Clolar

(clofarabine)

ApprovedSmall molecule

Clofarabine is used to treat acute leukemia (a type of blood cancer) in children and young adults. It works by killing cancer cells that grow too quickly.[2] Clolar is currently approved and in use across 16 indications[4].[1]

Clolar is one of 265 small molecule programs targeting Langerhans Cell Histiocytosis. It is currently in Approved.

Indications

144

Total Trials

Active Trials

264

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Langerhans Cell HistiocytosisWithdrawn

OsteopetrosisApproved

Neoplasm of Mature B-CellsApproved

Non-Hodgkins LymphomaApproved

Bone Marrow TransplantationActive, not recruiting

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveRecruiting

Recurrent Acute Lymphoblastic LeukemiaRecruiting

Adult Acute Lymphoblastic Leukemia in RemissionActive, not recruiting

Hematopoietic Stem Cell TransplantCompleted

PediatricRecruiting

Langerhans Cell HistiocytosisPhase 2

Withdrawn

OsteopetrosisApproved

Approved

Neoplasm of Mature B-CellsApproved

Approved

Non-Hodgkins LymphomaApproved

Approved

Bone Marrow TransplantationPreclinical

Active, not recruiting

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositivePhase 2

Recruiting

Recurrent Acute Lymphoblastic LeukemiaPhase 2

Recruiting

Adult Acute Lymphoblastic Leukemia in RemissionPhase 2

Active, not recruiting

Hematopoietic Stem Cell TransplantPreclinical

Completed

PediatricPhase 1

Recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

163 competitors in Acute Lymphoblastic Leukemia

#DrugCompanyPhaseTrials

Oncovin

Eli Lilly

Phase 3

75 2

Adriamycin

Pfizer

Phase 3

40 3

Clolar

GGenzyme, a Sanofi Company

Approved

13 4

Oncaspar

SServier

Phase 3

48 5

Wellcovorin

EEastern Cooperative Oncology Group

Phase 3

40 6

Cerubidine

EEastern Cooperative Oncology Group

Phase 3

43 7

Fludara

Sanofi

Phase 3

15 8

Iclusig

Takeda

Phase 3

12 9

Cellcept

Neoral

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Acute Lymphoblastic Leukemia

NCT02883049

Phase 2Recruiting

Non-Malignant Disorders

NCT04644016

Phase 2Active, not recruiting

Langerhans Cell Histiocytosis

NCT02425904

Q2 2027

Phase 2Recruiting

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

NCT02727803

Q3 2027

Phase 2Recruiting

Recurrent Acute Lymphoblastic Leukemia

NCT03136146

Q3 2028

Phase 2Recruiting

Transplantation

NCT06252870

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia21 trials

A Study of Clofarabine in Japanese Patients With Acute Myeloid Leukemia (AML)

Completed· Sanofi logo

Sanofi·Phase 1·NCT01090167·14 enrolled

Oral Clofarabine for Acute Myeloid Leukemia

Completed·WWashington University School of Medicine·Phase 1·NCT00727766·25 enrolled

Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia

Unknown status·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 1/2·NCT00838240·114 enrolled

Show 18 more trials

Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00469014·72 enrolled

Study of Clofarabine & Cytosine Arabinoside Therapy for Older Adults With Acute Myeloid Leukemia

Completed·UUniversity of Alabama at Birmingham·Phase 1·NCT00081822·23 enrolled

Clofarabine and Gemtuzumab in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Terminated·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT00577694·21 enrolled

Clofarabine and Temsirolimus in Treating Older Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·GGruppo Italiano Malattie EMatologiche dell'Adulto·Phase 2·NCT00775593·60 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation (AlloSCT) Initial Salvage Therapy for Induction Failure Acute Myeloid Leukemia (AML)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02441803·11 enrolled

Clofarabine and Daunorubicin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Terminated·RRoswell Park Cancer Institute·Phase 2·NCT00814164·21 enrolled

