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    DRUG:

    fludarabine IV

    i
    Other names: NSC 312887
    Company:
    Generic mfg.
    Drug class:
    DNA synthesis inhibitor
    Related drugs:
    21h
    KarMMa-9: A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation (clinicaltrials.gov)
    P3, N=618, Recruiting, Celgene
    New P3 trial
    |
    lenalidomide • cyclophosphamide • fludarabine IV • Abecma (idecabtagene vicleucel)
    21h
    Study Evaluating SC262 in Subjects With r/r B-cell Malignancies (VIVID) (clinicaltrials.gov)
    P1, N=35, Recruiting, Sana Biotechnology | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    cyclophosphamide • fludarabine IV
    24h
    Anti-BCMA Chimeric Antigen Receptor T Cells for Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=5, Active, not recruiting, Thomas Martin, MD | Recruiting --> Active, not recruiting | N=24 --> 5
    Enrollment closed • Enrollment change • CAR T-Cell Therapy
    |
    cyclophosphamide • fludarabine IV
    2d
    Fludarabine, cyclophosphamide, and rituximab as first-line treatment in patients with chronic lymphocytic leukemia: A long-term analysis of the German CLL Study Group (GCLLSG) registry. (PubMed, Eur J Haematol)
    Median overall survival was not reached with a 5-year survival rate of 92.7%. In summary, first-line FCR was associated with long EFS, especially in patients exhibiting a mutated IGHV status.
    Journal
    |
    IGH (Immunoglobulin Heavy Locus)
    |
    Rituxan (rituximab) • cyclophosphamide • fludarabine IV
    2d
    CAR-T Cell Therapy for Desensitization in Kidney Transplantation (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, National Institute of Allergy and Infectious Diseases (NIAID) | Initiation date: Mar 2024 --> May 2024
    Trial initiation date • CAR T-Cell Therapy
    |
    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)
    |
    cyclophosphamide • fludarabine IV • huCART19
    2d
    Orca-T Following Chemotherapy and Total Marrow and Lymphoid Irradiation for the Treatment of Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia or Myelodysplastic Syndrome (clinicaltrials.gov)
    P1, N=33, Recruiting, City of Hope Medical Center | Initiation date: Mar 2024 --> Sep 2024
    Trial initiation date
    |
    melphalan • fludarabine IV • thiotepa • Orca-T
    3d
    CART-BCMA/CS1 in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov)
    P1, N=0, Withdrawn, Jonsson Comprehensive Cancer Center | N=30 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal • IO biomarker
    |
    CD38 positive
    |
    cyclophosphamide • fludarabine IV • CART-BCMA/CS1
    3d
    Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant (clinicaltrials.gov)
    P1/2, N=25, Recruiting, M.D. Anderson Cancer Center | N=40 --> 25 | Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Enrollment change • Trial completion date • Trial primary completion date • Post-transplantation
    |
    Rituxan (rituximab) • cyclophosphamide • bendamustine • melphalan • fludarabine IV • Neupogen (filgrastim)
    3d
    A Clinical Research About CD70-targeted CAR-NKT Cells Therapy Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=12, Recruiting, Fudan University
    New P1 trial • Metastases
    |
    CD70 (CD70 Molecule)
    |
    cyclophosphamide • fludarabine IV
    3d
    In vitro study of cold atmospheric plasma-activated liquids inhibits malignant melanoma by affecting macrophage polarization through the ROS/JAK2/STAT1 pathway. (PubMed, Biomed Pharmacother)
    To test the hypothesis, we employed catalase and fludarabine to block different sites of the pathway...This study illustrates that PAL therapy is an effective tumor immunotherapy and expands the scope of tumor immunotherapy. Furthermore, these findings establish a theoretical foundation for potential clinical applications of PAL.
    Preclinical • Journal
    |
    CAT (Catalase)
    |
    fludarabine IV
    4d
    Dose-escalating Trial With Allo-RevCAR01-T Cells in Combination With CD123 Target Module (R-TM123) for Participants With Selected Hematologic Malignancies Positive for CD123 (clinicaltrials.gov)
    P1, N=37, Recruiting, AvenCell Europe GmbH | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Dec 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    CD123 expression
    |
    cyclophosphamide • fludarabine IV • AVC-201
    5d
    PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=14, Active, not recruiting, City of Hope Medical Center | Trial completion date: Mar 2024 --> Dec 2024
    Trial completion date • CAR T-Cell Therapy • Metastases
    |
    PSCA (Prostate Stem Cell Antigen 2)
    |
    cyclophosphamide • fludarabine IV • MB-105
    5d
    Hematopoietic Stem Cell Transplant for Sickle Cell Disease (clinicaltrials.gov)
    P1, N=4, Completed, Case Comprehensive Cancer Center | Phase classification: P1/2 --> P1 | N=25 --> 4
    Phase classification • Enrollment change
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    fludarabine IV
    5d
    CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=24, Recruiting, Marcela V. Maus, M.D.,Ph.D. | Trial completion date: Oct 2027 --> Jan 2028 | Trial primary completion date: Oct 2025 --> Jan 2027
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy
    |
    CD79B (CD79b Molecule)
    |
    cyclophosphamide • fludarabine IV
    6d
    Persistent Cytopenia After CD19 CAR T Therapy in Relapsed/Refractory DLBCL Patients Could Be a Predictor of Efficacy and Side Effects. (PubMed, Cell Transplant)
    Patients received lymphodepleting chemotherapy with fludarabine and cyclophosphamide before CAR T cell therapy. Progression-free and overall survival were higher in patients with Grades 3-4 persistent cytopenia than in those without cytopenia. Therefore, persistent cytopenia after anti-CD19 CAR T cell therapy in patients with R/R DLBCL can predict therapeutic efficacy and AEs, allowing clinicians to determine the efficiency of CD-19 CAR T cell therapy and the associated AEs.
