Drugs / Clofarabine
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Clofarabine

Other / unclassified

Developed for
acute myeloid leukemia · myelodysplastic syndrome · leukemia · acute lymphoblastic leukemia · chronic myeloid leukemia · chronic myelomonocytic leukemia · Hodgkins lymphoma · acute myeloid leukemia with 11q23 abnormalities
+73 more · acute myeloid leukemia with t(8;21)(q22;q22) translocation · chronic lymphocytic leukemia/small lymphocytic lymphoma · lymphoma · plasma cell myeloma · acute myeloid leukemia with abnormal bone marrow eosinophils inv(16)(p13q22) or t(16;16)(p13;q22) · Burkitt lymphoma · non-Hodgkin lymphoma · acute promyelocytic leukemia · adult acute lymphoblastic leukemia · childhood acute lymphoblastic leukemia · childhood acute myeloid leukemia · Langerhans cell histiocytosis · lymphoblastic lymphoma · acute biphenotypic leukemia · acute leukemia · B-cell chronic lymphocytic leukemia · cancer · diffuse large B-cell lymphoma · hematopoietic and lymphoid cell neoplasm · juvenile myelomonocytic leukemia · myeloproliferative neoplasm · urothelial carcinoma · acute erythroid leukemia · acute leukemia of ambiguous lineage · acute megakaryoblastic leukemia in adult · acute myeloblastic leukemia with maturation · acute myeloblastic leukemia without maturation · acute myeloid leukemia with minimal differentiation · acute myeloid leukemia with multilineage dysplasia · acute myeloid leukemia, del(5q31-q32) · acute myeloid leukemia, t(16;16)(p13.1;q22) · acute myelomonocytic leukemia M4 · acute undifferentiated leukemia · adult acute monocytic leukemia · anaplastic large cell lymphoma · anemia · angioimmunoblastic T-cell lymphoma · aplastic anemia · atypical chronic myeloid leukemia, BCR-ABL1 negative · B-cell acute lymphoblastic leukemia · B-cell neoplasm · B-cell non-Hodgkin lymphoma · bilineal acute myeloid leukemia · bone marrow failure syndrome · childhood leukemia · follicular lymphoma · hematopoietic and lymphoid system neoplasm · high grade B-cell lymphoma · high-grade B-cell lymphoma double-hit/triple-hit · immune dysregulation, autoimmunity, and autoinflammation · immunodeficiency disease · lymphoplasmacytic lymphoma · lymphoproliferative syndrome · mantle cell lymphoma · marginal zone lymphoma · metabolic disease · mixed phenotype acute leukemia, B/myeloid · mixed phenotype acute leukemia,T/myeloid · myelodysplastic syndrome associated with isolated del(5q) · myelodysplastic syndrome with excess blasts · myelodysplastic/myeloproliferative disease · myelodysplastic/myeloproliferative neoplasm · myelofibrosis · myeloid leukemia · myeloid neoplasm · peripheral T-cell lymphoma, not otherwise specified · premalignant hematological system disease · refractory plasma cell neoplasm · T-cell non-Hodgkin lymphoma · urinary bladder cancer · B-cell childhood acute lymphoblastic leukemia · hematologic disorder · lymphoid leukemia
Investigated by
Genzyme, a Sanofi Company · National Cancer Institute (NCI) · M.D. Anderson Cancer Center · Memorial Sloan Kettering Cancer Center · Nantes University Hospital · St. Jude Children's Research Hospital
+94 more · Dana-Farber Cancer Institute · University of Washington · Fred Hutchinson Cancer Center · GIMEMA Foundation · Masonic Cancer Center, University of Minnesota · Massachusetts General Hospital · Milton S. Hershey Medical Center · Therapeutic Advances in Childhood Leukemia Consortium · Washington University School of Medicine · Baylor Research Institute · Beth Israel Deaconess Medical Center · Bioenvision · City of Hope Medical Center · Hannover Medical School · Hospices Civils de Lyon · Indiana University · New York Medical College · Roswell Park Cancer Institute · SWOG Cancer Research Network · Sanofi · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · UNC Lineberger Comprehensive Cancer Center · University of Chicago · University of Michigan Rogel Cancer Center · Wake Forest University Health Sciences · American Family Children's Hospital · Ann & Robert H Lurie Children's Hospital of Chicago · Assisi Foundation · Assistance Publique - Hôpitaux de Paris · Bayer/Onyx · Betta Pharmaceuticals Co., Ltd. · Brigham and Women's Hospital · Celgene Corporation · Central Hospital, Nancy, France · Centre Hospitalier Universitaire de Besancon · Children's Oncology Group · Cookies for Kids' Cancer · ECOG-ACRIN Cancer Research Group · Eisai Inc. · Ekaterina Laukhtina · Enzon Pharmaceuticals, Inc. · European Organisation for Research and Treatment of Cancer - EORTC · Fondazione Italiana Sindromi Mielodisplastiche-ETS · Gaslini Institute · Groupe Francophone des Myelodysplasies · Institute of Hematology & Blood Diseases Hospital, China · Jazz Pharmaceuticals · Loyola University · Lund University Hospital · Medexus Pharma, Inc. · Medical College of Wisconsin · National Heart, Lung, and Blood Institute (NHLBI) · National University of Singapore · Nationwide Children's Hospital · North American Consortium for Histiocytosis · Northwestern University · Novartis Pharmaceuticals · OHSU Knight Cancer Institute · Ohio State University Comprehensive Cancer Center · Oncology Specialists, S.C. · Otsuka Pharmaceutical Development & Commercialization, Inc. · PETHEMA Foundation · Princess Maxima Center for Pediatric Oncology · Racura Oncology Ltd · Rennes University Hospital · Rush University Medical Center · Saint-Louis Hospital, Paris, France · Sheba Medical Center · Spanish Cooperative Group for the Study and Treatment of Acute Leukemias and Myelodysplasias · Spectrum Pharmaceuticals, Inc · St. Baldrick's Foundation · Targazyme, Inc. · Technical University Dresden · Texas Oncology Cancer Center · all 100 on the full record