Phase II Clofarabine and Cytarabine for Newly Diagnosed Acute Myeloid Leukemia

Terminated·UUniversity of Pittsburgh·Phase 2·NCT01960387·2 enrolled

Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Completed·EECOG-ACRIN Cancer Research Group·Phase 3·NCT02085408·727 enrolled

The Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia

Withdrawn·NNorthwestern University·Phase 1·NCT01065545

Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease

Terminated·UUniversity of Washington·Phase 2·NCT00863434·2 enrolled

Clofarabine, Cytarabine, and Filgrastim Followed by Infusion of Non-HLA Matched Ex Vivo Expanded Cord Blood Progenitors in Treating Patients With Acute Myeloid Leukemia

Completed·NNohla Therapeutics, Inc.·Phase 1·NCT01031368·29 enrolled

Clofarabine Salvage Therapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

Completed·TTechnische Universität Dresden·Phase 2·NCT01295307·86 enrolled

Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Study Of NK Cell Transplantation In Newly Diagnosed Acute Myeloid Leukemia

Completed·SSt. Jude Children's Research Hospital·Phase 3·NCT00703820·324 enrolled

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

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT01252667·44 enrolled

Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01025154·63 enrolled

A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable

Completed· Sanofi logo

Sanofi·Phase 2·NCT00924443·69 enrolled

Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Completed·UUniversity of Washington·Phase 1/2·NCT00602225·50 enrolled

A Phase II Randomized Study to Assess Outcomes With Treosulfan-Based Versus Clofarabine-Based Conditioning in Patients With Myelodysplastic Syndromes With Excess Blasts (MDS-EB), or Acute Myeloid Leukemia (AML) Undergoing Allogeneic Hematopoietic Cell Transplantation (HCT)

Terminated·FFred Hutchinson Cancer Center·Phase 2·NCT04994808·23 enrolled

Acute Lymphoblastic Leukemia13 trials

Cytarabine and Clofarabine in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Completed·WWake Forest University Health Sciences·Phase 1·NCT00295841·53 enrolled

Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Completed·CChildren's Oncology Group·Phase 1/2·NCT00372619·74 enrolled

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Active, not recruiting·SSt. Jude Children's Research Hospital·Phase 2/3·NCT03117751·790 enrolled

Show 10 more trials

Treatment of Older Adults With Acute Lymphoblastic Leukemia

Completed·MMassachusetts General Hospital·Phase 2·NCT00973752·30 enrolled

Clofarabine and Cyclophosphamide Combination in Acute Lymphoblastic Leukemia Patients

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT00412243·51 enrolled

S0530 Cytarabine and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Completed·SSWOG Cancer Research Network·Phase 2·NCT00337168·36 enrolled

Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)

Completed· Sanofi logo

Sanofi·Phase 2·NCT00042341·60 enrolled

S0910 Epratuzumab, Cytarabine, and Clofarabine in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

Completed·SSWOG Cancer Research Network·Phase 2·NCT00945815·35 enrolled

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

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01132573·27 enrolled

Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia

Terminated·UUniversity of California, San Diego·Phase 1/2·NCT00983528·6 enrolled

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT02883049·5,949 enrolled

Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia

Completed·BBetta Pharmaceuticals Co., Ltd.·Phase 2·NCT02544789·44 enrolled

A Phase II Open-Label Study of High-Dose Cytarabine and Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Refractory or Relapsed Acute Lymphoblastic Leukemia

Completed·WWake Forest University Health Sciences·Phase 2·NCT01656031·39 enrolled

Acute Leukemia12 trials

Investigation of Clofarabine in Acute Leukemias

Completed·UUniversity of Texas·Phase 2·NCT00098033·64 enrolled

A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.