    Journal • Adverse events
    |
    IL6 (Interleukin 6)
    |
    cyclophosphamide • fludarabine IV
    8d
    Efficacy and Safety of MTBF Conditioning Regimen for Salvageable Allo-HSCT in the Treatment of R/R AML (clinicaltrials.gov)
    P=N/A, N=37, Not yet recruiting, First Affiliated Hospital Xi'an Jiaotong University
    New trial
    |
    fludarabine IV • thiotepa • busulfan • Duoenda (mitoxantrone liposomal)
    8d
    CART-PSMA-TGFβRDN Cells for Castrate-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=23, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    TGFB1 (Transforming Growth Factor Beta 1)
    |
    FOLH1 expression
    |
    cyclophosphamide • fludarabine IV • CART-PSMA- TGFβRDN cells
    9d
    NCI-2018-01607: Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant (clinicaltrials.gov)
    P1/2, N=74, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    FLT3 positive
    |
    sorafenib • cyclophosphamide • fludarabine IV • busulfan • Neupogen (filgrastim)
    9d
    Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies (clinicaltrials.gov)
    P1/2, N=54, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    cyclophosphamide • decitabine • fludarabine IV
    9d
    IGNYTE-ESO: Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (clinicaltrials.gov)
    P2, N=103, Active, not recruiting, Adaptimmune | Trial primary completion date: Nov 2022 --> Aug 2024
    Trial primary completion date • Combination therapy
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • CTAG1B (Cancer/testis antigen 1B)
    |
    HLA-A*02:01 • HLA-A*02 • CTAG1B expression • HLA-A2 positive
    |
    cyclophosphamide • fludarabine IV • letetresgene autoleucel (GSK3377794)
    9d
    A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML) (clinicaltrials.gov)
    P1/2, N=97, Recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Sep 2026 --> Jul 2031 | Trial primary completion date: Nov 2024 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    cytarabine • Xospata (gilteritinib) • fludarabine IV
    9d
    Long-term remission and survival in patients with relapsed or refractory multiple myeloma after treatment with LCAR-B38M CAR T cells: 5-year follow-up of the LEGEND-2 trial. (PubMed, J Hematol Oncol)
    These data, representing the longest follow-up of BCMA-redirected CAR T-cell therapy to date, demonstrate long-term remission and survival with LCAR-B38M for advanced myeloma.
    Journal • CAR T-Cell Therapy
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    cyclophosphamide • fludarabine IV • Carvykti (ciltacabtagene autoleucel)
    9d
    Autologous HER2-specific CAR T cells after lymphodepletion for advanced sarcoma: a phase 1 trial. (PubMed, Nat Cancer)
    In this prospective, interventional phase 1 study for individuals with advanced sarcoma, we infused autologous HER2-specific chimeric antigen receptor T cells (HER2 CAR T cells) after lymphodepletion with fludarabine (Flu) ± cyclophosphamide (Cy): 1 × 108 T cells per m2 after Flu (cohort A) or Flu/Cy (cohort B) and 1 × 108 CAR+ T cells per m2 after Flu/Cy (cohort C). Our results affirm HER2 as a CAR T cell target and demonstrate the safety of this therapeutic approach in sarcoma. ClinicalTrials.gov registration: NCT00902044 .
