotrexate • vincristine • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Hemady (dexamethasone tablets) • ABP 206 (nivolumab biosimilar) • Asparec (PEGylated recombinant Erwinia chrysantemi-derived L-asparaginase) • Starasid (cytarabine ocfosfate) • dexamethasone injection
23d
Philadelphia chromosome-positive or Philadelphia chromosome-like B-cell precursor acute lymphoblastic leukemia with multilineage involvement in pediatric patients: a report of two cases and literature review. (PubMed, Pharmacogenet Genomics)
This report presents two pediatric ALL cases (one Ph+ and one Ph-like) with minimal residual disease negativity established by multicolor flow cytometry but persistent transcript detection by quantitative PCR (qPCR) even after second-line treatment with tyrosine kinase inhibitors combined with blinatumomab immunotherapy. Using droplet digital PCR, BCR::ABL1 or TPM3::PDGFRB transcripts were identified in CD19+ cells as well as in non-CD19+ cells, suggesting the presence of a Ph+ or Ph-like ALL-M subtype originating from hematopoietic stem cells. This report provides information for better characterization, diagnosis, and treatment of these ALL subtypes.
Review • Journal • IO biomarker
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ABL1 (ABL proto-oncogene 1) • PDGFRB (Platelet Derived Growth Factor Receptor Beta) • TPM3 (Tropomyosin 3)
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Blincyto (blinatumomab)
25d
New trial
|
Blincyto (blinatumomab)
28d
Complete Remission with Inotuzumab Ozogamicin as Fourth-Line Salvage Therapy in a Child with Relapsed/Refractory Acute Lymphoblastic Leukemia. (PubMed, Hematol Rep)
Case presentation: Herein, we present the case of a 23-month-old girl with high-risk B-ALL who experienced very early isolated medullary relapse; following the failure of conventional chemotherapy according to the ALL-IC REL 2016 protocol, she went on to receive the bispecific T-cell engager (BiTE) blinatumomab and subsequently, due to refractory disease, the combination of fludarabine, cytarabine, and the proteasome inhibitor bortezomib without achieving remission. The minimal residual disease (MRD) was 0.08% on day 28, and InO was continued, thus achieving MRD negativity; the patient successfully underwent an allogeneic stem cell transplantation from a matched family donor. Our case highlights the efficacy and safety of InO as a salvage treatment in the setting of relapsed B-ALL refractory not only to conventional chemotherapy but also to novel treatments, such as blinatumomab and bortezomib.
Journal
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CD22 (CD22 Molecule)
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CD22 positive • CD22 expression • CD22 overexpression
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cytarabine • bortezomib • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • fludarabine IV
1m
A Study of OnCARlytics (CF33-CD19) in Combination with Blinatumomab in Adults with Advanced or Metastatic Solid Tumors (OASIS) (clinicaltrials.gov)
P1, N=33, Recruiting, Imugene Limited | N=52 --> 33 | Trial completion date: Sep 2025 --> May 2029 | Trial primary completion date: Sep 2024 --> Jun 2027
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
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Blincyto (blinatumomab) • VAXinia (CF33-hNIS) • onCARlytics (CF33-CD19)
1m
New trial
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Blincyto (blinatumomab)
1m
Clinical analysis of 7 cases of acute B cell lymphoblastic leukemia with t (17;19) (q21-22;p13)/TCF3-HLF fusion (PubMed, Zhonghua Xue Ye Xue Za Zhi)
Two patients did not achieve remission even after two rounds of induction chemotherapy, with one achieving complete remission after treatment with blinatumomab immunotherapy...Five patients died, while two patients survived with sustained complete remission. TCF3-HLF-positive B-ALL is rare and has a high relapse rate and poor prognosis.
Retrospective data • Journal • IO biomarker
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CD33 (CD33 Molecule) • TCF3 (Transcription Factor 3)
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CD33 positive • CD33 expression
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Blincyto (blinatumomab)
1m
Phase classification • Combination therapy
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Keytruda (pembrolizumab) • Blincyto (blinatumomab)
1m
Trial completion date • Combination therapy • Checkpoint inhibition • IO biomarker
|
CD19 (CD19 Molecule) • CD34 (CD34 molecule) • MME (Membrane Metalloendopeptidase)
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CD19 expression
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Opdivo (nivolumab) • Yervoy (ipilimumab) • Blincyto (blinatumomab) • ABP 206 (nivolumab biosimilar)
1m
Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) (clinicaltrials.gov)
P4, N=10, Terminated, Amgen | N=45 --> 10 | Trial completion date: Dec 2025 --> Sep 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Sep 2024; The decision to terminate is not based on safety or efficacy but due to slow enrollment impacting the ability to complete the study as planned.
