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    DRUG CLASS:

    DNA replication inhibitor

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    Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas (NCT06041516)
    Phase 1
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    06/14/2024
    Initiation :
    06/19/2024
    Primary completion :
    10/30/2027
    Completion :
    10/30/2029
    CD4
    |
    ADCT-701
    Inotuzumab Ozogamicin and Blinatumomab in Treating Patients With Newly Diagnosed, Recurrent, or Refractory CD22-Positive B-Lineage Acute Lymphoblastic Leukemia (A041703) (NCT03739814)
    Phase 2
    National Cancer Institute (NCI)
    Recruiting
    Last update posted :
    06/13/2024
    Initiation :
    05/08/2019
    Primary completion :
    02/01/2025
    Completion :
    02/01/2025
    ABL1 • BCR • CD22
    |
    CD22 positive • CD22 expression
    |
    Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin)
    A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate BYON3521 (BYON3521.001) (NCT05323045)
    Phase 1
    Byondis B.V.
    Active, not recruiting
    Last update posted :
    06/07/2024
    Initiation :
    03/21/2022
    Primary completion :
    07/01/2024
    Completion :
    07/01/2024
    MET
    |
    MET amplification • MET mutation • MET expression • MET positive
    |
    BYON3521
    Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia (NCT04915612)
    Phase 1
    M.D. Anderson Cancer Center
    Active, not recruiting
    Last update posted :
    06/07/2024
    Initiation :
    05/21/2021
    Primary completion :
    05/01/2025
    Completion :
    05/01/2025
    CD33
    |
    CD33 positive
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies (LONCA) (NCT05270057)
    Phase 1
    Medical College of Wisconsin
    Recruiting
    Last update posted :
    06/04/2024
    Initiation :
    01/26/2023
    Primary completion :
    05/01/2026
    Completion :
    05/01/2026
    BCL2 • BCL6
    |
    MYC rearrangement • BCL6 rearrangement
    |
    Rituxan (rituximab) • cyclophosphamide • etoposide IV • pegylated liposomal doxorubicin • vincristine • prednisone • Zynlonta (loncastuximab tesirine-lpyl) • Marqibo (vincristine liposomal)
    Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) (APAL2020D) (NCT05183035)
    Phase 3
    LLS PedAL Initiative, LLC
    Recruiting
    Last update posted :
    06/03/2024
    Initiation :
    10/01/2022
    Primary completion :
    02/01/2027
    Completion :
    02/01/2032
    FLT3 • BCL2
    |
    FLT3-ITD mutation
    |
    Venclexta (venetoclax) • cytarabine • azacitidine • Mylotarg (gemtuzumab ozogamicin) • fludarabine IV
    A Study of Inotuzumab Ozogamicin in Chinese Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (NCT05687032)
    Phase 4
    Pfizer
    Active, not recruiting
    Last update posted :
    05/31/2024
    Initiation :
    02/24/2023
    Primary completion :
    08/07/2024
    Completion :
    11/07/2025
    CD22
    |
    CD22 positive
    |
    Besponsa (inotuzumab ozogamicin)
    SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma (NCT04205630)
    Phase 2
    Byondis B.V.
    Completed
    Last update posted :
    05/30/2024
    Initiation :
    05/28/2020
    Primary completion :
    01/26/2023
    Completion :
    04/25/2023
    HER-2
    |
    HER-2 expression
    |
    Herceptin (trastuzumab) • Jivadco (trastuzumab duocarmazine)
    Inotuzumab Ozogamicin in Treating Younger Patients With B-Lymphoblastic Lymphoma or Relapsed or Refractory CD22 Positive B Acute Lymphoblastic Leukemia (AALL1621) (NCT02981628)
    Phase 2
    Children's Oncology Group
    Recruiting
    Last update posted :
    05/30/2024
    Initiation :
    06/19/2017
    Primary completion :
    03/31/2026
    Completion :
    03/31/2026
    KMT2A • CD22
    |
    MLL rearrangement • CD22 expression
    |
    cytarabine • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • leucovorin calcium • Oncaspar liquid (pegaspargase) • mercaptopurine delayed release (DR6MP) • mercaptopurine • Asparlas (calaspargase pegol-mknl) • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Starasid (cytarabine ocfosfate) • cyclophosphamide intravenous
    Study to Evaluate Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (LOTIS 5) (NCT04384484)
    Phase 3
    ADC Therapeutics S.A.
