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    DRUG:

    fludarabine IV

    i
    Other names: NSC 312887, NSC-312887, NSC312887
    Company:
    Generic mfg.
    Drug class:
    DNA synthesis inhibitor
    Related drugs:
    1d
    Allogeneic CD19-targeted CAR-γδT Cell Infusion Therapy in Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1, N=18, Recruiting, The First Affiliated Hospital of Soochow University
    New P1 trial
    |
    cyclophosphamide • fludarabine IV
    3d
    BRAVO: Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I) (clinicaltrials.gov)
    P1, N=21, Active, not recruiting, University of Florida | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    temozolomide • cyclophosphamide • fludarabine IV
    3d
    NCI-2017-02205: Infusion of Expanded Cord Blood Cells in Addition to Single Cord Blood Transplant in Treating Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplastic Syndromes (clinicaltrials.gov)
    P2, N=35, Recruiting, Fred Hutchinson Cancer Center | N=20 --> 35 | Trial completion date: Oct 2026 --> Mar 2027 | Trial primary completion date: Dec 2024 --> Mar 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CD34 (CD34 molecule) • HLA-B (Major Histocompatibility Complex, Class I, B)
    |
    cyclophosphamide • fludarabine IV • thiotepa • dilanubicel (DVX101)
    4d
    Gene and Vaccine Therapy in Treating Patients With Advanced Malignancies (clinicaltrials.gov)
    P2, N=6, Active, not recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Nov 2025 --> Nov 2026 | Trial primary completion date: Nov 2024 --> Nov 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    CTAG1B (Cancer/testis antigen 1B)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    6d
    Succinate dehydrogenase deficiency-driven succinate accumulation induces drug resistance in acute myeloid leukemia via ubiquitin-cullin regulation. (PubMed, Nat Commun)
    Notably, decreasing succinate by fludarabine can restore the sensitivity of anti-cancer drugs in SDH-deficient AML. Together, we uncover the function of succinate in driving drug resistance by regulating p-UBC12/cullin activity, and indicate reshaping succinate metabolism as a promising treatment for SDH-deficient AML.
    Journal
    |
    UBE2M (Ubiquitin Conjugating Enzyme E2 M)
    |
    fludarabine IV
    10d
    Study Evaluating SC262 in Subjects With r/r Non-Hodgkin's Lymphoma (VIVID) (clinicaltrials.gov)
    P1, N=35, Recruiting, Sana Biotechnology | Initiation date: Oct 2024 --> Apr 2024
    Trial initiation date
    |
    cyclophosphamide • fludarabine IV
    10d
    LOKI: Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah (clinicaltrials.gov)
    P1, N=0, Withdrawn, University Health Network, Toronto | N=40 --> 0 | Recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    cyclophosphamide • Kymriah (tisagenlecleucel-T) • fludarabine IV
    10d
    Study Evaluating SC291 in Subjects With r/r B-cell Malignancies (ARDENT) (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, Sana Biotechnology | Recruiting --> Active, not recruiting | N=57 --> 16 | Trial completion date: Dec 2027 --> Nov 2038 | Trial primary completion date: Dec 2026 --> Nov 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • CAR T-Cell Therapy • IO biomarker
    |
    cyclophosphamide • fludarabine IV • SC291
    10d
    Haploidentical Stem Cell Transplant with Prophylactic Natural Killer DLI for Lymphoma, Multiple Myeloma, and CLL (clinicaltrials.gov)
    P1, N=20, Completed, Noah Merin | Active, not recruiting --> Completed | N=30 --> 20 | Trial completion date: Nov 2031 --> Nov 2024
    Trial completion • Enrollment change • Trial completion date
    |
    MYC (V-myc avian myelocytomatosis viral oncogene homolog) • CD20 (Membrane Spanning 4-Domains A1) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • CD4 (CD4 Molecule) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B)
    |
    Chr del(17p) • Chr del(11q) • Chr t(4;14) • Chr t(14;16) • CD20 expression
    |
    Rituxan (rituximab) • bendamustine • fludarabine IV
    12d
    A novel myeloablative pretreatment scheme for single arm, single center, exploratory study of umbilical cord blood transplantation (ChiCTR2400090099)
    P=N/A, N=30, Not yet recruiting, The Seventh Affiliated Hospital Sun Yat-sen University; The?Seventh?Affiliated?Hospital?Sun?Yat-sen?University
    New trial
    |
    cyclophosphamide • fludarabine IV
    15d
    Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood (clinicaltrials.gov)
    P1/2, N=65, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    FLT3 (Fms-related tyrosine kinase 3)
    |
    FLT3-ITD mutation
    |
    cytarabine • etoposide IV • Vanflyta (quizartinib) • fludarabine IV
    15d
    IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multiple Sclerosis (clinicaltrials.gov)
    P1, N=34, Not yet recruiting, Indapta Therapeutics, INC.
