Cladribine

Generic Name: Cladribine

Brand Names: Litak, Mavenclad

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₂ClN_₅O_₃

CAS Number: 4291-63-8

Unique Ingredient Identifier: 47M74X9YT5

Background: An antineoplastic agent used in the treatment of lymphoproliferative diseases including hairy-cell leukemia.

Indication: For the treatment of active hairy cell leukemia (leukemic reticuloendotheliosis) as defined by clinically significant anemia, neutropenia, thrombocytopenia, or disease-related symptoms. Also used as an alternative agent for the treatment of chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin's lymphoma, and cutaneous T-cell lymphoma.

Associated Conditions: Chronic Lymphocytic Leukemia, Cutaneous T-Cell Lymphoma (CTCL), Hairy Cell Leukemia (HCL), Non-Hodgkin's Lymphomas, Active confirmed by clinical features, confirmed by imaging features relapsing multiple sclerosis (MS)

Associated Therapies: -

Clinical Trials

Relationship Between Oral DMT Burden and Adherence in MS

Conditions: Multiple Sclerosis
Adherence, Medication

Interventions: Drug: Cladribine
Drug: Fingolimod
Drug: Ozanimod
Drug: Dimethyl fumarate
Drug: Teriflunomide
Drug: Diroximel fumarate

First Posted Date: 2020-12-19

Last Posted Date: 2022-08-31

Lead Sponsor: Monash University

Target Recruit Count: 323

Registration Number: NCT04676204

Locations: 🇦🇺
Monash University, Melbourne, Victoria, Australia

CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia

Phase 1

Recruiting

Conditions: Recurrent Chronic Myelomonocytic Leukemia
Recurrent Myelodysplastic Syndrome
Refractory Acute Myeloid Leukemia
Refractory Chronic Myelomonocytic Leukemia
Refractory Mixed Phenotype Acute Leukemia
Recurrent Acute Myeloid Leukemia
Refractory Myelodysplastic Syndrome
Refractory Acute Leukemia of Ambiguous Lineage
Refractory Acute Undifferentiated Leukemia

Interventions: Drug: Cyclophosphamide
Drug: Cladribine
Drug: Cyclosporine
Drug: Cytarabine
Drug: Mycophenolate Sodium
Biological: Filgrastim
Procedure: Hematopoietic Cell Transplantation
Drug: Mitoxantrone
Drug: Idarubicin
Drug: Mycophenolate Mofetil
Drug: Fludarabine
Radiation: Total-Body Irradiation
Procedure: Multigated Acquisition Scan
Procedure: Echocardiography
Procedure: X-Ray Imaging
Procedure: Bone Marrow Biopsy
Procedure: Bone Marrow Aspiration
Procedure: Biospecimen Collection

First Posted Date: 2020-05-05

Last Posted Date: 2024-11-04

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 120

Registration Number: NCT04375631

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

CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients

Phase 2

Recruiting

Conditions: Myeloid Neoplasm
Acute Myeloid Leukemia

Interventions: Drug: Liposome-encapsulated Daunorubicin-Cytarabine
Drug: Cladribine
Other: Questionnaire Administration
Drug: Cytarabine
Biological: Recombinant Granulocyte Colony-Stimulating Factor
Drug: Mitoxantrone
Other: Quality-of-Life Assessment

First Posted Date: 2019-12-12

Last Posted Date: 2024-03-20

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 60

Registration Number: NCT04195945

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

Continuous Infusion Chemotherapy (CI-CLAM) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms

Phase 1

Terminated

Conditions: Refractory Acute Myeloid Leukemia
Myeloid Neoplasm
Recurrent Acute Myeloid Leukemia

Interventions: Drug: Cladribine
Drug: Cytarabine
Biological: Recombinant Granulocyte Colony-Stimulating Factor
Drug: Mitoxantrone

First Posted Date: 2019-12-12

Last Posted Date: 2023-12-28

Lead Sponsor: University of Washington

Target Recruit Count: 13

Registration Number: NCT04196010

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

Cladribine Tablets After Treatment With Natalizumab (CLADRINA)