    Recruiting
    Last update posted :
    05/27/2024
    Initiation :
    09/16/2020
    Primary completion :
    06/30/2025
    Completion :
    06/30/2028
    BCL2 • BCL6
    |
    BCL6 rearrangement • BCL2 rearrangement
    |
    gemcitabine • Rituxan (rituximab) • oxaliplatin • Zynlonta (loncastuximab tesirine-lpyl)
    Clinical Trial of SOT102 Antibody Drug Conjugate in Patients With Advanced Gastric and Pancreatic Adenocarcinoma (CLAUDIO-01) (NCT05525286)
    Phase 1/2
    SOTIO Biotech a.s.
    Recruiting
    Last update posted :
    05/27/2024
    Initiation :
    03/31/2022
    Primary completion :
    12/01/2027
    Completion :
    06/01/2028
    CLDN18
    |
    HER-2 overexpression • HER-2 negative • CLDN18.2 expression
    |
    SOT102
    Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia (NCT01409161)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    05/24/2024
    Initiation :
    10/05/2011
    Primary completion :
    12/18/2025
    Completion :
    12/18/2025
    RARA • PML
    |
    Mylotarg (gemtuzumab ozogamicin) • Vesanoid (tretinoin) • arsenic trioxide
    Testing the Combination of Inotuzumab Ozogamicin and Lower Dose Chemotherapy Compared to Usual Chemotherapy for Adults With B-Cell Acute Lymphoblastic Leukemia or B-Cell Lymphoblastic Lymphoma (NCT05303792)
    Phase 2
    Alliance for Clinical Trials in Oncology
    Recruiting
    Last update posted :
    05/23/2024
    Initiation :
    02/27/2023
    Primary completion :
    05/31/2025
    Completion :
    05/01/2028
    CD20 • CD22
    |
    CD20 expression • CD22 positive
    |
    Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • methotrexate • Besponsa (inotuzumab ozogamicin) • vincristine • prednisone • mercaptopurine • dexamethasone injection
    Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia (NCT03150693)
    Phase 3
    Alliance for Clinical Trials in Oncology
    Suspended
    Last update posted :
    05/23/2024
    Initiation :
    06/01/2017
    Primary completion :
    03/01/2025
    Completion :
    08/01/2025
    ABL1 • BCR • CD20 • CD22 • ITGB1
    |
    CD20 positive • CD22 positive
    |
    Rituxan (rituximab) • cytarabine • doxorubicin hydrochloride • cyclophosphamide • Besponsa (inotuzumab ozogamicin) • vincristine • daunorubicin • Oncaspar liquid (pegaspargase) • mercaptopurine • thioguanine • cyclophosphamide intravenous
    Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia (NCI-2019-01726) (NCT03900949)
    Phase 1
    Uma Borate
    Suspended
    Last update posted :
    05/22/2024
    Initiation :
    03/13/2019
    Primary completion :
    01/01/2025
    Completion :
    01/01/2025
    FLT3 • CD33
    |
    CD33 positive • CD33 expression
    |
    cytarabine • Rydapt (midostaurin) • Mylotarg (gemtuzumab ozogamicin) • daunorubicin • Starasid (cytarabine ocfosfate)
    Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia (SWOG-S0703) (NCT00658814)
    Phase 2
    National Cancer Institute (NCI)
    Active, not recruiting
    Last update posted :
    05/17/2024
    Initiation :
    12/01/2008
    Primary completion :
    06/01/2013
    Completion :
    03/07/2025
    CD4
    |
    azacitidine • Mylotarg (gemtuzumab ozogamicin)
    ADCT-602 in Treating Patients With Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia (NCI-2018-02016) (NCT03698552)
    Phase 1/2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    05/15/2024
    Initiation :
    08/24/2018
    Primary completion :
    12/31/2025
    Completion :
    12/31/2025
    CD22
    |
    CD22 expression
    |
    epratuzumab-cys-tesirine (ADCT-602)
    Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia (NCT04207190)
    Phase 1
    Roswell Park Cancer Institute
    Active, not recruiting
    Last update posted :
    05/08/2024
    Initiation :
    10/23/2020
    Primary completion :
    04/01/2025
    Completion :
    04/01/2025
    CD33
    |
    Talzenna (talazoparib) • Mylotarg (gemtuzumab ozogamicin)
    Liposome-encapsulated Daunorubicin-Cytarabine and Gemtuzumab Ozogamicin in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (NCI-2018-01812) (NCT03672539)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    05/08/2024
