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

Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML

Phase 1

Recruiting

Conditions: Aml
Acute Myeloid Leukemia, Pediatric
Acute Myeloid Leukemia
AML, Childhood

Interventions: Drug: Rabbit Anti thymocyte globulin
Drug: Plerixafor
Biological: Granulocyte Colony-Stimulating Factor
Drug: Busulfan
Drug: Fludarabine
Drug: Thiotepa
Drug: Melphalan
Biological: TCR alpha beta / CD19+ depleted haploidentical hematopoietic progenitor cell graft
Biological: memory-like natural killer cells
Biological: IL-2
Device: CliniMACS

First Posted Date: 2023-12-06

Last Posted Date: 2024-05-17

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 48

Registration Number: NCT06158828

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

Phase 1

Recruiting

Conditions: Relapsed and/or Refractory Multiple Myeloma

Interventions: Drug: BMS-986453
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2023-12-01

Last Posted Date: 2024-12-20

Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Target Recruit Count: 130

Registration Number: NCT06153251

Locations: 🇪🇸
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
🇫🇷
Hôpital Saint-Louis, Paris, France
🇩🇪
Universitaetsklinikum Heidelberg, Heidelberg, Germany

and more 16 locations

Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma

Phase 2

Recruiting

Conditions: Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Melanoma
Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
Unresectable Melanoma

Interventions: Procedure: Biospecimen Collection
Drug: Cyclophosphamide
Procedure: Echocardiography
Drug: Fludarabine
Biological: Interleukin-2
Biological: Lifileucel
Procedure: Magnetic Resonance Imaging
Procedure: Multigated Acquisition Scan
Procedure: Tumor Resection

First Posted Date: 2023-11-30

Last Posted Date: 2024-02-28

Lead Sponsor: University of Kansas Medical Center

Target Recruit Count: 12

Registration Number: NCT06151847

Locations: 🇺🇸
University of Kansas Cancer Center, Kansas City, Kansas, United States

CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

Phase 1

Recruiting

Conditions: Idiopathic Inflammatory Myopathies
ANCA Associated Vasculitis
Diffuse Cutaneous Systemic Sclerosis
SLE Nephritis

Interventions: Drug: KYV-101
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2023-11-30

Last Posted Date: 2024-10-16

Lead Sponsor: David Porter

Target Recruit Count: 24

Registration Number: NCT06152172

Locations: 🇺🇸
Hospital of the Universithy of Pennsylvania, Philadelphia, Pennsylvania, United States

Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer

Phase 1

Recruiting

Conditions: Breast Neoplasms

Interventions: Procedure: Surgery for harvesting tumor-draining lymph nodes
Drug: Cyclophosphamide
Drug: Fludarabine
Biological: Tumor-draining lymph node-derived lymphocyte (LNL)
Biological: Interleukin-2
Biological: Camrelizumab
Drug: Chemotherapeutic drug, ADC or PARP inhibitor

First Posted Date: 2023-11-08

Last Posted Date: 2023-11-08

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 24

Registration Number: NCT06121557

Locations: 🇨🇳
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Phase I Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes as Neoadjuvant Therapy for HER2-Negative Breast Cancer

Phase 1

Recruiting

Conditions: Breast Neoplasms

Interventions: Procedure: Sentinel Lymph Node Biopsy (SLNB)
Drug: Doxorubicin
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Fludarabine
Biological: Tumor-draining lymph node-derived lymphocyte (LNL)
Biological: Interleukin-2
Drug: Nab-paclitaxel

First Posted Date: 2023-11-08

Last Posted Date: 2023-11-08

Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Target Recruit Count: 24

Registration Number: NCT06121570

Locations: 🇨🇳
Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

Phase 1

Recruiting

Conditions: Relapsed Multiple Myeloma
Multiple Myeloma
Blood Cancer
Relapsed Non-Hodgkin Lymphoma
Refractory Multiple Myeloma
NHL
Refractory Non-Hodgkin Lymphoma

Interventions: Drug: IDP-023
Drug: Cyclophosphamide
Drug: Daratumumab
Drug: Interleukin-2
Drug: Rituximab
Drug: Fludarabine
Drug: Mesna

First Posted Date: 2023-11-07

Last Posted Date: 2025-01-08

Lead Sponsor: Indapta Therapeutics, INC.

Target Recruit Count: 128

Registration Number: NCT06119685

Locations: 🇺🇸
Valkyrie Clinical Trials, Los Angeles, California, United States
🇺🇸
Stanford University, Stanford, California, United States
🇺🇸
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center, Lake Mary, Florida, United States

and more 10 locations

Autologous T Cells Lentivirally Transduced to Express L1CAM-Specific Chimeric Antigen Receptors in Treating Patients With Locally Advanced and Unresectable or Metastatic Small Cell Neuroendocrine Prostate Cancer

Phase 1

Not yet recruiting

Conditions: Prostate Carcinoma
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Prostate Small Cell Neuroendocrine Carcinoma

Interventions: Drug: Bendamustine
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Bridge Therapy
Procedure: Computed Tomography
Drug: Cyclophosphamide
Procedure: Echocardiography
Drug: Fludarabine
Procedure: Leukapheresis
Procedure: Multigated Acquisition Scan
Biological: T-cell Receptor-engineered T-cells
Procedure: X-Ray Imaging

First Posted Date: 2023-10-23

Last Posted Date: 2024-10-17

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 20

Registration Number: NCT06094842

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

UTAA09 Injection in the Treatment of Relapsed/Refractory Hematolymphatic Malignancies.

Early Phase 1

Not yet recruiting

Conditions: CD19-positive Relapsed or Refractory B-cell Malignancies

Interventions: Biological: UTAA09 cells for infusion
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2023-10-23

Last Posted Date: 2023-10-23

Lead Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Target Recruit Count: 10

Registration Number: NCT06092047

Locations: 🇨🇳
The First Affiliated Hospital of USTC (AnHui Provincial Hospital), Hefei, Anhui, China

Relmacabtagene Autoleucel as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL

Phase 2

Not yet recruiting

Conditions: Follicular Lymphoma Grade 3B
Mediastinal B-Cell Diffuse Large Cell Lymphoma
Lymphoma, Large B-Cell, Diffuse
High-grade B-cell Lymphoma

Interventions: Biological: Relmacabtagene Autoleucel
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2023-10-23

Last Posted Date: 2023-10-25

Lead Sponsor: Shanghai Ming Ju Biotechnology Co., Ltd.

Target Recruit Count: 46

Registration Number: NCT06093841

Locations: 🇨🇳
Sun Yat-sen University Cancer Hospital, Guangzhou, Guangdong, China
🇨🇳
Henan Cancer Hospital, Zhengzhou, Henan, China
🇨🇳
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

and more 10 locations

Drug Development Updates

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