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)

Clinical Trials

Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS

Phase 2

Recruiting

Conditions: Myelodysplastic Syndrome
Chronic Myelomonocytic Leukemia
Acute Myeloid Leukemia

Interventions: Drug: Busulfan
Drug: Cladribine
Drug: Fludarabine Phosphate
Procedure: Hematopoietic Cell Transplantation
Drug: Thiotepa
Drug: Venetoclax

First Posted Date: 2021-01-13

Last Posted Date: 2025-04-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 324

Registration Number: NCT04708054

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

ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis

Phase 2

Recruiting

Conditions: Progressive Multiple Sclerosis
Advanced Multiple Sclerosis

Interventions: Drug: Cladribine (MAVENCLAD®)
Drug: Placebo

First Posted Date: 2021-01-05

Last Posted Date: 2025-03-10

Lead Sponsor: Queen Mary University of London

Target Recruit Count: 200

Registration Number: NCT04695080

Locations: 🇬🇧
Morriston Hospital, Swansea, Swansea, United Kingdom
🇬🇧
Luton and Dunstable Hospital, Luton, United Kingdom
🇬🇧
Salford Royal Hospital NHS Trust, Manchester, United Kingdom

and more 19 locations

the Efficacy and Safety of CLAE in R/R T-ALL/LBL

Conditions: Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

First Posted Date: 2020-12-22

Last Posted Date: 2020-12-22

Lead Sponsor: Peking University Third Hospital

Target Recruit Count: 50

Registration Number: NCT04679506

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

Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy

Conditions: Multiple Sclerosis

Interventions: Drug: Cladribine Oral Tablet
Drug: Rituximab
Drug: Ocrelizumab

First Posted Date: 2020-11-23

Last Posted Date: 2022-03-23

Lead Sponsor: Claudio Gobbi

Target Recruit Count: 45

Registration Number: NCT04640818

Locations: 🇨🇭
Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, Ticino, Switzerland

A Prospective Biomarker Study in Active SPMS Subjects Treated With Cladribine Tablets

Phase 4

Recruiting

Conditions: Multiple Sclerosis

Interventions: Drug: Cladribine Tablets

First Posted Date: 2020-09-16

Last Posted Date: 2022-01-13

Lead Sponsor: Keith Edwards, M.D.

Target Recruit Count: 30

Registration Number: NCT04550455

Locations: 🇺🇸
Multiple Sclerosis Center of Northeastern New York, P.C., Latham, New York, United States

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: 2025-02-20

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

Efficacy and Safety of Cladribine in Combination With CAG in Newly Diagnosed Unfit Patients With AML

Phase 2

Conditions: Acute Myeloid Leukemia
Newly Diagnosed
Elderly Patients

Interventions: Drug: Cladribine Injection
Drug: Aclarubicin
Drug: G-CSF
Drug: cytarabine

First Posted Date: 2020-02-05

Last Posted Date: 2020-12-17

Lead Sponsor: Sun Yat-sen University

Target Recruit Count: 34

Registration Number: NCT04254640

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

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

Active, not 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: 2025-03-24

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

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