    Initiation :
    11/07/2018
    Primary completion :
    11/30/2025
    Completion :
    11/30/2025
    CD33
    |
    CD33 positive
    |
    Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation)
    Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia (NCT05645718)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    05/03/2024
    Initiation :
    07/14/2023
    Primary completion :
    12/31/2027
    Completion :
    12/31/2029
    CD19 • CD22
    |
    CD19 expression
    |
    Rituxan (rituximab) • cytarabine • cyclophosphamide • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • vincristine • prednisone • mercaptopurine • Neulasta (pegfilgrastim) • Depocyte (liposomal cytarabine)
    A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to (EU PIP Study) (NCT05748171)
    Phase 2
    Pfizer
    Recruiting
    Last update posted :
    04/30/2024
    Initiation :
    05/17/2023
    Primary completion :
    07/11/2028
    Completion :
    07/09/2031
    TP53 • KMT2A • CD22 • TCF3 • PBX1
    |
    KMT2A rearrangement • MLL rearrangement • CD22 positive
    |
    Besponsa (inotuzumab ozogamicin)
    Loncastuximab Tesirine in Combination With Rituximab in Patients With Relapsed or Refractory Follicular Lymphoma (NCT04998669)
    Phase 2
    Juan P. Alderuccio, MD
    Recruiting
    Last update posted :
    04/26/2024
    Initiation :
    02/11/2022
    Primary completion :
    08/01/2024
    Completion :
    08/01/2027
    CD19
    |
    CD19 expression
    |
    Rituxan (rituximab) • Zynlonta (loncastuximab tesirine-lpyl)
    A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (NCT04293562)
    Phase 3
    Children's Oncology Group
    Active, not recruiting
    Last update posted :
    04/22/2024
    Initiation :
    07/21/2020
    Primary completion :
    09/30/2027
    Completion :
    09/30/2027
    FLT3
    |
    Xospata (gilteritinib) • etoposide IV • methotrexate • Mylotarg (gemtuzumab ozogamicin) • Vyxeos (cytarabine/daunorubicin liposomal formulation) • mitoxantrone • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) • Erwinase (erwinia asparaginase) • Kidrolase (L-asparaginase) • Leunase (L-asparaginase) • Spectrila (asparaginase Escherichia coli) • Starasid (cytarabine ocfosfate) • dexrazoxane
    Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia (NCT03913559)
    Phase 2
    St. Jude Children's Research Hospital
    Recruiting
    Last update posted :
    04/19/2024
    Initiation :
    05/14/2019
    Primary completion :
    12/01/2024
    Completion :
    01/01/2025
    CD22
    |
    CD22 expression
    |
    cytarabine • methotrexate • Besponsa (inotuzumab ozogamicin) • methylprednisolone sodium succinate
    A Study of Mipasetamab Uzoptirine (ADCT-601) in Participants With Solid Tumors (ADCT-601-102) (NCT05389462)
    Phase 1
    ADC Therapeutics S.A.
    Recruiting
    Last update posted :
    04/18/2024
    Initiation :
    07/13/2022
    Primary completion :
    08/01/2026
    Completion :
    08/01/2027
    AXL
    |
    gemcitabine • mipasetamab uzoptirine (ADCT-601)
    Phase II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin (MEGO) for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy (NCT03839446)
    Phase 2
    Robert Redner, MD
    Active, not recruiting
    Last update posted :
    04/18/2024
    Initiation :
    02/28/2019
    Primary completion :
    02/02/2023
    Completion :
    12/22/2028
    CD33
    |
    CD33 expression
    |
    etoposide IV • Mylotarg (gemtuzumab ozogamicin) • mitoxantrone
    IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia (IMGN632-0802) (NCT04086264)
    Phase 1/2
    ImmunoGen, Inc.
    Active, not recruiting
    Last update posted :
    04/18/2024
    Initiation :
    11/06/2019
    Primary completion :
    12/11/2024
    Completion :
    12/11/2024
    IL3RA
    |
    CD123 positive • IL3RA positive
    |
    Venclexta (venetoclax) • azacitidine • decitabine • pivekimab sunirine (PVEK)
    Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia (NCT04793919)
    Phase 2
    Associazione Italiana Ematologia Oncologia Pedi...
