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 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)

Phase 1

Not yet recruiting

Conditions: Phase 1
Recurrent Melanoma
Refractory Melanoma

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2024-10-28

Last Posted Date: 2024-12-09

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 39

Registration Number: NCT06660420

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

TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas

Phase 1

Recruiting

Conditions: Brain Tumor
Brain Metastases
Brain Cancer
Glioma
Gliomas, Malignant
Glioblastoma
Meningioma

Interventions: Biological: Tumor Infiltrating Lymphocytes (TIL)
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Interleukin-2
Drug: Pembrolizumab

First Posted Date: 2024-10-15

Last Posted Date: 2024-11-05

Lead Sponsor: Essen Biotech

Target Recruit Count: 85

Registration Number: NCT06640582

Locations: 🇨🇳
District One Hospital, Beijing, Beijing, China

STIL101 for Injection for the Treatment of Locally Advanced, Metastatic or Unresectable Pancreatic Cancer, Colorectal Cancer, Renal Cell Cancer, Cervical Cancer and Melanoma

Phase 1

Not yet recruiting

Conditions: Locally Advanced Cervical Carcinoma
Locally Advanced Colorectal Carcinoma
Locally Advanced Malignant Solid Neoplasm
Locally Advanced Melanoma
Locally Advanced Pancreatic Ductal Adenocarcinoma
Locally Advanced Renal Cell Carcinoma
Metastatic Cervical Carcinoma
Metastatic Colorectal Carcinoma
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma

Interventions: Biological: Aldesleukin
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Cyclophosphamide
Procedure: Excisional Biopsy
Drug: Fludarabine
Procedure: Magnetic Resonance Imaging
Procedure: Standard Treatment
Biological: Therapeutic Tumor Infiltrating Lymphocytes

First Posted Date: 2024-10-03

Last Posted Date: 2024-10-03

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 12

Registration Number: NCT06626256

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)

Phase 3

Not yet recruiting

Conditions: Relapsed or Refractory Multiple Myeloma (RRMM)

Interventions: Drug: BMS-986393
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Carfilzomib
Drug: Daratumumab
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2024-09-26

Last Posted Date: 2024-12-20

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

Target Recruit Count: 440

Registration Number: NCT06615479

Locations: 🇦🇺
Local Institution - 0190, Liverpool, New South Wales, Australia
🇦🇺
Local Institution - 0191, Melbourne, Victoria, Australia
🇺🇸
Local Institution - 0071, Birmingham, Alabama, United States

and more 108 locations

Twice-per-weekSelinexor, 2 Days Melphalan

Phase 3

Not yet recruiting

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Selinexor
Drug: Melphalan
Drug: Intravenous Busulfan
Drug: Fludarabine

First Posted Date: 2024-09-25

Last Posted Date: 2024-09-25

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 126

Registration Number: NCT06613035

Locations: 🇨🇳
Zhengzhou University First Affiliated Hospital, Zhengzhou, Henan, China
🇨🇳
Hebei Medical University Second Hospital, Shijiazhuang, hebeisheng, China
🇨🇳
The 960th Hospital of the Joint Service Support Force of the Chinese People's Liberation Army, Jinan, Shandong, China

and more 1 locations

FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1

Not yet recruiting

Conditions: Recurrent Childhood Acute Myeloid Leukemia
Refractory Childhood Acute Myeloid Leukemia

Interventions: Biological: FOLR1 CAR T-cells
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Cyclophosphamide
Procedure: Echocardiography
Drug: Fludarabine
Procedure: Pheresis
Procedure: Positron Emission Tomography

First Posted Date: 2024-09-24

Last Posted Date: 2024-10-08

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 12

Registration Number: NCT06609928

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

A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors

Phase 1

Recruiting

Conditions: Select Advanced Solid Tumors

Interventions: Drug: Cyclophosphamide
Drug: Fludarabine
Drug: KSQ-004EX
Drug: Interleukin-2

First Posted Date: 2024-09-19

Last Posted Date: 2024-12-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 141

Registration Number: NCT06598371

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

Open-label Single-Center Study to Evaluate the Safety and Efficacy of Combining Rituximab and AB-101 in B-cell Associated Autoimmune Diseases.

Phase 1

Recruiting

Conditions: Rheumatoid Arthritis
Pemphigus Vulgaris
Granulomatosis With Polyangiitis
Systemic Lupus Erythematosus

Interventions: Drug: AB-101
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2024-09-03

Last Posted Date: 2024-09-03

Lead Sponsor: IRIS Research and Development, LLC

Target Recruit Count: 30

Registration Number: NCT06581562

Locations: 🇺🇸
IRIS Research and Development, LLC, Plantation, Florida, United States

A Study of Different Sequences of Cilta-cel, Talquetamab in Combination With Daratumumab and Teclistamab in Combination With Daratumumab Following Induction With Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in Participants With Standard-risk Newly Diagnosed Multiple Myeloma

Phase 2

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Cilta-cel
Drug: Talquetamab
Drug: Daratumumab
Drug: Bortezomib
Drug: Teclistamab
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Cyclophosphamide
Drug: Fludarabine

First Posted Date: 2024-08-29

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 40

Registration Number: NCT06577025

Locations: 🇪🇸
Hosp Clinico Univ de Salamanca, Salamanca, Spain
🇪🇸
Hosp. Univ. Marques de Valdecilla, Santander, Spain
🇺🇸
City of Hope, Duarte, California, United States

and more 5 locations

Multi-antigen Specific CD8+ T Cells With Decitabine and Lymphodepleting Chemotherapy for the Treatment of Patients With Relapsed or Refractory AML or MDS Following an Allogeneic Hematopoietic Cell Transplantation From a Matched Donor

Phase 1

Not yet recruiting

Conditions: Recurrent Acute Myeloid Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Refractory Myelodysplastic Syndrome

Interventions: Biological: Allogeneic CD8+ Leukemia-associated Antigens Specific T Cells NEXI-001
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Cyclophosphamide
Drug: Decitabine
Procedure: Echocardiography
Drug: Fludarabine
Procedure: Leukapheresis
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography

First Posted Date: 2024-08-27

Last Posted Date: 2025-01-03

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 31

Registration Number: NCT06572631

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Drug Development Updates

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