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

Optimized Donor Selection, Nonmyeloablative BMT for B-cell Lymphomas With Post-transplantation Cy and Rituximab

Phase 2

Terminated

Conditions: Lymphoma
B-cell Lymphoma
Non Hodgkin Lymphoma
Chronic Lymphocytic Leukemia

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Radiation: Total body irradiation
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
Drug: Rituximab
Biological: Allogeneic Bone Marrow Transplant (BMT)

First Posted Date: 2009-07-24

Last Posted Date: 2018-08-27

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 135

Registration Number: NCT00946023

Locations: 🇺🇸
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

Minor Histocompatibility Vaccination After Allogeneic Stem Cell Transplantation for Advanced Hematologic Malignancies

Phase 1

Terminated

Conditions: Preleukemia
Myeloproliferative Disorders
Lymphoma
Myeloma
Graft Versus Host Disease

Interventions: Drug: Fludarabine
Drug: Melphalan
Drug: Campath

First Posted Date: 2009-07-22

Last Posted Date: 2014-03-17

Lead Sponsor: University of Chicago

Target Recruit Count: 1

Registration Number: NCT00943293

Locations: 🇺🇸
The Uniiversity of Chicago, Chicago, Illinois, United States

Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

Phase 1

Completed

Conditions: Lymphoma
Leukemia
Myeloma

Interventions: Drug: Busulfan
Drug: Fludarabine
Drug: Campath
Procedure: Stem Cell Transplant

First Posted Date: 2009-07-22

Last Posted Date: 2019-02-04

Lead Sponsor: University of Chicago

Target Recruit Count: 50

Registration Number: NCT00943319

Locations: 🇺🇸
The University of Chicago, Chicago, Illinois, United States

Haploidentical Natural Killer (NK) Cells With Epratuzumab for Relapsed Acute Lymphoblastic Leukemia (ALL)

Phase 2

Terminated

Conditions: Leukemia
Pediatric Cancer

Interventions: Drug: Epratuzumab
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Mesna
Procedure: Infusion of NK cells
Drug: Interleukin-2

First Posted Date: 2009-07-20

Last Posted Date: 2014-05-22

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 2

Registration Number: NCT00941928

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Phase 1/2 Study of Metastatic Renal Cancer Using T-Cells Transduced With a T-Cell Receptor Which Recognizes TRAIL Bound to the DR4 Receptor

Phase 1

Terminated

Conditions: Renal Cancer
Kidney Cancer

First Posted Date: 2009-06-18

Last Posted Date: 2019-04-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 5

Registration Number: NCT00923390

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Phase II Trial of LMB-2, Fludarabine and Cyclophosphamide for Adult T-Cell Leukemia

Phase 1

Completed

Conditions: Adult T-Cell Leukemia (ATL)

Interventions: Drug: LMB-2
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2009-06-18

Last Posted Date: 2023-11-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 18

Registration Number: NCT00924170

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Chemotherapy Followed by Infusion of DMF5 Cells to Treat Metastatic Melanoma

Phase 1

Terminated

Conditions: Melanoma
Malignant Melanoma
Melanoma, Experimental

Interventions: Drug: DMF5 Melanoma Reactive TIL
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Aldesleukin

First Posted Date: 2009-06-18

Last Posted Date: 2012-10-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT00924001

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

CAR T Cell Receptor Immunotherapy for Patients With B-cell Lymphoma

Phase 1

Completed

Conditions: Diffuse, Large B-cell Lymphoma
Mantle Cell
Primary Mediastinal B-cell Lymphoma
Diffuse Large B-Cell Lymphoma Transformed From Follicular Lymphoma

Interventions: Biological: Anti-cluster of differentiation 19 (CD19)-CAR PBL
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Aldesleukin

First Posted Date: 2009-06-18

Last Posted Date: 2022-01-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 43

Registration Number: NCT00924326

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Radiation, Chemotherapy, Vaccine and Anti-MART-1 and Anti-gp100 Cells for Patients With Metastatic Melanoma

Phase 2

Completed

Conditions: Skin Cancer
Melanoma

Interventions: Drug: Montanide ISA 51 VG
Procedure: Radiation
Drug: Aldesleukin
Drug: Fludarabine
Drug: Cyclophosphamide
Genetic: Anti-MART-1 F5 TCR PBL

First Posted Date: 2009-06-18

Last Posted Date: 2015-10-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 4

Registration Number: NCT00923195

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer

Phase 1

Terminated

Conditions: Metastatic Cancer

Interventions: Drug: in vitro tumor reactive, chimeric T cell receptor (CAR ) gene-transduced PBL plus IV aldesleukin
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Mesna

First Posted Date: 2009-06-18

Last Posted Date: 2015-10-28

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT00924287

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Drug Development Updates

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