Completed· Sanofi logo

Sanofi·Phase 1/2·NCT00315705·50 enrolled

Clofarabine, Etoposide, and Mitoxantrone for Relapsed and Refractory Acute Leukemias

Terminated·MMilton S. Hershey Medical Center·Phase 1·NCT00882076·22 enrolled

Show 9 more trials

Bridging Study to Eliminate Presence of MRD for Acute Leukemia Before HCT

Terminated·MMedical College of Wisconsin·Phase 2·NCT02349178·6 enrolled

Phase I Dose-Escalation Trial of Clofarabine Followed by Escalating Doses of Fractionated Cyclophosphamide in Children With Relapsed or Refractory Acute Leukemias

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00852709·35 enrolled

Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT00462787·23 enrolled

Clofarabine, Idarubicin, Cytarabine, Vincristine Sulfate, and Dexamethasone in Treating Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT02135874·16 enrolled

Clofarabine, Cyclophosphamide and Etoposide for Minimal Residual Disease Positive Acute Leukemia

Withdrawn·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT01677949

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

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT01169012·13 enrolled

Mitoxantrone and Clofarabine for Treatment of Recurrent NHL or Acute Leukemia

Completed·NNew York Medical College·Phase 1/2·NCT01842672·41 enrolled

Fludarabine Phosphate, Clofarabine, and Busulfan With Vorinostat in Treating Patients With Acute Leukemia in Remission or Relapse Undergoing Donor Stem Cell Transplant

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02083250·70 enrolled

Decitabine Followed by Clofarabine, Idarubicin, and Cytarabine in Acute Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01794702·65 enrolled

Myelodysplastic Syndrome9 trials

Clofarabine for Myelodysplastic Syndrome (MDS) Patients Who Failed Vidaza Treatment (tx)

Terminated·—·Phase 2·NCT00700011·10 enrolled

Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm

Completed·UUniversity of Washington·Phase 2·NCT01101880·50 enrolled

Oral Clofarabine Study in Patients With Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00299156·65 enrolled

Show 6 more trials

Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01444742·81 enrolled

Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01289457·282 enrolled

Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00778375·122 enrolled

Clofarabine Plus Cytarabine in Patients With Previously Untreated Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00065143·60 enrolled

Clofarabine in High Risk Myelodysplastic Syndrome (MDS)

Completed·GGroupe Francophone des Myelodysplasies·Phase 1/2·NCT01063257·76 enrolled

Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT01471444·256 enrolled

Leukemia9 trials

A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

Completed· Sanofi logo

Sanofi·Phase 2·NCT00373529·116 enrolled

Phase II Study of Clofarabine in Adult Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Completed· Sanofi logo

Sanofi·Phase 2·NCT00044889·40 enrolled

A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)

Completed· Sanofi logo

Sanofi·Phase 3·NCT00317642·326 enrolled

Show 6 more trials

Phase II Study of Clofarabine in Pediatric Acute Myelogenous Leukemia (AML) Patients

Completed· Sanofi logo

Sanofi·Phase 2·NCT00042354·40 enrolled

Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03096782·6 enrolled

Clofarabine With Cytarabine for Patients With Minimal Residual Disease Positive Leukemia

Terminated·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 2·NCT01158885·2 enrolled

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

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT01160354·22 enrolled

Clofarabine and Low Dose Total Body Irradiation as a Preparative Regimen for Stem Cell Transplant in Leukemia.

Completed·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 1·NCT01041508·18 enrolled

T2007-002 Clofarabine, Etoposide, Cyclophosphamide in Relapsed Acute Myelogenous Leukemia (AML)

Terminated·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 2·NCT00939653·6 enrolled

50 more indications

Myelodysplastic Syndromes8 trials

Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Completed·TThe University of New South Wales·Phase 2/3·NCT00454480·2,000 enrolled

A Study of Oral Clofarabine in Adult Patients With Myelodysplastic Syndromes (MDS)

Terminated· Sanofi logo

Sanofi·Phase 1·NCT00750334·2 enrolled

Clofarabine Followed By Lenalidomide for High-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 1·NCT01629082·4 enrolled