    Recruiting
    Last update posted :
    04/15/2024
    Initiation :
    10/09/2019
    Primary completion :
    10/09/2025
    Completion :
    10/10/2027
    RARA • PML
    |
    Mylotarg (gemtuzumab ozogamicin) • arsenic trioxide
    Retrospective Observational Study on Infective Complications and Outcome of Patients With ALL Treated With INO (INO-FIRST) (NCT06025682)
    Phase N/A
    Gruppo Italiano Malattie EMatologiche dell'Adulto
    Recruiting
    Last update posted :
    04/11/2024
    Initiation :
    04/04/2024
    Primary completion :
    01/01/2025
    Completion :
    01/01/2025
    CD22
    |
    CD22 positive
    |
    Besponsa (inotuzumab ozogamicin)
    CLAG-GO for Patients With Persistent, Relapsed or Refractory AML (NCT04050280)
    Phase 2
    University of Maryland, Baltimore
    Recruiting
    Last update posted :
    04/05/2024
    Initiation :
    11/01/2019
    Primary completion :
    06/30/2026
    Completion :
    02/01/2027
    CD33
    |
    cytarabine • Mylotarg (gemtuzumab ozogamicin) • cladribine
    Fractionated Gemtuzumab Ozogamicin in Treating Measurable Residual Disease in Patients With Acute Myeloid Leukemia (NCI-2018-01613) (NCT03737955)
    Phase 2
    University of Washington
    Recruiting
    Last update posted :
    03/27/2024
    Initiation :
    11/30/2018
    Primary completion :
    03/15/2023
    Completion :
    12/31/2024
    CD33
    |
    CD33 expression
    |
    Mylotarg (gemtuzumab ozogamicin)
    A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia (NCT04307576)
    Phase 3
    Mats Heyman
    Recruiting
    Last update posted :
    03/19/2024
    Initiation :
    07/13/2020
    Primary completion :
    06/30/2027
    Completion :
    06/30/2032
    MYC • BCL2 • KMT2A
    |
    MYC rearrangement + BCL2 rearrangement • MLL rearrangement • MYC rearrangement • MYC translocation • BCL2 rearrangement
    |
    imatinib • doxorubicin hydrochloride • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • vincristine • thioguanine
    Inotuzumab Ozogamicin in Treating Patients With B-cell Acute Lymphocytic Leukemia With Positive Minimal Residual Disease (NCI-2018-00936) (NCT03441061)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    03/15/2024
    Initiation :
    02/15/2018
    Primary completion :
    02/28/2025
    Completion :
    02/28/2025
    ABL1 • BCR
    |
    Besponsa (inotuzumab ozogamicin)
    Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation (NCT03856216)
    Phase 2
    M.D. Anderson Cancer Center
    Recruiting
    Last update posted :
    03/13/2024
    Initiation :
    10/28/2019
    Primary completion :
    03/31/2025
    Completion :
    03/31/2025
    CD22 • HLA-DRB1 • HLA-B • HLA-C
    |
    Rituxan (rituximab) • methotrexate • Besponsa (inotuzumab ozogamicin) • bendamustine • melphalan • Truxima (rituximab-abbs) • fludarabine IV • Riabni (rituximab-arrx) • Delito (rituximab biosimilar) • GB241 (rituximab biosimilar) • JHL1101 (rituximab biosimilar) • Neupogen (filgrastim) • Novex (rituximab biosimilar)
    Inotuzumab Ozogamicin Post-Transplant For Acute Lymphocytic Leukemia (NCT03104491)
    Phase 1/2
    Leland Metheny
    Recruiting
    Last update posted :
    02/29/2024
    Initiation :
    07/31/2017
    Primary completion :
    05/01/2024
    Completion :
    05/01/2026
    BCL2 • BCL6 • CD22
    |
    BCL6 rearrangement • CD22 positive • BCL2 rearrangement
    |
    Besponsa (inotuzumab ozogamicin)
    Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma (NCT02315157)
    Phase 1
    Sidney Kimmel Cancer Center at Thomas Jefferson...
    Withdrawn
    Last update posted :
    02/16/2024
    Primary completion :
    01/01/2020
    CD34
    |
    bendamustine
    A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia (NCT05189639)
    Phase N/A
    Pfizer
    Recruiting
    Last update posted :
    02/14/2024
    Initiation :
    12/05/2023
    Primary completion :
    11/17/2027
    Completion :
    11/17/2027
    CD33
    |
    CD33 positive
    |
    Mylotarg (gemtuzumab ozogamicin)
    Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCT05672251)
    Phase 2
    City of Hope Medical Center
    Recruiting
    Last update posted :
    01/30/2024
    Initiation :
    01/02/2024
    Primary completion :
    12/28/2024
    Completion :
    12/28/2024
    CD20
    |
    CD20 positive
    |
    Zynlonta (loncastuximab tesirine-lpyl) • Lunsumio (mosunetuzumab-axgb)
    Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML (GO-TAG) (NCT05716009)
    Phase 1
    Sidney Kimmel Comprehensive Cancer Center at Jo...
    Recruiting
    Last update posted :
    01/30/2024
    Initiation :
    11/20/2023
    Primary completion :
    12/25/2027
    Completion :
    12/25/2028
    CD33 • IL3RA
    |
    CD123 expression
    |
    Mylotarg (gemtuzumab ozogamicin) • Elzonris (tagraxofusp-erzs)