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

Safety and Efficacy Evaluation of IM19 Cells

Phase 1

Conditions: Hematological Malignancies

Interventions: Biological: IM19 CAR-T
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2017-11-17

Last Posted Date: 2017-11-17

Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Target Recruit Count: 20

Registration Number: NCT03344705

Locations: 🇨🇳
Peking University Third Hospital, Beijing, Beijing, China

Thiotepa Plus Fludarabine+ Melphalan as the Preparative Regime for Alternative Donor Transplantation

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Melphalan
Drug: Thiotepa
Drug: Fludarabine

First Posted Date: 2017-11-14

Last Posted Date: 2025-01-07

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 39

Registration Number: NCT03342196

Locations: 🇺🇸
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Biological: Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143
Drug: Cyclophosphamide
Drug: Fludarabine
Procedure: Leukapheresis

First Posted Date: 2017-11-09

Last Posted Date: 2023-09-08

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 28

Registration Number: NCT03338972

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

Fludarabine Phosphate, Cyclophosphamide, Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Blood Cancer

Phase 2

Active, not recruiting

Conditions: Acute Leukemia in Remission
Acute Myeloid Leukemia
CD40 Ligand Deficiency
Chronic Lymphocytic Leukemia
Glanzmann Thrombasthenia
Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Congenital Pure Red Cell Aplasia
Myelofibrosis
Paroxysmal Nocturnal Hemoglobinuria
Secondary Acute Myeloid Leukemia

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Procedure: Peripheral Blood Stem Cell Transplantation
Radiation: Total-Body Irradiation

First Posted Date: 2017-11-07

Last Posted Date: 2024-04-02

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 31

Registration Number: NCT03333486

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant

Phase 1

Suspended

Conditions: Juvenile Myelomonocytic Leukemia
Recurrent Acute Biphenotypic Leukemia
Recurrent Acute Undifferentiated Leukemia
Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Recurrent Acute Lymphoblastic Leukemia
Recurrent Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Acute Biphenotypic Leukemia

Interventions: Biological: CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR
Drug: Fludarabine
Other: Laboratory Biomarker Analysis

First Posted Date: 2017-10-31

Last Posted Date: 2024-11-15

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 24

Registration Number: NCT03326921

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

A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia

Phase 2

Withdrawn

Conditions: Relapsed/Refractory FLT3-mutated AML

Interventions: Drug: Crenolanib
Drug: Fludarabine
Drug: Cytarabine

First Posted Date: 2017-10-27

Last Posted Date: 2019-01-10

Lead Sponsor: Arog Pharmaceuticals, Inc.

Registration Number: NCT03324243

Study of BCMA CAR-T in Multiple Myeloma

Phase 1

Conditions: Multiple Myeloma

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Biological: BCMA CAR-T

First Posted Date: 2017-10-26

Last Posted Date: 2017-12-29

Lead Sponsor: Henan Cancer Hospital

Target Recruit Count: 10

Registration Number: NCT03322735

Locations: 🇨🇳
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan, China

Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma

Phase 1

Terminated

Conditions: Relapsed/Refractory Multiple Myeloma

Interventions: Genetic: KITE-585
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2017-10-24

Last Posted Date: 2023-10-19

Lead Sponsor: Kite, A Gilead Company

Target Recruit Count: 17

Registration Number: NCT03318861

Locations: 🇺🇸
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
David Geffen School of Medicine at UCLA, Los Angeles, California, United States

and more 6 locations

Allogeneic Stem Cell Transplantation for Multiple Myeloma and Myelofibrosis

Phase 2

Terminated

Conditions: IDH1 Gene Mutation
Plasma Cell Myeloma
Secondary Myelofibrosis
ASXL1 Gene Mutation
EZH2 Gene Mutation
Primary Myelofibrosis
Anemia
IDH2 Gene Mutation
Recurrent Plasma Cell Myeloma
Thrombocytopenia

Interventions: Drug: Busulfan
Drug: Cyclophosphamide
Drug: Fludarabine
Procedure: Hematopoietic Cell Transplantation
Other: Laboratory Biomarker Analysis

First Posted Date: 2017-10-06

Last Posted Date: 2022-05-05

Lead Sponsor: University of Utah

Target Recruit Count: 6

Registration Number: NCT03303950

Locations: 🇺🇸
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant Tumors

Not Applicable

Conditions: B Cell Leukemia
Hepatocellular Carcinoma
Adenocarcinoma of Esophagogastric Junction
B Cell Lymphoma
Myeloma
Pancreatic Carcinoma

Interventions: Genetic: CAR-CD19 T cell
Genetic: CAR-BCMA T cell
Genetic: CAR-GPC3 T cell
Genetic: CAR-CLD18 T cell
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2017-10-05

Last Posted Date: 2020-10-08

Lead Sponsor: Kang YU

Target Recruit Count: 18

Registration Number: NCT03302403

Locations: 🇨🇳
First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China

Drug Development Updates

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