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

Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

Phase 1

Withdrawn

Conditions: Acute Myeloid Leukemia

Interventions: Drug: CPX-351
Drug: Midostaurin
Drug: Busulfan
Drug: Melphalan
Drug: Fludarabine
Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor

First Posted Date: 2021-07-29

Last Posted Date: 2024-10-01

Lead Sponsor: Guenther Koehne

Target Recruit Count: 20

Registration Number: NCT04982354

Locations: 🇺🇸
Miami Cancer Institute at Baptist Health of South Florida, Miami, Florida, United States

Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)

Phase 2

Recruiting

Conditions: Diamond-Blackfan Anemia
Hereditary Sideroblastic Anemia
Paroxysmal Nocturnal Hemoglobinuria
Shwachman-Diamond Syndrome
Hematologic Neoplasm With Germline GATA2 Mutation
Hematologic Neoplasm With Germline SAMD9 Mutation
Hematologic Neoplasm With Germline SAMD9L Mutation
Bone Marrow Failure Syndrome
Congenital Amegakaryocytic Thrombocytopenia

Interventions: Drug: Treosulfan
Drug: Fludarabine Phosphate
Drug: Tacrolimus
Drug: Methotrexate
Biological: Lapine T-Lymphocyte Immune Globulin
Procedure: Peripheral Blood Stem Cell Transplantation
Procedure: Allogeneic Bone Marrow Transplantation
Other: Quality-of-Life Assessment
Procedure: Echocardiography
Procedure: Multigated Acquisition Scan
Procedure: Bone Marrow Biopsy
Procedure: Bone Marrow Aspiration
Procedure: Biospecimen Collection
Procedure: X-Ray Imaging
Procedure: Computed Tomography

First Posted Date: 2021-07-16

Last Posted Date: 2024-06-17

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 40

Registration Number: NCT04965597

Locations: 🇺🇸
Oregon Health & Science University, Portland, Oregon, United States
🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Cohen Children's Hospital of NY, Queens, New York, United States

and more 21 locations

Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies

Phase 1

Recruiting

Conditions: Hematologic Neoplasms

Interventions: Drug: Mycophenolate Mofetil
Procedure: Allogeneic HSCT
Drug: Fludarabine
Drug: Sirolimus
Drug: Filgrastim
Drug: Cyclophosphamide
Drug: Mesna
Procedure: Total Body Irradiation (TBI)

First Posted Date: 2021-07-13

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 320

Registration Number: NCT04959175

Locations: 🇺🇸
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Benadamustine, Fludarabine and Busulfan Conditioning in Recipients of Haploidentical Stem Cell Transplantation (FluBuBe)

Phase 2

Completed

Conditions: Leukemia, Acute Lymphoblastic
Myeloid Leukemia, Acute
Myelodysplastic Syndromes
Myeloproliferative Neoplasm
Lymphoblastic Lymphoma
Biphenotypic Acute Leukemia

Interventions: Drug: Fludarabine
Drug: Bendamustine Hydrochloride
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Mycophenolate Mofetil
Drug: Tacrolimus 5Mg Cap

First Posted Date: 2021-06-28

Last Posted Date: 2024-05-07

Lead Sponsor: St. Petersburg State Pavlov Medical University

Target Recruit Count: 50

Registration Number: NCT04942730

Locations: 🇷🇺
RM Gorbacheva Research Institute, Saint Petersburg, Russian Federation

A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd) Followed by Cilta-cel, a CAR-T Therapy Directed Against BCMA Versus VRd Followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants With Newly Diagnosed Multiple Myeloma for Whom ASCT is Not Planned as Initial Therapy

Phase 3

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Bortezomib
Drug: Dexamethasone
Drug: Lenalidomide
Drug: Cilta-cel
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2021-06-11