Show 5 more trials

A Dose Confirmation Study of Oral Clofarabine for Adult Patients Previously Treated for Myelodysplastic Syndromes (MDS)

Completed· Sanofi logo

Sanofi·Phase 2·NCT00531232·38 enrolled

Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00088218·95 enrolled

Clofarabine and High-Dose Melphalan Followed by Donor Stem Cell Transplant in Patients With Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Myelodysplastic Syndromes

Completed·—·Phase 1·NCT00641030·20 enrolled

Decitabine and Clofarabine in Higher Risk Myelodysplastic Syndromes (MDS)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00903760·42 enrolled

Clofarabine, Cytarabine, and G-CSF in Treating Patients With Myelodysplastic Syndromes

Terminated·UUniversity of Nebraska·Phase 1/2·NCT00503880·2 enrolled

Stem Cell Transplant7 trials

Thiotepa-Clofarabine-Busulfan With Allogeneic Stem Cell Transplant for High Risk Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00857389·60 enrolled

Clofarabine, Melphalan, and Thiotepa Followed By a Donor Stem Cell Transplant in Treating Patients With High-Risk and/or Advanced Hematologic Cancer or Other Disease

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT00423514·38 enrolled

Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00617929·12 enrolled

Show 4 more trials

Allogeneic Stem Cell Transplant With Clofarabine, Ara-C and TBI for AML and ALL

Completed·NNew York Medical College·Phase 1/2·NCT00529360·32 enrolled

Reduced Intensity Conditioning With Clofarabine, Antithymocyte Globulin (ATG), Total Lymphoid Irradiation (TLI) Followed by Allogeneic Stem Cell Transplant

Completed·—·Phase 1·NCT00697684·29 enrolled

Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML

Terminated·MMilton S. Hershey Medical Center·Phase 2·NCT04002115·2 enrolled

Allogeneic Stem Cell Transplant for CLL

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT01629511·15 enrolled

Lymphoma6 trials

Dose Escalation Study of Clofarabine in Patients With Relapsed or Refractory Low Grade or Intermediate-Grade B-Cell Lymphoma

Completed·YYale University·Phase 1·NCT00338494·16 enrolled

Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL)

Completed·OOncology Specialists, S.C.·Phase 1/2·NCT00156013·33 enrolled

Clofarabine in Treating Patients With T-Cell or Natural Killer-Cell Non-Hodgkin's Lymphoma That Has Relapsed or Not Responded to Previous Treatment

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT00416351·29 enrolled

Show 3 more trials

A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkin's Lymphoma

Completed·OOhio State University Comprehensive Cancer Center·Phase 2·NCT00201669·6 enrolled

Clofarabine and Rituximab in Treating Patients With Relapsed Non-Hodgkin Lymphoma

Terminated·OOHSU Knight Cancer Institute·Phase 1/2·NCT00691652·2 enrolled

Oral Clofarabine for Relapsed/Refractory Non-Hodgkin Lymphoma

Completed·MMassachusetts General Hospital·Phase 1/2·NCT00644189·50 enrolled

Hematologic Malignancies5 trials

T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT01621477·34 enrolled

Sorafenib in Combination With Cytarabine and Clofarabine in Patients With Refractory or Relapsed Hematologic Malignancies

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT00908167·44 enrolled

Pilot Study of Haploidentical Natural Killer Cell Infusions for Poor Prognosis Non-AML Hematologic Malignancies

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT00697671·48 enrolled

Show 2 more trials

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

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT01119066·422 enrolled

Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01471067·33 enrolled

Chronic Lymphocytic Leukemia3 trials

Oral Clofarabine in Chronic Lymphocytic Leukemia (CLL)

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT00800566

Clofarabine in Chronic Lymphocytic Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00028418·100 enrolled

Study of Weekly Clofarabine for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT00081887·8 enrolled

Transplantation2 trials

Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation

Recruiting·NNantes University Hospital·Phase 2·NCT06252870·82 enrolled

Clofarabine, Cytarabine, and Thymoglobulin for Allogeneic Transplantation

Terminated·WWashington University School of Medicine·Phase 2·NCT00593645·7 enrolled