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) CLOLAR — 2008-10-17 – 2022-07-18 fda.gov ↗
Approved EU (EMA) Evoltra — 2006-05-29 europa.eu ↗
Approved US (FDA) CLOLAR — 2004-12-28 fda.gov ↗

Trials 146 · started per year

today
US approved 2004
EU approved 2006
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199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 134 trials
Phase 1 NCT07156435 Nov 2020 → Dec 2026 expected childhood acute myeloid leukemia Princess Maxima Center for Pediatric Oncology Recruiting No outcome recorded
Phase 1 NCT02211755 Oct 2014 → Aug 2025 lymphoma, myelodysplastic syndrome National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT01629082 Jun 2012 → Oct 2015 acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome, neutropenia National Heart, Lung, and Blood Institute (NHLBI) Completed No outcome recorded
Phase 1 NCT01065545 Jun 2011 → ? acute myeloid leukemia Northwestern University Withdrawn No outcome recorded Stop: Business
Phase 1 NCT01169012 Sep 2010 → Apr 2012 acute lymphoblastic leukemia, acute myeloid leukemia, chronic myelomonocytic leukemia, myelodysplastic syndrome UNC Lineberger Comprehensive Cancer Center Completed No outcome recorded
Phase 1 NCT01196013 Aug 2010 → May 2011 acute lymphoblastic leukemia Genzyme, a Sanofi Company Completed No outcome recorded
Phase 1 NCT01132573 Apr 2010 → Jun 2014 acute biphenotypic leukemia, adult acute lymphoblastic leukemia National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT01090167 Feb 2010 → Apr 2011 acute myeloid leukemia Genzyme, a Sanofi Company Completed No outcome recorded
Phase 1 NCT01041508 Jan 2010 → Aug 2014 acute lymphoblastic leukemia, acute myeloid leukemia Therapeutic Advances in Childhood Leukemia Consortium Completed No outcome recorded
Phase 1 NCT01279096 Jan 2010 → Jun 2012 acute lymphoblastic leukemia University Hospital, Lille Completed No outcome recorded
Phase 1/228 trials
Phase 1/2 NCT07034053 Oct 2023 → Nov 2028 expected urothelial carcinoma Ekaterina Laukhtina Recruiting No outcome recorded
Phase 1/2 NCT02053545 Dec 2013 → May 2017 leukemia, lymphoma, myelodysplastic syndrome Ann & Robert H Lurie Children's Hospital of Chicago Withdrawn No outcome recorded Stop: Enrollment
Phase 1/2 NCT01983761 Nov 2013 → Mar 2014 Hodgkins lymphoma, disease related to transplantation, leukemia, myelodysplastic syndrome +1 Targazyme, Inc. Unknown No outcome recorded
Phase 1/2 NCT01842672 Mar 2013 → Aug 2021 Burkitt lymphoma, acute lymphoblastic leukemia, acute myeloid leukemia, diffuse large B-cell lymphoma +1 New York Medical College Completed No outcome recorded
Phase 1/2 NCT01794702 Feb 2013 → Jan 2018 acute leukemia M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1/2 NCT01534702 Jan 2012 → Apr 2013 acute myeloid leukemia Hannover Medical School Unknown No outcome recorded
Phase 1/2 NCT01289457 Feb 2011 → Jun 2017 leukemia M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1/2 NCT01422603 Feb 2011 → May 2014 acute myeloid leukemia, myelodysplastic syndrome University Hospital Southampton NHS Foundation Trust Completed No outcome recorded
Phase 1/2 NCT01160354 Aug 2010 → Mar 2016 acute myeloid leukemia M.D. Anderson Cancer Center Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT01063257 Apr 2010 → Mar 2014 myelodysplastic syndrome Groupe Francophone des Myelodysplasies Completed No outcome recorded
Phase 275 trials · 3 met primary
Phase 2 NCT07022834 Jun 2025 → Jun 2028 expected Langerhans cell histiocytosis West China Second University Hospital Recruiting No outcome recorded
Phase 2 NCT06252870 Jul 2024 → Oct 2027 expected graft versus host disease, hematopoietic and lymphoid cell neoplasm Nantes University Hospital Recruiting No outcome recorded
Phase 2 NCT05917405 Sep 2023 → Sep 2028 expected acute myeloid leukemia Nantes University Hospital Recruiting No outcome recorded