    New P1 trial
    |
    IL2 (Interleukin 2)
    |
    cyclophosphamide • fludarabine IV • mesna • IDP-023 • Proleukin (aldesleukin) • Ocrevus (ocrelizumab)
    15d
    NAT10-mediated mRNA N4-acetylcytidine reprograms serine metabolism to drive leukaemogenesis and stemness in acute myeloid leukaemia. (PubMed, Nat Cell Biol)
    We further characterize fludarabine as an inhibitor of NAT10 and demonstrate that pharmacological inhibition of NAT10 targets serine metabolic vulnerability, triggering substantial anti-leukaemia effects both in vitro and in vivo. Collectively, our study demonstrates the functional importance of ac4C and NAT10 in metabolism control and leukaemogenesis, providing insights into the potential of targeting NAT10 for AML therapy.
    Journal
    |
    HOXA9 (Homeobox A9)
    |
    fludarabine IV
    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
    |
    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)
    |
    TP53 mutation • CD22 expression • IKZF1 mutation • KMT2A mutation • MLL mutation
    |
    clonoSEQ
    |
    Rituxan (rituximab) • Iclusig (ponatinib) • cyclophosphamide • Blincyto (blinatumomab) • methotrexate • Besponsa (inotuzumab ozogamicin) • bendamustine • melphalan • fludarabine IV
    16d
    A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL (clinicaltrials.gov)
    P1/2, N=32, Active, not recruiting, Dana-Farber Cancer Institute | Phase classification: P1b/2 --> P1/2
    Phase classification • Combination therapy
    |
    Rituxan (rituximab) • cyclophosphamide • Copiktra (duvelisib) • fludarabine IV
    16d
    Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=3, Terminated, Institute of Hematology & Blood Diseases Hospital, China | N=18 --> 3 | Recruiting --> Terminated; It did not reach the expected results of clinical trial
    Enrollment change • Trial termination
    |
    CD33 (CD33 Molecule)
    |
    CD33 positive
    |
    cytarabine • fludarabine IV • QN-023a
    16d
    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: Sep 2024 --> May 2024
    Trial initiation date
    |
    melphalan • fludarabine IV • thiotepa • Orca-T
    16d
    Natural Killer(NK) Cell Therapy for AML Minimal Residual Disease (clinicaltrials.gov)
    P1, N=1, Terminated, Institute of Hematology & Blood Diseases Hospital, China | N=18 --> 1 | Recruiting --> Terminated; It did not reach the expected results of clinical trial
    Enrollment change • Trial termination • Minimal residual disease
    |
    cytarabine • fludarabine IV
    17d
    Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • CAR T-Cell Therapy • Metastases • Immune cell
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600 • CD123 expression
    |
    cyclophosphamide • fludarabine IV • MB-101
    17d
    BAH248: Biological Tumor Infiltrating Lymphocytes Therapy With Immunotherapy for Colon and Rectum Cancer (clinicaltrials.gov)
    P1/2, N=85, Recruiting, Essen Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV
    17d
    BAH2472: TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas (clinicaltrials.gov)
    P1/2, N=85, Recruiting, Essen Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV
    18d
    Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases (clinicaltrials.gov)
    P=N/A, N=200, Recruiting, Masonic Cancer Center, University of Minnesota | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    KMT2A (Lysine Methyltransferase 2A) • IKZF1 (IKAROS Family Zinc Finger 1)
    |
    MLL rearrangement • MLL rearrangement
    |
    cyclophosphamide • fludarabine IV • cyclosporin A microemulsion
    22d
    Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Gruppo Italiano Malattie EMatologiche dell'Adulto
    New P2 trial • Combination therapy
    |
    cytarabine • Xospata (gilteritinib) • idarubicin hydrochloride • fludarabine IV
    22d
    Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases (clinicaltrials.gov)
    P2/3, N=38, Completed, Columbia University | Unknown status --> Completed
    Trial completion
    |
    cyclophosphamide • Campath (alemtuzumab) • fludarabine IV • busulfan
    23d
    Evaluation of CD19-Specific CAR Engineered Autologous T-Cells for Treatment of Relapsed/Refractory CD19+ Acute Lymphoblastic Leukemia (clinicaltrials.gov)
    P1/2, N=24, Active, not recruiting, St. Jude Children's Research Hospital | Trial completion date: Jul 2024 --> Jul 2025
    Trial completion date
    |
    CD19 expression
    |
    cyclophosphamide • fludarabine IV • mesna • SJCAR19
    23d
    Combination Chemotherapy, Total Body Irradiation, and Donor Blood Stem Cell Transplant in Treating Patients With Secondary Myelofibrosis (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=16 --> 22
    Enrollment closed • Enrollment change • Metastases • Post-transplantation
    |
    cyclophosphamide • melphalan • fludarabine IV
    24d
    Romidepsin Maintenance After Allogeneic Stem Cell Transplantation (clinicaltrials.gov)
    P1, N=23, Active, not recruiting, Ohio State University Comprehensive Cancer Center | Recruiting --> Active, not recruiting | N=10 --> 23 | Trial completion date: Dec 2022 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2024
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date
    |
    HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
    |
    Istodax (romidepsin) • fludarabine IV • busulfan
    24d
    Phase 1 Study of ROR1 Specific CAR T Cells in Advanced Hematopoietic and Epithelial Malignancies. (PubMed, Clin Cancer Res)
    ROR1 CAR T cells were well tolerated in most patients. Antitumor activity was observed in CLL but was limited in TNBC and NSCLC. Immunogenicity of the CAR and lack of sustained tumor infiltration were identified as limitations.
