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

Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances

Phase 1

Recruiting

Conditions: Hematological Malignancy

Interventions: Drug: Fludarabine Phosphate
Drug: Cyclophosphamide
Drug: CAR.5/IL15-transduced CB-NK cells

First Posted Date: 2021-11-08

Last Posted Date: 2025-01-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 48

Registration Number: NCT05110742

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

Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances

Phase 1

Recruiting

Conditions: Acute Myeloid Leukemia (AML)
B-Cell Lymphoma
Myelodysplastic Syndromes (MDS)

Interventions: Drug: CAR.70/IL15-transduced CB-NK cells
Drug: Cyclophosphamide
Drug: Fludarabine phosphate

First Posted Date: 2021-10-25

Last Posted Date: 2024-11-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 94

Registration Number: NCT05092451

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

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

Phase 1

Recruiting

Conditions: Allogeneic Hematopoietic Cell Transplantation (HCT)
Advanced Hematologic Malignancies
Acute Leukemia
Chronic Myelogenous Leukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders

Interventions: Drug: Purified regulatory T-cells (Treg) plus CD34+ HSPC
Drug: Fludarabine
Drug: Tacrolimus
Drug: Melphalan
Device: CliniMACS CD34 Reagent System
Drug: Plerixafor
Drug: Filgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent
Drug: Thiotepa
Drug: Cyclophosphamide
Drug: Mycophenolate Mofetil (MMF)
Drug: Ruxolitinib

First Posted Date: 2021-10-21

Last Posted Date: 2024-02-20

Lead Sponsor: Stanford University

Target Recruit Count: 40

Registration Number: NCT05088356

Locations: 🇺🇸
Stanford University, Stanford, California, United States

Immune Cell Therapy (CAR-T) for the Treatment of Patients With HIV and B-Cell Non-Hodgkin Lymphoma

Phase 1

Recruiting

Conditions: Recurrent High Grade B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory High Grade B-Cell Lymphoma
Refractory Transformed B-Cell Non-Hodgkin Lymphoma
HIV Infection
Recurrent Grade 3b Follicular Lymphoma
Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Non-Hodgkin Lymphoma
Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma

Interventions: Biological: Axicabtagene Ciloleucel
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2021-10-14

Last Posted Date: 2024-11-08

Lead Sponsor: AIDS Malignancy Consortium

Target Recruit Count: 20

Registration Number: NCT05077527

Locations: 🇺🇸
University of Illinois at Chicago, Chicago, Illinois, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Phase 1

Terminated

Conditions: Solid Tumor, Adult

Interventions: Drug: FT538
Drug: Cyclophosphamide
Drug: Fludarabine
Combination Product: Monoclonal antibody - Dose Escalation
Combination Product: Monoclonal antibody - Dose Expansion

First Posted Date: 2021-10-06

Last Posted Date: 2023-09-21

Lead Sponsor: Fate Therapeutics

Target Recruit Count: 16

Registration Number: NCT05069935

Locations: 🇺🇸
NEXT Oncology, San Antonio, Texas, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 1 locations

Fludarabine and Cyclophosphamide With or Without Rituximab Before CD19 Chimeric Antigen Receptor T Cells for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 1

Recruiting

Conditions: Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma

Interventions: Biological: Chimeric Antigen Receptor T-Cell Therapy
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Biological: Rituximab

First Posted Date: 2021-09-22

Last Posted Date: 2024-05-13

Lead Sponsor: Mehrdad Abedi, MD

Target Recruit Count: 36

Registration Number: NCT05052528

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

A PHASE IB STUDY OF IMMUNOTHERAPY WITH EX VIVO PRE-ACTIVATED AND EXPANDED CB-NK CELLS IN COMBINATION WITH CETUXIMAB, IN COLORECTAL CANCER PATIENTS WITH MINIMAL RESIDUAL DISEASE (MRD)

Phase 1

Active, not recruiting

Conditions: Colon Cancer
Resected Stage

Interventions: Drug: Cetuximab
Drug: Expanded CB-NK cells
Drug: Fludarabine phosphate
Drug: Cyclophosphamide

First Posted Date: 2021-09-10

Last Posted Date: 2024-12-10

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 15

Registration Number: NCT05040568

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

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Phase 1

Recruiting

Conditions: Kita-kyushu Lung Cancer Antigen 1, Human

Interventions: Drug: IL-2 (Aldesleukin)
Drug: Cyclophosphamide
Biological: KK-LC-1 TCR
Drug: Fludarabine

First Posted Date: 2021-09-05

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 100

Registration Number: NCT05035407

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

Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant

Phase 2

Recruiting

Conditions: Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Adult T-Cell Leukemia/Lymphoma
Aplastic Anemia
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia, BCR-ABL1 Positive
Chronic Myelomonocytic Leukemia
Essential Thrombocythemia
Hematopoietic and Lymphatic System Neoplasm
Hodgkin Lymphoma

Interventions: Drug: Fludarabine
Radiation: Total-Body Irradiation
Procedure: Donor Lymphocyte Infusion
Drug: Cyclophosphamide
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
Procedure: Hematopoietic Cell Transplantation
Procedure: Bone Marrow Aspiration and Biopsy
Drug: Melphalan
Procedure: Diagnostic Imaging
Procedure: Biospecimen Collection

First Posted Date: 2021-09-02

Last Posted Date: 2024-10-14

Lead Sponsor: Thomas Jefferson University

Target Recruit Count: 63

Registration Number: NCT05031897

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Subjects With VEXAS (Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic) Syndrome

Phase 2

Recruiting

Conditions: Immunodeficiency
Hematopoietic Stem Cell Transplantation

Interventions: Procedure: Allogeneic HSCT
Drug: Busulfan test dose
Drug: Mycophenolate mofetil (MMF)
Drug: Tacrolimus
Drug: Busulfan
Radiation: Total Body Irradiation (TBI)
Drug: Fludarabine
Drug: Post-Transplant Cyclophosphamide (PTCY)
Drug: Cyclophosphamide (CY)

First Posted Date: 2021-08-31

Last Posted Date: 2024-11-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 54

Registration Number: NCT05027945

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

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