Clofarabine

Generic Name: Clofarabine

Brand Names: Clolar, Evoltra

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₁₁ClFN_₅O_₃

CAS Number: 123318-82-1

Unique Ingredient Identifier: 762RDY0Y2H

Background: Clofarabine is a purine nucleoside antimetabolite that is being studied in the treatment of cancer. It is marketed as Clolar in the U.S. and Canada, or Evoltra in Europe, Australia, and New Zealand. Clofarabine is used in paediatrics to treat a type of leukaemia called relapsed or refractory acute lymphoblastic leukaemia (ALL), only after at least two other ...

Indication: For the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphocytic (lymphoblastic) leukemia after at least two prior regimens. It is designated as an orphan drug by the FDA for this use.

Associated Conditions: Refractory Acute Lymphoblastic Leukemia (ALL), Refractory Acute Myeloid Leukemia (AML), Relapsed Acute Lymphoblastic Leukemia (ALL), Refractory Langerhans cell histiocytosis

Associated Therapies: -

Clinical Trials

Clofarabine and Low-Dose Total-Body Irradiation in Treating Patients With Acute Myeloid Leukemia Undergoing Donor Peripheral Blood Stem Cell Transplant

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Clofarabine
Drug: Cyclosporine
Other: Laboratory Biomarker Analysis
Drug: Mycophenolate Mofetil
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Pharmacological Study
Radiation: Total-Body Irradiation

First Posted Date: 2010-12-03

Last Posted Date: 2020-04-16

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 44

Registration Number: NCT01252667

Locations: 🇺🇸
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
🇺🇸
VA Puget Sound Health Care System, Seattle, Washington, United States

and more 1 locations

Clofarabine or High-Dose Cytarabine and Pegaspargase in Children with ALL

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Amsacrine
Drug: Cyclophosphamide
Drug: Clofarabine
Drug: Cytarabine
Drug: Dexamethasone
Drug: Daunorubicin hydrochloride
Drug: Doxorubicin hydrochloride
Drug: Etoposide phosphate
Drug: Mercaptopurine
Drug: Methotrexate
Drug: Methylprednisolone
Drug: Pegaspargase
Drug: Thioguanine
Drug: Vincristine sulfate
Radiation: Whole-brain radiation therapy

First Posted Date: 2010-10-26

Last Posted Date: 2024-12-11

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Target Recruit Count: 745

Registration Number: NCT01228331

Locations: 🇩🇪
Universitaetsklinikum Duesseldorf, Duesseldorf, Germany
🇩🇪
University Medical Center Hamburg - Eppendorf, Hamburg, Germany
🇩🇪
Johannes Gutenberg University, Mainz, Germany

and more 11 locations

A Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia

Phase 1

Completed

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Clofarabine

First Posted Date: 2010-09-08

Last Posted Date: 2014-03-19

Lead Sponsor: Genzyme, a Sanofi Company

Target Recruit Count: 7

Registration Number: NCT01196013

Locations: 🇯🇵
St. Luke's International Hospital, Tokyo, Japan
🇯🇵
National Kyusyu Cancer Center, Fukuoka, Japan
🇯🇵
Tokai University Hospital, Kanagawa, Japan

and more 6 locations

Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years

Phase 2

Terminated

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Clofarabine
Drug: Cytarabine

First Posted Date: 2010-09-01

Last Posted Date: 2014-04-07

Lead Sponsor: PETHEMA Foundation

Target Recruit Count: 75

Registration Number: NCT01193400

Locations: 🇪🇸
Hospital de la Santa Creu i Sant Pau., Barcelona, Spain
🇪🇸
Hospital Durán i Reynals (Bellvitge)., Barcelona, Spain
🇪🇸
Hospital General de Alicante., Alicante, Spain

and more 12 locations

Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure

Phase 2

Completed

Conditions: AML

Interventions: Drug: Clofarabine

First Posted Date: 2010-08-25

Last Posted Date: 2014-12-05

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 26

Registration Number: NCT01188174

Locations: 🇫🇷
Nantes University hospital, Nantes, France
🇫🇷
CHU Caen, Caen, France
🇫🇷
CHRU lille, Lille, France

and more 6 locations

PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias

Phase 1

Completed

Conditions: Myelodysplastic Syndrome
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Myelomonocytic Leukemia

Interventions: Drug: Clofarabine

First Posted Date: 2010-07-23

Last Posted Date: 2017-08-22

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 13

Registration Number: NCT01169012

Locations: 🇺🇸
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Plerixafor and Clofarabine in Frontline Treatment of Elderly Patients With Acute Myelogenous Leukemia (AML)

Phase 1

Terminated

Conditions: Acute Myelogenous Leukemia

Interventions: Drug: Plerixafor
Drug: Clofarabine

First Posted Date: 2010-07-12

Last Posted Date: 2019-08-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 22

Registration Number: NCT01160354

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

Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia

Phase 2

Terminated

Conditions: Minimal Residual Disease
Leukemia, Lymphoblastic, Acute
Leukemia, Myelogenous, Acute

Interventions: Drug: Clofarabine
Drug: Cytarabine intravenous
Drug: Methotrexate
Drug: Intrathecal (IT) Cytarabine

First Posted Date: 2010-07-08

Last Posted Date: 2021-10-26

Lead Sponsor: Therapeutic Advances in Childhood Leukemia Consortium

Target Recruit Count: 2

Registration Number: NCT01158885

Locations: 🇺🇸
Seattle Children's Hospital, Seattle, Washington, United States
🇺🇸
Carolina-Levine Children's Hospital, Charlotte, North Carolina, United States

Entinostat and Clofarabine in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Poor-Risk Acute Lymphoblastic Leukemia or Bilineage/Biphenotypic Leukemia

Phase 1

Completed

Conditions: Acute Leukemias of Ambiguous Lineage
Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia
Recurrent Adult Acute Lymphoblastic Leukemia
Untreated Adult Acute Lymphoblastic Leukemia

Interventions: Drug: entinostat
Drug: clofarabine
Other: pharmacological study
Other: laboratory biomarker analysis

First Posted Date: 2010-05-28

Last Posted Date: 2014-07-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 27

Registration Number: NCT01132573

Locations: 🇺🇸
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

and more 1 locations

HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies

Phase 2

Completed

Conditions: Multiple Myeloma
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome

Interventions: Drug: Thiotepa
Radiation: total body irradiation
Drug: Busulfan
Drug: Melphalan
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Clofarabine
Procedure: (CliniMACS) T-cell depleted PBSC Transplant

First Posted Date: 2010-05-07

Last Posted Date: 2022-08-05

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 422

Registration Number: NCT01119066

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

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