Phase 2 NCT04994808 Aug 2023 → Jan 2026 overdue acute myeloid leukemia, myelodysplastic syndrome Fred Hutchinson Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04220008 Oct 2021 Burkitt lymphoma, T-cell non-Hodgkin lymphoma, high grade B-cell lymphoma M.D. Anderson Cancer Center Withdrawn No outcome recorded Stop: Enrollment
Phase 2 NCT04989335 Aug 2021 → Dec 2024 acute myeloid leukemia Sheba Medical Center Unknown No outcome recorded
Phase 2 NCT04761770 Feb 2021 → Feb 2027 expected atypical chronic myeloid leukemia, BCR-ABL1 negative, chronic myelomonocytic leukemia, myelodysplastic syndrome Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04002115 Jun 2020 → Aug 2022 acute myeloid leukemia Milton S. Hershey Medical Center Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03615105 Jul 2018 → Mar 2024 Hodgkins lymphoma, acute myeloid leukemia, chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic myeloid leukemia Memorial Sloan Kettering Cancer Center Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT03136146 Aug 2017 → Aug 2027 expected B-cell acute lymphoblastic leukemia, Burkitt lymphoma, high-grade B-cell lymphoma double-hit/triple-hit M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT01385891 Aug 2008 → Dec 2009 acute leukemia Gaslini Institute Completed No outcome recorded
Phase 2/3 NCT00454480 Aug 2006 → Aug 2012 leukemia, myelodysplastic syndrome The University of New South Wales Completed No outcome recorded
Phase 35 trials · 2 missed
Phase 3 NCT05477589 Jun 2022 → Dec 2029 expected acute myeloid leukemia, disease related to hematopoietic stem cell transplant Vastra Gotaland Region Recruiting No outcome recorded
Phase 3 NCT02883049 Feb 2012 → Dec 2022 B-lymphoblastic leukemia/lymphoma, BCR-ABL1–like, central nervous system leukemia, testicular leukemia National Cancer Institute (NCI) Completed Missed primary
Phase 3 NCT01471444 Nov 2011 → Dec 2020 disease related to hematopoietic stem cell transplant, leukemia M.D. Anderson Cancer Center Completed No outcome recorded
Phase 3 NCT02085408 Feb 2011 → Feb 2021 acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation +9 ECOG-ACRIN Cancer Research Group Completed No outcome recorded
Phase 3 NCT00317642 Aug 2006 → Jan 2012 acute myeloid leukemia Genzyme, a Sanofi Company Completed Missed primary
Phase not applicable2 trials
— NCT07644481 Jul 2026 → Dec 2029 expected acute myeloid leukemia, disease related to hematopoietic stem cell transplant Institute of Hematology & Blood Diseases Hospital, China Not yet recruiting No outcome recorded
— NCT02551718 Sep 2015 → Jun 2020 acute leukemia of ambiguous lineage, acute lymphoblastic leukemia University of Washington Completed No outcome recorded
Comparator or background therapy29 trials
Phase 1 NCT05569512 Background Oct 2022 → Oct 2023 acute myeloid leukemia, childhood malignant neoplasm Malika Kapadia Terminated No outcome recorded
Phase 1 NCT02083250 Background Mar 2014 → Nov 2021 acute lymphoblastic leukemia, acute myeloid leukemia, disease related to hematopoietic stem cell transplant, myelodysplastic syndrome M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT01900509 Background Aug 2013 → May 2016 Hodgkins lymphoma, acute leukemia, non-Hodgkin lymphoma St. Jude Children's Research Hospital Completed No outcome recorded
Phase 1 NCT01471067 Background Jul 2012 → Apr 2017 disease related to hematopoietic stem cell transplant, leukemia, lymphoma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1 NCT01031368 Background Dec 2009 → Sep 2012 acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation, acute myeloblastic leukemia without maturation +9 Nohla Therapeutics, Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2016-03-09 Zydus Lifesciences Limited Regulatory Zydus receives tentative approval from the USFDA for Clofarabine Injection zyduslife.com ↗
Zydus Cadila has received the tentative approval from the USFDA to market Clofarabine Injection 20mg/20ml vials.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 178 sources stand behind the page.