Phase 4

Active, not recruiting

Conditions: Multiple Sclerosis

Interventions: Drug: Cladribine

First Posted Date: 2019-11-26

Last Posted Date: 2024-12-02

Lead Sponsor: University of Texas Southwestern Medical Center

Target Recruit Count: 40

Registration Number: NCT04178005

Locations: 🇺🇸
UT Southwestern Medical center, Dallas, Texas, United States
🇺🇸
College Park Family Care Center Physicians Group, Overland Park, Kansas, United States

Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)

Phase 3

Completed

Conditions: Multiple Sclerosis
Relapsing Multiple Sclerosis

Interventions: Biological: Rituximab
Drug: Cladribine

First Posted Date: 2019-10-09

Last Posted Date: 2024-12-16

Lead Sponsor: Oslo University Hospital

Target Recruit Count: 267

Registration Number: NCT04121403

Locations: 🇳🇴
Department of Neurology - Drammen, Vestre Viken HF, Drammen, Buskerud, Norway
🇳🇴
Department of Neurology - Lillehammer, SI Lillehammer, Lillehammer, Oppland, Norway
🇳🇴
Department of Neurology, Stavanger universitetssykehus, Stavanger, Rogaland, Norway

and more 8 locations

Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome

Phase 1

Recruiting

Conditions: Recurrent Acute Biphenotypic Leukemia
Acute Myeloid Leukemia
Recurrent Acute Myeloid Leukemia
Blasts 20 Percent or More of Bone Marrow Nucleated Cells
Refractory Acute Myeloid Leukemia
Refractory High Risk Myelodysplastic Syndrome
High Risk Myelodysplastic Syndrome
Recurrent High Risk Myelodysplastic Syndrome

Interventions: Drug: Cladribine
Drug: Cytarabine
Drug: Idarubicin
Drug: Quizartinib

First Posted Date: 2019-08-07

Last Posted Date: 2024-12-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 80

Registration Number: NCT04047641

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

Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis

Phase 4

Active, not recruiting

Conditions: Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis

Interventions: Drug: Cladribine

First Posted Date: 2019-05-24

Last Posted Date: 2024-03-22

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 47

Registration Number: NCT03963375

Locations: 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States
🇺🇸
Medical College of Wisconsin, Milwaukee, Wisconsin, United States

and more 2 locations

Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

Phase 3

Recruiting

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: DFP-10917
Drug: Cytarabine
Drug: Azacitidine
Drug: Decitabine
Drug: Mitoxantrone
Drug: Etoposide
Drug: Fludarabine
Drug: Idarubicin
Drug: Venetoclax
Drug: Cladribine

First Posted Date: 2019-04-24

Last Posted Date: 2022-10-20

Lead Sponsor: Delta-Fly Pharma, Inc.

Target Recruit Count: 450

Registration Number: NCT03926624

Locations: 🇺🇸
University of California, Irvine, California, United States
🇺🇸
Decatur Memorial Hospital-Cancer Care Specialists of Central IL, Decatur, Illinois, United States
🇺🇸
The University of Mississippi Medical Center, Jackson, Mississippi, United States

and more 36 locations

Effects of Cladribine Tablets on the PK of Microgynon®

Phase 1

Completed

Conditions: Relapsing Multiple Sclerosis (RMS)

Interventions: Drug: Microgynon®
Drug: Cladribine
Drug: Placebo

First Posted Date: 2018-11-19

Last Posted Date: 2024-03-15

Lead Sponsor: Merck KGaA, Darmstadt, Germany

Target Recruit Count: 28

Registration Number: NCT03745144

Locations: 🇵🇱
BioVirtus Research Site Sp, Otwock, Poland
🇩🇪
St. Josef und St. Elisabeth Hospital gGmbH, Bochum, Germany
🇵🇱
M.A. - LEK A.M.Maciejowscy SC., Katowice, Poland

and more 4 locations

Drug Development Updates

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