Fludarabine

Generic Name: Fludarabine

Brand Names: Fludara

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₂FN_₅O_₄

CAS Number: 21679-14-1

Unique Ingredient Identifier: P2K93U8740

Background: Fludarabine is a chemotherapeutic agent used in the treatment of hematological malignancies. It is commonly marketed under the brand name Fludara.

Indication: For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen

Associated Conditions: B-cell chronic lymphocytic leukemia/prolymphocytic leukemia/small lymphocytic lymphoma refractory, Refractory Non-Hodgkin's lymphoma

Associated Therapies: -

Clinical Trials

TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy

Phase 1

Terminated

Conditions: Melanoma
Non-small Cell Lung Cancer
Renal Cell Carcinoma
Small-cell Lung Cancer
Cutaneous Squamous Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Urothelial Carcinoma
Anal Squamous Cell Carcinoma
Merkel Cell Carcinoma

Interventions: Biological: GEN-011
Drug: IL-2
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2020-10-22

Last Posted Date: 2022-07-15

Lead Sponsor: Genocea Biosciences, Inc.

Target Recruit Count: 49

Registration Number: NCT04596033

Locations: 🇺🇸
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 5 locations

²¹¹At-OKT10-B10 and Fludarabine Alone or in Combination With Cyclophosphamide and Low-Dose TBI Before Donor Stem Cell Transplant for the Treatment of Newly Diagnosed, Recurrent, or Refractory High-Risk Multiple Myeloma

Phase 1

Not yet recruiting

Conditions: Multiple Myeloma
Recurrent Multiple Myeloma
Refractory Multiple Myeloma

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10
Drug: Fludarabine Phosphate
Drug: Cyclophosphamide
Radiation: Total-Body Irradiation
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: X-Ray Imaging

First Posted Date: 2020-10-08

Last Posted Date: 2024-11-12

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 30

Registration Number: NCT04579523

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

Haploidentical HCT for Severe Aplastic Anemia

Phase 2

Recruiting

Conditions: Aplastic Anemia
Bone Marrow Failure Syndrome

Interventions: Drug: Anti-Thymocyte Globulin (Rabbit)
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mesna
Drug: G-CSF
Radiation: Total Lymphoid Irradiation (TLI)
Device: CliniMACS
Biological: HPC, A Infusion
Biological: CD45RA-depleted DLI

First Posted Date: 2020-09-22

Last Posted Date: 2024-10-16

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 21

Registration Number: NCT04558736

Locations: 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States

FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumor, Adult

Interventions: Drug: FT516
Drug: Avelumab
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: IL-2

First Posted Date: 2020-09-16

Last Posted Date: 2023-09-21

Lead Sponsor: Fate Therapeutics

Target Recruit Count: 12

Registration Number: NCT04551885

Locations: 🇺🇸
University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Hackensack University Medical Center/John Theurer Cancer Center, Hackensack, New Jersey, United States

Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma

Phase 1

Recruiting

Conditions: Diffuse Large B Cell Lymphoma
Refractory Non-Hodgkin Lymphoma
Follicular Lymphoma
Primary Mediastinal Large B Cell Lymphoma
Mantle Cell Lymphoma
Small Lymphocytic Lymphoma
Transformed Lymphoma
Burkitt Lymphoma
Lymphoplasmacytic Lymphoma

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Biological: anti-CD19 CAR-T cells

First Posted Date: 2020-09-11

Last Posted Date: 2023-12-14

Lead Sponsor: C. Babis Andreadis

Target Recruit Count: 36

Registration Number: NCT04545762

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

Testing a New Immune Cell Therapy, GD2-Targeted Modified T-cells (GD2CART), in Children, Adolescents, and Young Adults With Relapsed/Refractory Osteosarcoma and Neuroblastoma, The GD2-CAR PERSIST Trial

Phase 1

Suspended

Conditions: Recurrent Childhood Neuroblastoma
Recurrent Childhood Osteosarcoma
Recurrent Neuroblastoma
Recurrent Osteosarcoma
Refractory Childhood Neuroblastoma
Refractory Childhood Osteosarcoma
Refractory Neuroblastoma
Refractory Osteosarcoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Procedure: Echocardiography
Drug: Fludarabine Phosphate
Biological: GD2-CAR-expressing Autologous T-lymphocytes
Procedure: Imaging Procedure
Procedure: Magnetic Resonance Imaging of the Heart
Procedure: Multigated Acquisition Scan
Other: Questionnaire Administration

First Posted Date: 2020-09-07

Last Posted Date: 2025-01-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 67

Registration Number: NCT04539366

Locations: 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸
Lucile Packard Children's Hospital Stanford University, Palo Alto, California, United States
🇺🇸
Children's Hospital Colorado, Aurora, Colorado, United States

and more 3 locations

Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated or Viral Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab

Phase 2

Withdrawn

Conditions: Metastatic HPV-16 Positive Squamous Cell Anal Cancer

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin
Drug: Pembrolizumab (KEYTRUDA(R))
Biological: Individual Patient TCR-Transduced PBL

First Posted Date: 2020-09-03

Last Posted Date: 2021-02-01

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT04536922

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Donor Stem Cell Transplant After Chemotherapy for the Treatment of Recurrent or Refractory High-Risk Solid Tumors in Pediatric and Adolescent-Young Adults

Phase 2

Terminated

Conditions: Refractory Malignant Peripheral Nerve Sheath Tumor
Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Recurrent Neuroblastoma
Recurrent Rhabdomyosarcoma
Refractory Malignant Solid Neoplasm
Desmoplastic Small Round Cell Tumor
Recurrent Malignant Peripheral Nerve Sheath Tumor
Refractory Desmoplastic Small Round Cell Tumor
Recurrent Desmoplastic Small Round Cell Tumor
Recurrent Malignant Solid Neoplasm

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Cyclosporine
Drug: Etoposide
Drug: Fludarabine Phosphate
Biological: Lapine T-Lymphocyte Immune Globulin
Drug: Melphalan
Drug: Mycophenolate Mofetil
Drug: Tacrolimus
Drug: Thiotepa

First Posted Date: 2020-08-28

Last Posted Date: 2024-10-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 40

Registration Number: NCT04530487

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Fludarabine, Cytarabine, and Pegcrisantaspase for the Treament of Relapsed or Refractory Leukemia

Phase 1

Terminated

Conditions: Recurrent T-Cell Prolymphocytic Leukemia
Recurrent Acute Biphenotypic Leukemia
Refractory Acute Myeloid Leukemia
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Refractory Acute Biphenotypic Leukemia
Refractory T-Cell Prolymphocytic Leukemia
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Acute Lymphoblastic Leukemia
Refractory Acute Lymphoblastic Leukemia
Recurrent Acute Myeloid Leukemia

Interventions: Drug: Cytarabine
Drug: Fludarabine
Drug: Pegcrisantaspase

First Posted Date: 2020-08-26

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 19

Registration Number: NCT04526795

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Master Protocol to Assess Safety and Dose of First Time in Human Next Generation Engineered T Cells in NY-ESO-1 and/or LAGE-1a Positive Advanced Solid Tumors

Phase 1

Terminated

Conditions: Neoplasms

Interventions: Drug: GSK3845097
Drug: GSK3901961
Drug: GSK4427296
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2020-08-25

Last Posted Date: 2024-11-26

Lead Sponsor: Adaptimmune

Target Recruit Count: 12

Registration Number: NCT04526509

Locations: 🇸🇪
GSK Investigational Site, Stockholm, Sweden

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