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Minimal residual disease
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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) | Trial completion date: Dec 2027 --> Dec 2028 | Initiation date: Oct 2024 --> Jan 2025 | Trial primary completion date: Dec 2027 --> Dec 2028
Trial completion date • Trial initiation date • Trial primary completion date • Combination therapy
|
MCL1 (Myeloid cell leukemia 1) • KMT2A (Lysine Methyltransferase 2A) • BCL2L1 (BCL2-like 1)
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BCL2 expression
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Venclexta (venetoclax) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • vincristine • daunorubicin • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • thioguanine • Hemady (dexamethasone tablets) • Starasid (cytarabine ocfosfate) • prednisolone
1m
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)
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CD19 expression
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TruSight RNA Pan-Cancer Panel
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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)
1m
Enrollment closed • Enrollment change
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Rituxan (rituximab) • cyclophosphamide • Blincyto (blinatumomab) • sirolimus • melphalan • fludarabine IV • mesna • thiotepa • Neupogen (filgrastim)
2ms
Functional Activity of Cytokine-Induced Killer Cells Enhanced by CAR-CD19 Modification or by Soluble Bispecific Antibody Blinatumomab. (PubMed, Antibodies (Basel))
CAR-MNZ bearing the CD28-OX40-CD3ζ signaling modules, and CAR-BG2, designed on the Tisagenlecleucel CAR sequence (Kymriah®), carrying the 4-1BB and CD3ζ signaling elements, were employed. CIK + Blina displayed strongest NFAT and IFN-ɣ induction, whereas CARCIK-BG2 demonstrated superior synapse formation. All the effectors have shown therapeutic activity in vivo against the CD19+ Daudi tumor model, with CARCIK cells showing a more durable response compared to CIK + Blina, likely due to the short half-life of Blina in this model.
Journal
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CD19 (CD19 Molecule) • IL2 (Interleukin 2)
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CD19 expression
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Blincyto (blinatumomab) • Kymriah (tisagenlecleucel-T)
2ms
New P2/3 trial
|
Blincyto (blinatumomab)
2ms
Blinatumomab for CNI-Resistant/Intolerant SRNS in Children (clinicaltrials.gov)
P1, N=6, Recruiting, The Children's Hospital of Zhejiang University School of Medicine
New P1 trial
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Blincyto (blinatumomab)
2ms
A critical review of management of allogeneic transplant-eligible adults with Ph+ acute lymphoblastic leukaemia. (PubMed, Br J Haematol)
Can chemotherapy-free approaches, such as blinatumomab in conjunction with more potent TKIs, obviate the need for an allograft in high-risk patients?...Can salvage therapy and a subsequent allograft cure patients who relapse after not being transplanted in CR1? This manuscript reviews the latest data influencing contemporary management and discusses these controversies.
Review • Journal
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ABL1 (ABL proto-oncogene 1)
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ABL1 fusion
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Blincyto (blinatumomab)
2ms
Case of B-acute lymphoblastic leukaemia with t(1;19)(q23;p13.3) TCF3::PBX1 and co-occurring CBL mutation in an elderly patient. (PubMed, BMJ Case Rep)
She was treated with modified Ph-negative EWALL induction (Vincristine, Idarubicin, dexamethasone) and achieved a complete remission. However, she subsequently experienced an early relapse and was refractory to targeted therapy with blinatumomab. After treatment with inotuzumab ozogamicin, she achieved a second complete remission...It demonstrates that patients with ostensibly favourable prognostic factors may experience poor response rates to traditional chemotherapy as well as targeted salvage agents. It also illustrates the challenges of treating B-ALL in the elderly population.
Journal
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CBL (Cbl proto-oncogene) • TCF3 (Transcription Factor 3) • PBX1 (PBX Homeobox 1)
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CBL mutation
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Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • vincristine • idarubicin hydrochloride
3ms
Trial completion date • Trial primary completion date • Combination therapy
|
Venclexta (venetoclax) • dasatinib • Rituxan (rituximab) • Blincyto (blinatumomab) • methotrexate • Truxima (rituximab-abbs)
3ms
Cost-effectiveness of blinatumomab for the treatment of B‑precursor acute lymphoblastic leukemia pediatric patients with high‑risk first‑relapse in Mexico. (PubMed, Leuk Res)
Blinatumomab was associated with greater benefit in terms of OS and EFS relative to SC. Probabilistic, deterministic, and scenario analyses indicate that blinatumomab represents the best value for money. Therefore, blinatumomab administered as part of consolidation therapy in B-ALL pediatric patients with high-risk first relapse is a cost-effective option.