High Risk2 trials

Safety and Tolerability of Oral Clofarabine in Intermediate to High Risk Myelodysplastic Patients

Terminated·RRoswell Park Cancer Institute·Phase 1·NCT01003678·4 enrolled

HSCT for High Risk Inherited Inborn Errors

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00383448·38 enrolled

T-cell non-Hodgkin lymphoma2 trials

Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01701986·64 enrolled

Vorinostat and Combination Chemotherapy Before Donor Stem Cell Transplantation for the Treatment of Relapsed Aggressive B-cell or T-cell Non-Hodgkin Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT04220008

Acute Lymphoblastic Leukaemia2 trials

A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia

Completed· Sanofi logo

Sanofi·Phase 2·NCT00930098·74 enrolled

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

Completed· Sanofi logo

Sanofi·Phase 1·NCT01196013·7 enrolled

Hematopoietic Stem Cell Transplantation2 trials

Haploidentical Hematopoietic Stem Cell Transplantation Using A Novel Clofarabine Containing Conditioning Regimen For Patients With Refractory Hematologic Malignancies

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT00824135·34 enrolled

Uproleselan With Pre-Transplant Conditioning in Hematopoietic Stem Cell Transplantation for AML

Terminated·MMalika Kapadia·Phase 1·NCT05569512·1 enrolled

AML2 trials

Bisantrene Combination for Resistant AML

Unknown status·SSheba Medical Center·Phase 2·NCT04989335·29 enrolled

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

Completed·NNantes University Hospital·Phase 2·NCT01188174·26 enrolled

Bone Marrow Transplantation1 trial

Study of Clofarabine and Fludarabine Drug Exposure in Pediatric Bone Marrow Transplantation (HCT)

Completed·UUniversity of California, San Francisco··NCT03609814·30 enrolled

Hematologic Malignancy1 trial

Terminated·—·Phase 2·NCT01500161·1 enrolled

Older Patients1 trial

Clofarabine and Cytarabine in Treating Older Patients With AML or High-Risk MDS

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT00839982·35 enrolled

Refractory1 trial

Phase I Trial of Clofarabine in Combo w/ HD Etoposide & Cyclophosphamide and APBSCT for Pts w/ High-Risk or Refractory NHL

Completed·IIndiana University School of Medicine·Phase 1·NCT00477945·18 enrolled

Non-malignant Disorders1 trial

Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04644016·31 enrolled

Bone1 trial

Clofarabine Bone Marrow Cytoreduction

Completed·UUniversity of Chicago·Phase 2·NCT00724009·29 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Pilot Trial of Clofarabine Added to Standard Busulfan and Fludarabine for Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation

Terminated·UUniversity of California, San Francisco·Phase 2·NCT01596699·16 enrolled

Childhood Acute Lymphoblastic Leukemia1 trial

Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia

Completed·UUniversity Hospital, Lille·Phase 1·NCT01279096·20 enrolled

Relapsed or Refractory Hematologic Malignancies1 trial

Bendamustine Hydrochloride, Clofarabine, and Etoposide in Treating Younger Patients With Relapsed or Refractory Hematologic Malignancies

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT01900509·16 enrolled

Advanced Hematologic Malignancies1 trial

Clofarabine-Melphalan-Alemtuzumab Conditioning in Patients With Advanced Hematologic Malignancies

Completed·UUniversity of Chicago·Phase 1/2·NCT00943592·82 enrolled

Consolidation Therapy1 trial

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

Terminated·PPETHEMA Foundation·Phase 2·NCT01193400·75 enrolled

Crohn Disease1 trial

Phase 1b/2a Trial of Allogeneic HSCT From an HLA-partially Matched Related or Unrelated Donor After TCRab+ T-cell/CD19+ B-cell Depletion for Patients With Monogenic and/or Early-onset Medically Refractory Crohn Disease

