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

A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma

Phase 2

Recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Axicabtagene Ciloleucel
Drug: Cyclophosphamide
Drug: Fludarabine phosphate
Drug: Prednisone
Drug: Diphenhydramine
Drug: Acetaminophen

First Posted Date: 2023-09-21

Last Posted Date: 2025-01-01

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT06043323

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

Combination Chemotherapy (FLAG-Ida) With Pivekimab Sunirine (PVEK [IMGN632]) for the Treatment of Newly Diagnosed Adverse Risk Acute Myeloid Leukemia and Other High-Grade Myeloid Neoplasms

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia
Myeloproliferative Neoplasm
Mixed Phenotype Acute Leukemia
Myelodysplastic Syndrome
Myelodysplastic/Myeloproliferative Neoplasm

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Cytarabine
Procedure: Echocardiography
Drug: Fludarabine
Drug: Granulocyte Colony-Stimulating Factor
Drug: Idarubicin
Procedure: Multigated Acquisition Scan
Drug: Pivekimab Sunirine

First Posted Date: 2023-09-13

Last Posted Date: 2024-07-18

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 30

Registration Number: NCT06034470

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

Risk-ADAPTed Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation

Phase 2

Recruiting

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic Stem Cell Transplantation
Hematologic Malignancies

Interventions: Drug: Fludarabine
Drug: Melphalan
Radiation: Total Body Irradiation

First Posted Date: 2023-09-08

Last Posted Date: 2024-03-15

Lead Sponsor: University of California, Irvine

Target Recruit Count: 60

Registration Number: NCT06028828

Locations: 🇺🇸
Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, California, United States

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Phase 1

Recruiting

Conditions: Refractory Non-Hodgkin Lymphoma
Non-hodgkin Lymphoma
Relapsed Non-Hodgkin Lymphoma
Follicular Lymphoma
Diffuse Large B Cell Lymphoma
Marginal Zone Lymphoma
Primary Mediastinal Large B-cell Lymphoma (PMBCL)
High-grade B-cell Lymphoma
Grade 3b Follicular Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: CD79b-19 CAR T cells
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2023-09-07

Last Posted Date: 2024-04-29

Lead Sponsor: Marcela V. Maus, M.D.,Ph.D.

Target Recruit Count: 24

Registration Number: NCT06026319

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases

Phase 2

Recruiting

Conditions: Acute Leukemia of Ambiguous Lineage
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Hematopoietic and Lymphoid System Neoplasm
Mixed Phenotype Acute Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Non-Hodgkin Lymphoma
Chronic Myeloid Leukemia, BCR-ABL1 Positive

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspirate
Drug: Cyclophosphamide
Drug: Cyclosporine
Procedure: Diagnostic Imaging
Procedure: Echocardiography
Drug: Fludarabine Phosphate
Procedure: Multigated Acquisition Scan
Drug: Mycophenolate Mofetil
Other: Survey Administration
Drug: Thiotepa
Radiation: Total-Body Irradiation
Procedure: Umbilical Cord Blood Transplantation

First Posted Date: 2023-08-28

Last Posted Date: 2024-08-23

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 54

Registration Number: NCT06013423

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

TRAC and Power3 Genes Knock-out Allogeneic CD19-targeting CAR-T Cell Therapy in r/r B-NHL

Phase 1

Recruiting

Conditions: Non Hodgkin's Lymphoma

Interventions: Biological: TRAC and Power3 Genes Knock-out Allogeneic CD19-targeting CAR-T cell (ATHENA CAR-T)
Drug: Fludarabine
Drug: Cyclophosphamide

First Posted Date: 2023-08-28

Last Posted Date: 2023-09-11

Lead Sponsor: Chinese PLA General Hospital

Target Recruit Count: 30

Registration Number: NCT06014073

Locations: 🇨🇳
EdiGene Inc, Beijing, China
🇨🇳
Biotherapeutic Department, Chinese PLA General Hospital, Beijing, China
🇨🇳
School of Life Sciences, Peking University, Beijing, China

A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)

Phase 1

Not yet recruiting

Conditions: B-cell Acute Lymphoblastic Leukemia

Interventions: Biological: HY004
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate

First Posted Date: 2023-08-24

Last Posted Date: 2024-03-08

Lead Sponsor: Juventas Cell Therapy Ltd.

Target Recruit Count: 50

Registration Number: NCT06009107

CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)

Phase 1

Recruiting

Conditions: B-cell Lymphoma

Interventions: Biological: CAR20(NAP)-T
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2023-08-21

Last Posted Date: 2024-05-09

Lead Sponsor: Uppsala University

Target Recruit Count: 18

Registration Number: NCT06002659

Locations: 🇸🇪
Karolinska University Hospital, Stockholm, Sweden
🇸🇪
Uppsala University Hospital, Uppsala, Sweden

HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation with Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis

Phase 2

Recruiting

Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Chronic Myeloid Leukemia
Chronic Lymphocytic Leukemia
Chronic Myelomonocytic Leukemia
Acute Leukemia
Pro-Lymphocytic Leukemia
Acute Lymphoblastic Leukemia
Myelofibrosis
Myeloproliferative Neoplasm

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

First Posted Date: 2023-08-21

Last Posted Date: 2024-11-27

Lead Sponsor: Center for International Blood and Marrow Transplant Research

Target Recruit Count: 190

Registration Number: NCT06001385

Locations: 🇺🇸
Mayo Clinic Arizona, Phoenix, Arizona, United States
🇺🇸
Colorado Blood Cancer Institute at Presbyterian St. Luke's, Denver, Colorado, United States
🇺🇸
City of Hope, Duarte, California, United States

and more 21 locations

Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Phase 1

Recruiting

Conditions: AML
AML With Mutated NPM1
KMT2Ar
Hematologic Malignancy
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
NPM1 Mutation
Leukemia, Myeloid
MLL Rearrangement
Leukemia

Interventions: Drug: Ziftomenib
Drug: Fludarabine
Drug: Idarubicin
Drug: Cytarabine
Drug: Gilteritinib
Biological: Granulocyte colony-stimulating factor

First Posted Date: 2023-08-21

Last Posted Date: 2024-08-29

Lead Sponsor: Kura Oncology, Inc.

Target Recruit Count: 171

Registration Number: NCT06001788

Locations: 🇺🇸
The University of Kansas, Kansas City, Kansas, United States
🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States
🇺🇸
Prisma Health, Greenville, South Carolina, United States

and more 11 locations

Drug Development Updates

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