Last Posted Date: 2025-01-10

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 650

Registration Number: NCT04923893

Locations: 🇦🇷
Hospital Privado Universitario De Cordoba, Cordoba, Argentina
🇵🇱
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyOddz w Gliwicach, Gliwice, Poland
🇵🇱
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli, Lublin, Poland

and more 132 locations

ImmPACT Expanded Multiple Antigen Specific Endogenously Derived T Cells (MASE-T) to Patients With Metastatic Melanoma

Phase 1

Terminated

Conditions: Malignant Melanoma

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Biological: Multiple Antigen Specific Endogenously derived T cells
Drug: Pembrolizumab

First Posted Date: 2021-05-27

Last Posted Date: 2024-07-19

Lead Sponsor: Inge Marie Svane

Target Recruit Count: 6

Registration Number: NCT04904185

Locations: 🇩🇰
National Center for Cancer Immune Therapy (CCIT-DK), Herlev, Denmark

HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide

Phase 2

Recruiting

Conditions: Chronic Myelogenous Leukemia
Mixed Phenotype Acute Leukemia
Acute Leukemia
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Acute Myelogenous Leukemia
Myelodysplastic Syndromes
Lymphoma

Interventions: Drug: Busulfan
Radiation: Total-body irradiation
Drug: Melphalan
Drug: Cyclophosphamide
Drug: Fludarabine
Procedure: PBSC Hematopoietic Stem Cell Transplantation (HSCT)
Procedure: Bone Marrow Hematopoietic Stem Cell Transplantation
Drug: Post-transplant Cyclophosphamide
Drug: Mesna
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
Other: Patient-Reported Outcomes

First Posted Date: 2021-05-27

Last Posted Date: 2024-05-23

Lead Sponsor: Center for International Blood and Marrow Transplant Research

Target Recruit Count: 300

Registration Number: NCT04904588

Locations: 🇺🇸
Levine Cancer Institute, Charlotte, North Carolina, United States
🇺🇸
Ohio State Medical Center, James Cancer Center, Columbus, Ohio, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States

and more 37 locations

Study of Selinexor and Venetoclax in Combination With Chemotherapy in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Phase 1

Recruiting

Conditions: Refractory Acute Leukemia of Ambiguous Lineage
Refractory Acute Myeloid Leukemia
Acute Leukemia of Ambiguous Lineage in Relapse
Acute Myeloid Leukemia, in Relapse

Interventions: Drug: Venetoclax
Drug: Selinexor
Drug: Cytarabine
Drug: Fludarabine
Biological: Filgrastim
Drug: Methotrexate
Drug: methotrexate/hydrocortisone/cytarabine

First Posted Date: 2021-05-24

Last Posted Date: 2024-12-18

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 42

Registration Number: NCT04898894

Locations: 🇺🇸
Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States
🇺🇸
Rady Children's Hospital-San Diego, San Diego, California, United States

and more 8 locations

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

Phase 1

Recruiting

Conditions: Osteosarcoma
Neuroblastoma
Desmoplastic Small Round Cell Tumor
Malignant Peripheral Nerve Sheath Tumors
Soft Tissue Sarcoma
Melanoma
Ewing Sarcoma
Adrenocortical Cancer
Rhabdoid Tumor
Pediatric Solid Tumor

Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: MESNA
Drug: B7-H3 CAR T cells

First Posted Date: 2021-05-21

Last Posted Date: 2024-08-19

Lead Sponsor: St. Jude Children's Research Hospital

Target Recruit Count: 32

Registration Number: NCT04897321

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

Cytokine-induced Memory-like NK Cells in Relapsed/Refractory AML and MDS

Phase 2

Withdrawn

Conditions: Relapsed Acute Myeloid Leukemia
Myelodysplastic Syndromes
Refractory Acute Myeloid Leukemia

Interventions: Biological: Cytokine-induced memory-like NK cells
Procedure: Donor Leukapheresis
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Interleukin-2

First Posted Date: 2021-05-20

Last Posted Date: 2022-03-11

Lead Sponsor: Washington University School of Medicine

Registration Number: NCT04893915

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