Not yet recruiting·SStanford University·Phase 1/2·NCT06986382·14 enrolled

Children1 trial

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

Completed·UUniversitätsklinikum Hamburg-Eppendorf·Phase 2/3·NCT01228331·745 enrolled

Patients With Advanced Solid Tumors1 trial

Clofarabine in Adult Patients With Advanced Solid Tumors

Completed· Sanofi logo

Sanofi·Phase 1·NCT00125840

Refractory Solid Tumors1 trial

Study of Oral Clofarabine Administered Daily for 5 Days in Adult Patients With Refractory Solid Tumors

Completed· Sanofi logo

Sanofi·Phase 1·NCT00125827·24 enrolled

Hematopoietic Stem Cell Transplant1 trial

Reduced-Intensity Hematopoietic Stem Cell Transplant for High Risk Lysosomal and Peroxisomal Disorders

Completed·MMasonic Cancer Center, University of Minnesota·N/A·NCT01626092·3 enrolled

Pediatric1 trial

Vyxeos® With Clofarabine for Pediatric AML

Recruiting·PPrincess Maxima Center for Pediatric Oncology·Phase 1·NCT07156435·25 enrolled

Allogeneic Stem Cell Transplantation1 trial

Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation

Completed·MMassachusetts General Hospital·Phase 2·NCT01643668·34 enrolled

Multiple Myeloma1 trial

A Phase II Study of Clofarabine in Patients With Relapsed or Refractory Multiple Myeloma

Terminated·WWashington University School of Medicine·Phase 2·NCT00241371·8 enrolled

Chronic Myelomonocytic Leukemia1 trial

Low-dose Oral Clofarabine for the Treatment of IPSS INT-1, INT-2 or HIGH Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia

Terminated·UUniversity of Utah·Phase 1/2·NCT00708721·11 enrolled

Mesenchymal Stem Cells1 trial

Cord Blood Expansion on Mesenchymal Stem Cells

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00498316·98 enrolled

Urothelial Carcinoma1 trial

Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma

Recruiting·EEkaterina Laukhtina·Phase 1/2·NCT07034053·50 enrolled

Malignancies1 trial

A Phase I Trial of Myeloablative Conditioning w/ Clofarabine and HD Busulfan for Pts w/ Refractory Heme Malignancies Undergoing Allo PBSCT

Completed·IIndiana University School of Medicine·Phase 1·NCT00477542·18 enrolled

Acute Myeloid Leukaemia (AML)1 trial

Clofarabine Pre-conditioning With Allogeneic Transplant for Acute Myeloid Leukaemia (AML)

Completed·UUniversity Hospital Southampton NHS Foundation Trust·Phase 1/2·NCT01422603·9 enrolled

Efficacy1 trial

Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT

Recruiting·NNantes University Hospital·Phase 2·NCT05917405·302 enrolled

MDS1 trial

2 Arm Study of Clofarabine IV in MDS Patients

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00422032·60 enrolled

Lymphoblastic Lymphoma1 trial

NHL16: Study For Newly Diagnosed Patients With Acute Lymphoblastic Lymphoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01451515·23 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Busulfan Plus Clofarabine Followed by Allogeneic Hematopoietic Stem Cell Transplantation

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00990249·120 enrolled

T-cell acute lymphoblastic leukemia1 trial

Re-Induction Therapy for Relapsed Pediatric T-Cell Acute Lymphoblastic Leukemia or Lymphoma

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT02518750·3 enrolled

Stem Cell Transplantation1 trial

Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03615105·9 enrolled

Graft Versus Host Disease1 trial

Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC

Terminated·NNantes University Hospital·Phase 2·NCT03263767·47 enrolled

Precursor B-Cell Acute Lymphoblastic Leukemia1 trial

Therapy for Pediatric Relapsed or Refractory Precursor B-Cell Acute Lymphoblastic Leukemia and Lymphoma

