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Drug

Clofarabine

Approved · EMA
Emerging researchLate-stage development
Also known as CAFdA, Cl-F-Ara-A, Clolar, Clofarabin+3 more

CAFdA, Cl-F-Ara-A, Clolar, Clofarabin, Clofarabina, (2R,3R,4S,5R)-5-(6-amino-2-chloropurin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-ol, Clofarabinum.

RxNorm44151ChEMBLCHEMBL1750UNII762RDY0Y2H
2
Research papers
13
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-06-23Results posted · ClinicalTrials.gov

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

Clinical trial2026-06-17Results expected Q3 2026 · ClinicalTrials.gov

A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

Clinical trial2026-06-02Results posted · ClinicalTrials.gov

Personalized NK Cell Therapy in CBT

Clinical trial2026-05-22Results expected Q2 2027 · ClinicalTrials.gov

Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies

Clinical trial2026-05-14Results expected Q2 2030 · ClinicalTrials.gov

Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies and Non-malignant Disorders

Clinical trial2026-03-13Results expected Q4 2026 · ClinicalTrials.gov

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)

Clinical trial2026-02-17Results expected Q3 2027 · ClinicalTrials.gov

FLUCLORIC: Randomized Multicentric Phase III Study Comparing the Efficacy of 2 Reduced Intensity Conditioning Regimens (Clofarabine/Busulfan vs Fludarabine/Busulfan) in Adults With AML and Eligible to Allogeneic Stem Cell Transplantation

Clinical trial2026-01-30Results expected Q3 2028 · ClinicalTrials.gov

Market withdrawal: Ivozall (EMA)

Regulatory2023-10-18EMA

Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors.

Research2009-12-21Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Approval: Evoltra (EMA)

Regulatory2006-05-29EMA

Biochemical pharmacology and resistance to 2-chloro-2'-arabino-fluoro-2'-deoxyadenosine, a novel analogue of cladribine in human leukemic cells.

Research1999-09-01Clinical cancer research : an official journal of the American Association for Cancer Research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Clofarabine
Aliases & brands
CAFdACl-F-Ara-AClolarClofarabinClofarabina(2R,3R,4S,5R)-5-(6-amino-2-chloropurin-9-yl)-4-fluoro-2-(hydroxymethyl)oxolan-3-olClofarabinum
RxNorm CUI
44151
ChEMBL ID
CHEMBL1750
UNII
762RDY0Y2H
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2006-05-29
Latest approval
2006-05-29
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2023-10-18Market withdrawalMarket
Market withdrawal: Ivozall (EMA)
Indication: Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other… Show full indication

Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.

Evidence ↗
2006-05-29Approval
Approval: Evoltra (EMA)
Indication: Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other… Show full indication

Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

144 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
144
registered trials across all phases
LATEST COMPLETION 2026
13
Active studies
9
Recruiting
9
Late-stage (III+)
92
Completed
39
Discontinued
PHASE DISTRIBUTIONn = 144
Phase 138Phase 1 / 226Phase 271Phase 2 / 33Phase 35Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

Active, not recruitingPH II/IIISt. Jude Children's Research Hospitaln=7902028

A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

CompletedPH IIIKey trialNational Cancer Institute (NCI)n=5,9492026

A Randomized Multi-Center Treatment Study (COALL 08-09) to Improve the Survival of Children with Acute Lymphoblastic Leukemia on Behalf of the German Society of Pediatric Hematology and Oncology

CompletedPH II/IIIUniversitätsklinikum Hamburg-Eppendorfn=7452024

Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin &Amp; Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years)

CompletedPH IIIECOG-ACRIN Cancer Research Groupn=7272022

A Randomized Study of Once Daily Fludarabine-Clofarabine Versus Fludarabine Alone Combined With Intervenous Busulfan Followed by Allogeneic Hemopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

CompletedPH IIIM.D. Anderson Cancer Centern=2562020

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations

CompletedPH IIIKey trialNational Cancer Institute (NCI)n=5,9492026

A Randomized Multi-Center Treatment Study (COALL 08-09) to Improve the Survival of Children with Acute Lymphoblastic Leukemia on Behalf of the German Society of Pediatric Hematology and Oncology

CompletedPH II/IIIUniversitätsklinikum Hamburg-Eppendorfn=7452024

Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas

CompletedPH I/IIM.D. Anderson Cancer Centern=642024

A Reduced Intensity Conditioning With Clofarabine Antithymocyte Globulin and Total Lymphoid Irradiation Followed by Allogeneic Hematopoietic Stem Cell Transplantation

CompletedPH IBeth Israel Deaconess Medical Centern=292023

A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia

CompletedPH IIM.D. Anderson Cancer Centern=162023

Phase III Randomized Trial of Clofarabine as Induction and Post-Remission Therapy vs. Standard Daunorubicin &Amp; Cytarabine Induction and Intermediate Dose Cytarabine Post-Remission Therapy, Followed by Decitabine Maintenance vs. Observation in Newly-Diagnosed Acute Myeloid Leukemia in Older Adults (Age >/= 60 Years)

CompletedPH IIIECOG-ACRIN Cancer Research Groupn=7272022

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
19992010
Most influential

Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · 151 cites

Biochemical pharmacology and resistance to 2-chloro-2'-arabino-fluoro-2'-deoxyadenosine, a novel analogue of cladribine in human leukemic cells.

Clinical cancer research : an official journal of the American Association for Cancer Research · 1999 · 57 cites
Recent papers

Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2010 · 151 cites

Biochemical pharmacology and resistance to 2-chloro-2'-arabino-fluoro-2'-deoxyadenosine, a novel analogue of cladribine in human leukemic cells.

Clinical cancer research : an official journal of the American Association for Cancer Research · 1999 · 57 cites
Journals, researchers & institutions
Top journals
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Abichandani R1
  • Albertioni F1
  • Arellano M1
  • Claxton D1
  • Craig M1
  • Douer D1
  • Eckert S1
  • Erba HP1
Leading institutions
free-text, unnormalised
  • Clinical Pharmacology1
  • University of Texas M. D. Anderson Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.