    P1 data • Journal • CAR T-Cell Therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    cyclophosphamide • fludarabine IV
    10d
    Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances (clinicaltrials.gov)
    P1/2, N=48, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD5 (CD5 Molecule)
    |
    cyclophosphamide • fludarabine IV
    11d
    Dose-escalating Trial With UniCAR02-T Cells and PSMA Target Module (TMpPSMA) in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSMA Marker (clinicaltrials.gov)
    P1, N=16, Terminated, AvenCell Europe GmbH | N=51 --> 16 | Trial completion date: Jul 2025 --> Mar 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Mar 2024; Although IMP has been well tolerated, biological activity was very limited. The sponsor concluded that continued development of IMP would be unlikely to result in meaningful clinical benefit for patients with prostate cancer.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    cyclophosphamide • fludarabine IV
    11d
    Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC (clinicaltrials.gov)
    P1/2, N=33, Recruiting, UNC Lineberger Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open • CAR T-Cell Therapy
    |
    CSPG4 (Chondroitin Sulfate Proteoglycan 4)
    |
    cyclophosphamide • fludarabine IV
    12d
    Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers (clinicaltrials.gov)
    P2, N=10, Recruiting, Fred Hutchinson Cancer Center | Trial primary completion date: Dec 2024 --> Jun 2024
    Trial primary completion date
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • thiotepa • dilanubicel (DVX101)
    12d
    A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL) (clinicaltrials.gov)
    P1/2, N=20, Completed, Celgene | Recruiting --> Completed | N=121 --> 20 | Trial completion date: Dec 2024 --> Jan 2024 | Trial primary completion date: Dec 2024 --> Jan 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    CD19 (CD19 Molecule)
    |
    CD19 expression
    |
    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV
    15d
    A Phase 1 Study of ADI-001 in Lupus Nephritis (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Adicet Bio, Inc
    New P1 trial
    |
    cyclophosphamide • fludarabine IV • ADI-001
    15d
    A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD) (clinicaltrials.gov)
    P1, N=15, Suspended, M.D. Anderson Cancer Center | Recruiting --> Suspended
    Trial suspension • Combination therapy • Minimal residual disease
    |
    Erbitux (cetuximab) • cyclophosphamide • fludarabine IV
    15d
    Ziftomenib in Combination With Chemotherapy for Children With Relapsed/Refractory Acute Leukemia (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, LLS PedAL Initiative, LLC
    New P1 trial • Combination therapy
    |
    cytarabine • ziftomenib (KO-539) • fludarabine IV
    15d
    Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    16d
    A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    TP53 (Tumor protein P53) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CD34 (CD34 molecule) • CD4 (CD4 Molecule)
    |
    TP53 mutation
    |
    cyclophosphamide • melphalan • fludarabine IV • thiotepa • busulfan
    16d
    Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells (clinicaltrials.gov)
    P1, N=20, Recruiting, Hideho Okada, MD, PhD | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV
    16d
    A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus (clinicaltrials.gov)
    P1, N=12, Recruiting, EdiGene Inc.
    New P1 trial
    |
    IFNG (Interferon, gamma) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    cyclophosphamide • fludarabine IV • ATHENA CAR-T
    16d
    A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Kyverna Therapeutics | Phase classification: P1 --> P1/2 | N=12 --> 32
    Phase classification • Enrollment change • CAR T-Cell Therapy
    |
    cyclophosphamide • fludarabine IV
    17d
    Boosting Clear Cell Renal Carcinoma-Specific Drug Discovery Using a Deep Learning Algorithm and Single-Cell Analysis. (PubMed, Int J Mol Sci)
    Finally, five compounds were obtained, including two FDA-approved drugs (flufenamic acid and fludarabine), one endogenous metabolite, one immunology/inflammation-related compound, and one inhibitor of DNA methyltransferase (N4-methylcytidine, a cytosine nucleoside analogue that, like zebularine, has the mechanism of inhibiting DNA methyltransferase). Based on the tumor microenvironment characteristics of ccRCC, five ccRCC-specific compounds were identified, which would give direction of the clinical treatment for ccRCC patients.
    Journal
    |
    EPAS1 (Endothelial PAS domain protein 1)
    |
    fludarabine IV
    17d
    Lentivirally Redirected CD123 Autologous T Cells in AML (clinicaltrials.gov)
    P1, N=12, Recruiting, University of Pennsylvania | Active, not recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • fludarabine IV • CART123
    18d
    A Global Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL. (clinicaltrials.gov)
    P3, N=344, Recruiting, Ascentage Pharma Group Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    Rituxan (rituximab) • cyclophosphamide • Calquence (acalabrutinib) • Leukeran (chlorambucil) • lisaftoclax (APG-2575) • fludarabine IV
    18d
    Clinical Trial of ssCART-19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia (Including Central Nervous System Infiltration) (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
    New P2 trial
    |
    CD19 positive
    |
    cyclophosphamide • fludarabine IV • humanized CD19 CAR-T cells
    19d
    Anti-CD19 Chimeric Antigen Receptor T-Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1/2, N=66, Not yet recruiting, National Cancer Institute (NCI)
    New P1/2 trial • CAR T-Cell Therapy
    |
    CD19 expression
    |
    Rituxan (rituximab) • cyclophosphamide • fludarabine IV
    21d
    FLAG/FLAG-Ida Regimen in Secondary and Relapsed/Refractory Acute Myeloid Leukemia-Even in the Era of New Treatment Modalities Still a Significant Player. (PubMed, J Clin Med)
    The aim of the study was to assess the efficacy and toxicity of fludarabine, cytarabine, and granulocyte-colony stimulation factor (FLAG) with or without idarubicin (-Ida) and to discuss novel therapies in this setting. Among the variables, including age, FLT3 mutation status, European LeukemiaNet (ELN) 2022 classification risk, FLAG vs. FLAG-Ida, and aHSCT, a multivariate analysis revealed that only aHSCT significantly influenced overall survival. (4) FLAG(-Ida) chemotherapy remains an effective salvage chemotherapy for patients with r/r and secondary AML with a plan of proceeding to aHSCT.
    Journal
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3 mutation
    |
    cytarabine • idarubicin hydrochloride • fludarabine IV