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01700946·80 enrolled

Peripheral Blood Stem Cell Transplantation1 trial

TCR Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03615144·1 enrolled

Chronic Myelogenous Leukemia1 trial

Clofarabine and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Leukemia, Chronic Myelogenous Leukemia, or Myeloproliferative Disorders

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00293410·70 enrolled

Adult Acute Lymphoblastic Leukemia in Remission1 trial

Phase II Study of Clofarabine and High-Dose Melphalan Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation for Myelodysplasia or Acute Leukemia in Remission

Active, not recruiting·CCity of Hope Medical Center·Phase 2·NCT01885689·72 enrolled

Recurrent Acute Lymphoblastic Leukemia1 trial

Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT03136146·42 enrolled

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial

Personalized NK Cell Therapy in CBT

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT02727803·100 enrolled

Langerhans Cell Histiocytosis1 trial

Phase II Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders

Active, not recruiting·DDana-Farber Cancer Institute·Phase 2·NCT02425904·25 enrolled

Unspecified1 trial

Clofarabine for Langerhans in Pedi

Withdrawn·—·Phase 2·NCT01796405

Regulatory

FDA Approval Timeline[5]

Dec 28, 2004

CLOLAR

NDA NDA021673

Sources

References

[1]
ClinicalTrials.gov — 144 trial records for clofarabine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Clolar drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — clofarabine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for clofarabine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021673). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Genzyme, a Sanofi Company company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: DNA Polymerase (alpha/delta/epsilon) Inhibitor; Ribonucleoside-Diphosphate Reductase RR1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GGenzyme, a Sanofi Company

Clolar

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q3 2027

Q3 2028

Trials by Indication[1]

Acute Myeloid Leukemia21 trials

Acute Lymphoblastic Leukemia13 trials

Acute Leukemia12 trials

Myelodysplastic Syndrome9 trials

Leukemia9 trials

Myelodysplastic Syndromes8 trials

Stem Cell Transplant7 trials

Lymphoma6 trials

Hematologic Malignancies5 trials

Chronic Lymphocytic Leukemia3 trials

Transplantation2 trials

High Risk2 trials

T-cell non-Hodgkin lymphoma2 trials

Acute Lymphoblastic Leukaemia2 trials

Hematopoietic Stem Cell Transplantation2 trials

AML2 trials

Bone Marrow Transplantation1 trial

Hematologic Malignancy1 trial

Older Patients1 trial

Refractory1 trial

Non-malignant Disorders1 trial

Bone1 trial

Allogeneic Hematopoietic Cell Transplant1 trial

Childhood Acute Lymphoblastic Leukemia1 trial

Relapsed or Refractory Hematologic Malignancies1 trial

Advanced Hematologic Malignancies1 trial

Consolidation Therapy1 trial

Crohn Disease1 trial

Children1 trial

Patients With Advanced Solid Tumors1 trial

Refractory Solid Tumors1 trial

Hematopoietic Stem Cell Transplant1 trial

Pediatric1 trial

Allogeneic Stem Cell Transplantation1 trial

Multiple Myeloma1 trial

Chronic Myelomonocytic Leukemia1 trial

Mesenchymal Stem Cells1 trial

Urothelial Carcinoma1 trial

Malignancies1 trial

Acute Myeloid Leukaemia (AML)1 trial

Efficacy1 trial

MDS1 trial

Lymphoblastic Lymphoma1 trial

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

T-cell acute lymphoblastic leukemia1 trial

Stem Cell Transplantation1 trial

Graft Versus Host Disease1 trial

Precursor B-Cell Acute Lymphoblastic Leukemia1 trial

Peripheral Blood Stem Cell Transplantation1 trial

Chronic Myelogenous Leukemia1 trial

Adult Acute Lymphoblastic Leukemia in Remission1 trial

Recurrent Acute Lymphoblastic Leukemia1 trial

Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1 trial

Langerhans Cell Histiocytosis1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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