FieldValueCited text
Known as Clofarabine “Clofarabine as a single agent as recommended in the prescribing information or clofarabine-based regimens with 20 mg/m²/day for up to 5 days.” NCT02013167 ↗
174

“Clofarabine is a second generation nucleoside analog FDA approved for the treatment of relapsed and refractory pediatric ALL” NCT00983528 ↗

“Clofarabine, Melphalan,Thiotepa, Cyclophosphamide, Mesna, Tacrolimus and mycophenolate mofetil (MMF)” NCT02053545 ↗

“Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine” NCT04761770 ↗

“Clofarabine is designed to interfere with the growth and development of cancer cells.” NCT01794702 ↗

“Clofarabine 30 mg/M2 -8 through - 4 (5 doses) infusion.” NCT00626626 ↗

“Clofarabine 30 mg/m2/day IV (2h) on days 2 to 6” NCT00932412 ↗

“Cladribine, Clofarabine, Crizotinib” NCT02788201 ↗

“Cladribine Clofarabine Crizotinib” NCT02551718 ↗

“clofarabine and cyclophosphamide” NCT04727151 ↗

“Clofarabine” NCT02665065 ↗

Show 164 more sources

Known as CLO “Patients were randomly assigned to receive either clofarabine (Clo) 40 mg/m(2) or a placebo followed by Ara-C 1 g/m(2) for five consecutive days.” PMID 22585697 ↗ May 2012
2

“The authors of this report investigated the safety and efficacy of clofarabine (CLO) in these patients.” PMID 21425150 ↗ Nov 2010

“Followed by infusion of Clofarabine (Clo) at 30 mg/m2 over 60 minutes” NCT04989335 ↗

Known as Clofarabina ChEMBL registry synonym — accepted as the source's own label CHEMBL1750 ↗
Known as Clofarabine (2-chloro-9-[2-deoxy-2-fluoro-D-arabinofuranosyl]adenine; Cl-F-ara A; CAFdA “Clofarabine (2-chloro-9-[2-deoxy-2-fluoro-D-arabinofuranosyl]adenine; Cl-F-ara A; CAFdA” NCT00708721 ↗
Known as Clolar ChEMBL registry synonym — accepted as the source's own label CHEMBL1750 ↗
Known as Clolar (intravenous clofarabine) “Clolar (intravenous clofarabine)” NCT01169012 ↗
Known as Evoltra ChEMBL registry synonym — accepted as the source's own label CHEMBL1750 ↗
Known as Ivozall ChEMBL registry synonym — accepted as the source's own label CHEMBL1750 ↗
Known as NSC-759857 ChEMBL registry synonym — accepted as the source's own label CHEMBL1750 ↗
Known as tradename EU = Evoltra “tradename EU = Evoltra” NCT00924443 ↗
Known as tradename US = Clolar “tradename US = Clolar” NCT00924443 ↗
Known as ◦Drug: Clofarabine “◦Drug: Clofarabine” NCT01983761 ↗
Action Inhibit “Mechanisms of action include inhibition of DNA synthesis, inhibition of DNA polymerases, and potent inhibition of ribonucleotide reductase (RNR) resulting in depletion of...” NCT00065143 ↗
Modality Other / unclassified “synthesized hybrid nucleoside analog” NCT00028418 ↗
Route Intravenous “clofarabine (IV formulation)” NCT00042341 ↗