Clinical • Journal • HEOR • Cost-effectiveness • Cost effectiveness
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CD19 (CD19 Molecule)
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Blincyto (blinatumomab)
3ms
Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia can be Treated with Chemotherapy-Free Regimens without Transplant (SOHO 2024)
Significant progress has been made in recent years in the treatment of adults with Philadelphia chromosome-positive (Ph-positive) acute lymphoblastic leukemia (ALL).1 Combining BCR::ABL1 tyrosine kinase inhibitors (TKIs) with intensive chemotherapy regimens like hyper-fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) and others has greatly improved patient outcomes.2 As a result, allogeneic hematopoietic stem cell transplantation (HSCT) has become an additional valuable option...Specifically, the 5-year PFS rates were 81% with hyper-CVAD plus ponatinib, 54% with hyper-CVAD plus dasatinib, and 64% with hyper-CVAD plus imatinib...In contrast to the D-ALBA trial, only two patients underwent HSCT.26 Whether the combination of blinatumomab and ponatinib can overcome the poor prognosis of IKZF1plus and the negative impact of an elevated white blood cell count (higher than 70×109/L, as shown in a multivariate analysis to correlate with a higher risk of relapse) remains to be determined.Asciminib is a first-in-class selective allosteric ABL myristoyl pocket (STAMP) inhibitor that was evaluated in combination with dasatinib and prednisone in a phase 1 trial of 25 patients with Ph-positive ALL, with a median age of 65 years (range, 33 to 85 years).27 Fourteen patients were enrolled in the dose-escalation cohort and 11 in the dose-expansion cohort...Eighteen patients with newly diagnosed Ph-positive ALL received dasatinib/vincristine/prednisone followed by sequential infusions of CD19 and CD22 CAR T cells...The chemotherapy-free regimens involving TKIs alongside blinatumomab have demonstrated outstanding outcomes in the frontline setting, particularly with the utilization of ponatinib. The combination of ponatinib and blinatumomab exhibits high efficacy, with CMR rates of 83% by PCR and 98% by ClonoSEQ and a 3-year OS rate of 91%, with only two patients undergoing HSCT.
ABL1 (ABL proto-oncogene 1) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CRLF2 (Cytokine Receptor Like Factor 2) • IKZF1 (IKAROS Family Zinc Finger 1) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • CD22 (CD22 Molecule) • PAX5 (Paired Box 5)
|
clonoSEQ
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dasatinib • imatinib • cytarabine • Iclusig (ponatinib) • doxorubicin hydrochloride • cyclophosphamide • Blincyto (blinatumomab) • vincristine • Scemblix (asciminib)
3ms
New P2 trial
|
Blincyto (blinatumomab) • Uplizna (inebilizumab-cdon)
3ms
Blinatumomab in Treating Patients With B-cell Acute Lymphoblastic Leukemia With Minimal Residual Disease (clinicaltrials.gov)
P2, N=36, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2024 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion date • Trial primary completion date • Minimal residual disease
|
Blincyto (blinatumomab)
3ms
Effective treatment of relapsed/refractory CD19-positive B/T-type mixed-phenotype acute leukemia with blinatumomab: A case report. (PubMed, EJHaem)
He underwent cord blood transplantation with the conditioning regimen of total body irradiation plus cyclophosphamide and cytarabine with granulocyte-colony stimulating factor priming. Prophylaxis for graft versus host disease was performed with short-term methotrexate and cyclosporin...At that time, he was treated with inotuzumab ozogamicin because the blasts expressed CD22 (75.4%), but this was ineffective. He was next administered blinatumomab with dexamethasone pretreatment, resulting in a complete remission (CR)...He has still maintained a CR for 12 months. Blinatumomab might be a promising treatment and a bridge to stem cell transplantation even in relapsed/refractory CD19-expressing MPAL-B/T.
Journal
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CD19 (CD19 Molecule) • CD22 (CD22 Molecule) • MPO (Myeloperoxidase)
|
cytarabine • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • Besponsa (inotuzumab ozogamicin) • dexamethasone • cyclosporine
3ms
The characterization and the impact of CSF pleocytosis during blinatumomab therapy for adult acute lymphoblastic leukemia. (PubMed, Leuk Lymphoma)
Analysis of CSF by flow cytometry showed median CD4:CD8 ratio of 1.34. In conclusion, CSF pleocytosis is prevalent with blinatumomab but only demonstrated lower rates of non-CNS extramedullary relapse but no impact on CNS relapse or neurotoxicity.
Journal
|
CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
Blincyto (blinatumomab)
3ms
Blinatumomab Plus Venetoclax Sequenced With Inotuzumab Ozogamicin in Treating B-ALL (clinicaltrials.gov)
P2, N=20, Recruiting, First Affiliated Hospital of Zhejiang University
New P2 trial
|
Venclexta (venetoclax) • cytarabine • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • dexamethasone • Oncaspar liquid (pegaspargase) • dexamethasone injection • methotrexate IV
4ms
Enrollment open
|
Blincyto (blinatumomab)
4ms
Trial completion date • Trial primary completion date
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Rituxan (rituximab) • cyclophosphamide • Blincyto (blinatumomab) • sirolimus • melphalan • fludarabine IV • mesna • thiotepa • Neupogen (filgrastim)
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 primary completion date: Jun 2024 --> Jun 2025
Trial primary completion date • Minimal residual disease
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CD81 (CD81 Molecule)
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Blincyto (blinatumomab)