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

Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017

Phase 3

Recruiting

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Interventions: Drug: Bortezomib
Drug: Blinatumomab
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Daunorubicin
Drug: Dexamethasone
Drug: Myocet
Drug: Doxorubicin
Drug: 6-Mercaptopurine
Drug: Etoposide
Drug: Fludarabine Phosphate
Drug: Prednisolone
Drug: Ifosfamide
Drug: Tioguanin
Drug: Pegaspargase
Drug: Methotrexate
Drug: Erwinase
Drug: Vincristine
Drug: Vindesine

First Posted Date: 2018-08-22

Last Posted Date: 2023-11-29

Lead Sponsor: Martin Schrappe

Target Recruit Count: 5000

Registration Number: NCT03643276

Locations: 🇮🇹
AOUC Policlinico Bari, Bari, Italy
🇮🇹
A.O. Papa Giovanni XXIII, Bergamo, Italy
🇮🇹
S.O. Annunziata - A. O. Cosenza, Cosenza, Italy

and more 111 locations

Cytokine-Treated Veto Cells in Treating Patients With Hematologic Malignancies Following Stem Cell Transplant

Phase 1

Recruiting

Conditions: Aplastic Anemia
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Mantle Cell Lymphoma
Plasma Cell Myeloma
Chronic Lymphocytic Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Bone Marrow Failure
Follicular Lymphoma
Hodgkin Lymphoma

Interventions: Biological: Anti-Thymocyte Globulin
Drug: Cyclophosphamide
Biological: Cytokine-treated Veto Cells
Drug: Fludarabine
Procedure: Peripheral Blood Stem Cell Transplantation
Radiation: Total-Body Irradiation

First Posted Date: 2018-08-09

Last Posted Date: 2024-08-02

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT03622788

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

Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Phase 1

Terminated

Conditions: Relapsed/Refractory Chronic Lymphocytic Leukemia and Relapsed/Refractory Small Lymphocytic Lymphoma

Interventions: Biological: brexucabtagene autoleucel
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2018-08-09

Last Posted Date: 2023-11-18

Lead Sponsor: Kite, A Gilead Company

Target Recruit Count: 16

Registration Number: NCT03624036

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇮🇹
IRCCS Ospedale San Raffaele, Milano, Italy
🇺🇸
Emory University, Atlanta, Georgia, United States

and more 19 locations

Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors

Phase 2

Terminated

Conditions: Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Acute Lymphoid Leukemia (ALL)
Chronic Myeloid Leukemia (CML)
Hodgkin Lymphoma
Acute Myeloid Leukemia (AML)

Interventions: Radiation: Hyperfractionated total body irradiation
Drug: Busulfan
Drug: Thiotepa
Drug: Fludarabine
Drug: Melphalan
Drug: Cyclophosphamide
Drug: Clofarabine
Procedure: HPC(A) stem cell allograft
Drug: Rituximab
Device: Rabbit antithymocyte globulin

First Posted Date: 2018-08-03

Last Posted Date: 2024-03-12

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 9

Registration Number: NCT03615105

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia (AML)
MDS/Myeloproliferative Neoplasm-unclassifiable (MDS/MPN-unclassifiable)
Myelodysplastic Syndrome (MDS)
Hematopoietic Stem Cell Transplant
Chronic Myelomonocytic Leukemia (CMML)

Interventions: Drug: Venetoclax
Drug: Fludarabine
Drug: Busulfan
Drug: Azacitidine
Drug: Decitabine/cedazuridine

First Posted Date: 2018-08-03

Last Posted Date: 2024-01-26

Lead Sponsor: Jacqueline Garcia, MD

Target Recruit Count: 100

Registration Number: NCT03613532

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

TCR Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors

Phase 2

Terminated

Conditions: Non-Malignant Hematologic Disorders

Interventions: Drug: Melphalan
Drug: Thiotepa
Drug: Clofarabine
Drug: Fludarabine
Drug: Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®)
Procedure: CliniMACS reagents

First Posted Date: 2018-08-03

Last Posted Date: 2021-03-24

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 1

Registration Number: NCT03615144

Locations: 🇺🇸
Memorial SloanKettering Cancer Center, New York, New York, United States

Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma

Phase 2

Terminated

Conditions: Platinum-Resistant Ovarian Carcinoma
Recurrent High Grade Ovarian Serous Adenocarcinoma
Refractory Colorectal Carcinoma
Malignant Solid Neoplasm
Metastatic Colorectal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Stage IV Colorectal Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Metastatic Ovarian Carcinoma
Recurrent Ovarian Carcinosarcoma

Interventions: Biological: Autologous Tumor Infiltrating Lymphocytes MDA-TIL
Drug: Cyclophosphamide
Drug: Fludarabine
Biological: Interleukin-2
Other: Quality-of-Life Assessment

First Posted Date: 2018-08-01

Last Posted Date: 2024-08-26

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 60

Registration Number: NCT03610490

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

Comparing ATG or Post-Transplant Cyclophosphamide to Calcineurin Inhibitor-Methotrexate as GVHD Prophylaxis After Myeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation

Phase 2

Withdrawn

Conditions: Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome
Myelofibrosis
Recurrent Hodgkin Lymphoma
Therapy-Related Acute Myeloid Leukemia
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Hematopoietic and Lymphoid System Neoplasm
Acute Lymphoblastic Leukemia in Remission
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Recurrent Non-Hodgkin Lymphoma

Interventions: Biological: Anti-Thymocyte Globulin
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Cyclosporine
Drug: Fludarabine Phosphate
Drug: Methotrexate
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Quality-of-Life Assessment
Other: Questionnaire Administration
Drug: Tacrolimus
Radiation: Total-Body Irradiation

First Posted Date: 2018-07-27

Last Posted Date: 2021-06-30

Lead Sponsor: Fred Hutchinson Cancer Center

Registration Number: NCT03602898

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

T Cells Expressing a Novel Fully-Human Anti-BCMA CAR for Treating Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Myeloma-Multiple
Myeloma, Plasma-Cell

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Biological: Anti-B Cell Maturation Antigen (BCMA) chimeric antigen receptors (CARs) T cells

First Posted Date: 2018-07-27

Last Posted Date: 2024-11-26

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT03602612

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

Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL

Phase 1

Recruiting

Conditions: Neoplasms
Cutaneous Lymphoma
Lymphoproliferative Disorders
Lymphomatoid Papulosis
Cutaneous T Cell Lymphoma
Immunoproliferative Disorders
Cutaneous Anaplastic Large Cell Lymphoma
Lymphatic Diseases
Mycosis Fungoides
Sezary Syndrome

Interventions: Biological: ATLCAR.CD30.CCR4 cells
Biological: ALTCAR.CD30 cells
Drug: Bendamustine
Drug: Fludarabine

First Posted Date: 2018-07-26

Last Posted Date: 2024-10-26

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 59

Registration Number: NCT03602157

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

Drug Development Updates

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