    P1 data • Journal • CAR T-Cell Therapy • Metastases
    |
    ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
    |
    ROR1 expression
    |
    cyclophosphamide • oxaliplatin • fludarabine IV
    25d
    Adoptive Cell Therapy Across Cancer Diagnoses (clinicaltrials.gov)
    P1/2, N=25, Completed, Inge Marie Svane | Unknown status --> Completed
    Trial completion
    |
    IL2 (Interleukin 2)
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    25d
    ZUMA-4: Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=95, Active, not recruiting, Kite, A Gilead Company | Trial primary completion date: Mar 2026 --> Sep 2024
    Trial primary completion date
    |
    CD20 negative
    |
    cyclophosphamide • fludarabine IV • Tecartus (brexucabtagene autoleucel)
    25d
    Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel) (clinicaltrials.gov)
    P1, N=39, Not yet recruiting, M.D. Anderson Cancer Center
    New P1 trial
    |
    cyclophosphamide • fludarabine IV
    25d
    Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P1, N=9, Active, not recruiting, Fred Hutchinson Cancer Center | Recruiting --> Active, not recruiting | N=15 --> 9
    Enrollment closed • Enrollment change
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MSLN (Mesothelin)
    |
    MSLN expression • HLA-A*02
    |
    cyclophosphamide • bendamustine • fludarabine IV • FH-TCR-Tᴍsʟɴ
    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
    |
    CD22 (CD22 Molecule)
    |
    CD22 positive • CD22 expression • CD22 overexpression
    |
    cytarabine • bortezomib • Blincyto (blinatumomab) • Besponsa (inotuzumab ozogamicin) • fludarabine IV
    29d
    FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=9, Completed, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Oct 2024 | Active, not recruiting --> Completed
    Trial completion • Trial completion date
    |
    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • CD38 (CD38 Molecule)
    |
    CD38 expression
    |
    cyclophosphamide • fludarabine IV • Darzalex Faspro (daratumumab and hyaluronidase-fihj) • FT538
    29d
    Safety and Efficacy of Repeat Administration of Ad/PNP and Fludarabine Phosphate in Patients With Local Head/Neck Cancer (clinicaltrials.gov)
    P1/2, N=8, Active, not recruiting, GeoVax, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Aug 2025 --> Dec 2024 | Trial primary completion date: May 2024 --> Dec 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    fludarabine IV
    30d
    ALPP CAR-T Cells for ALPP-Positive Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=9, Recruiting, Xinqiao Hospital of Chongqing | Suspended --> Recruiting
    Enrollment open • CAR T-Cell Therapy • Metastases
    |
    cyclophosphamide • fludarabine IV
    1m
    Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma (clinicaltrials.gov)
    P1, N=12, Not yet recruiting, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
    New P1 trial • Metastases
    |
    cyclophosphamide • fludarabine IV
    1m
    Study to Evaluate Safety and Antitumor Activity of Lete-Cel (GSK3377794) in HLA-A2+ Participants With NY-ESO-1 Positive Previously Untreated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma (clinicaltrials.gov)
    P2, N=7, Active, not recruiting, Adaptimmune | Trial completion date: Jul 2024 --> Jul 2025
    Trial completion date • Metastases
    |
    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)
    1m
    Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients with Stage III-IV Melanoma (clinicaltrials.gov)
    P1, N=34, Active, not recruiting, M.D. Anderson Cancer Center | N=15 --> 34 | Trial completion date: Jun 2025 --> Oct 2027 | Trial primary completion date: Jun 2024 --> Oct 2027
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    NGFR (Nerve Growth Factor Receptor) • TGFA (Transforming Growth Factor Alpha)
    |
    cyclophosphamide • fludarabine IV • Proleukin (aldesleukin)
    1m
    Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation (clinicaltrials.gov)
    P=N/A, N=20, Recruiting, Northside Hospital, Inc. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
    Trial completion date • Trial primary completion date
    |
    fludarabine IV
    1m
    BAH250: TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Stomach and Esophageal Cancer (clinicaltrials.gov)
    P1/2, N=75, Recruiting, Essen Biotech | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Keytruda (pembrolizumab) • cyclophosphamide • fludarabine IV
    1m
    TRANSCEND FL: A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) (clinicaltrials.gov)
    P2, N=276, Recruiting, Celgene | Active, not recruiting --> Recruiting
    Enrollment open
    |
    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV