MedPath

Cladribine

Generic Name
Cladribine
Brand Names
Litak, Mavenclad
Drug Type
Small Molecule
Chemical Formula
C10H12ClN5O3
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
-

A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People with Hairy Cell Leukemia (HCL)

Phase 2
Recruiting
Conditions
Hairy Cell Leukemia
Interventions
First Posted Date
2024-08-20
Last Posted Date
2024-10-02
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
86
Registration Number
NCT06561360
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Mayo Clinic Cancer Center, Rochester, Minnesota, United States

🇺🇸

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

and more 7 locations

Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML

Phase 2
Not yet recruiting
Conditions
Acute Myeloid Leukemia
Acute Monocytic Leukemia
Interventions
Drug: Azacitidine
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Cladribine
Drug: Cytarabine
Procedure: Echocardiography
Procedure: Lumbar Puncture
Procedure: Multigated Acquisition Scan
Other: Questionnaire Administration
Drug: Venetoclax
First Posted Date
2024-07-16
Last Posted Date
2024-07-16
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
40
Registration Number
NCT06504459
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias

Phase 1
Not yet recruiting
Conditions
Refractory Acute Leukemia
Relapsed Acute Leukemia
Interventions
First Posted Date
2024-06-26
Last Posted Date
2024-11-28
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
22
Registration Number
NCT06474663
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Cladribine Venetoclax in Monocytic AML

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia
Interventions
First Posted Date
2024-01-31
Last Posted Date
2025-01-03
Lead Sponsor
University of Colorado, Denver
Target Recruit Count
40
Registration Number
NCT06232655
Locations
🇺🇸

Universtiy of Colorado Hospital, Aurora, Colorado, United States

A Phase 1, Open-Label, Sequential Cross-over, Bioavailability/Bioequivalence Study to Compare the Pharmacokinetics of Oral Cladribine With the Reference Listed Drug, Intravenous Cladribine

Phase 1
Recruiting
Conditions
Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Interventions
First Posted Date
2023-09-01
Last Posted Date
2024-12-24
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
40
Registration Number
NCT06021600
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

First Posted Date
2023-08-23
Last Posted Date
2024-08-13
Lead Sponsor
Medical College of Wisconsin
Registration Number
NCT06007911
Locations
🇺🇸

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction

Phase 2
Not yet recruiting
Conditions
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Interventions
First Posted Date
2023-03-13
Last Posted Date
2024-12-13
Lead Sponsor
University of Florida
Target Recruit Count
98
Registration Number
NCT05766514
Locations
🇺🇸

University of Florida, Gainesville, Florida, United States

Cladribine Combined With G-CSF and Cytarabine as a Salvage Treatment in R/R ALL

Phase 2
Recruiting
Conditions
Acute Lymphoblastic Leukemia
Interventions
First Posted Date
2022-10-13
Last Posted Date
2022-10-13
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
32
Registration Number
NCT05578378
Locations
🇨🇳

The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

ChiCGB vs BEAM in High-risk or R/R Lymphomas

Phase 3
Recruiting
Conditions
Lymphoma, Large B-Cell, Diffuse
Lymphoma, T-Cell
Interventions
First Posted Date
2022-07-20
Last Posted Date
2022-07-25
Lead Sponsor
Sichuan University
Target Recruit Count
306
Registration Number
NCT05466318
Locations
🇨🇳

Chengdu Third People's Hospital, Chendu, Sichuan, China

🇨🇳

People's Hospital of Deyang City, Deyang, Deyang, China

🇨🇳

West China Hospital, Sichuan University, Chendu, Sichuan, China

and more 8 locations

A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Azacitidine and Venetoclax, in Patients With Higher-risk Myeloproliferative Chronic Myelomonocytic Leukemia or Higher-risk Myelodysplastic Syndromes With Excess Blasts

Phase 2
Recruiting
Conditions
Myelodysplastic Syndromes
Myeloproliferative Chronic Myelomonocytic Leukemia
Interventions
First Posted Date
2022-05-06
Last Posted Date
2024-06-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
60
Registration Number
NCT05365035
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

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