Cladribine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Litak | — | 2004-04-14 | europa.eu ↗ |
| Approved | US (FDA) | LEUSTATIN | — | 1993-02-26 | fda.gov ↗ |
Trials 100 · started per year
Also used as a comparator or background therapy in 39 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT06007911 Background | Aug 2024 → Dec 2025 | acute myeloid leukemia | Medical College of Wisconsin | Withdrawn | No outcome recorded |
| Phase 1 | NCT06060782 Background | Mar 2024 → Aug 2026 overdue | Burkitt lymphoma, adult acute lymphoblastic leukemia, lymphoblastic lymphoma | Fifth Affiliated Hospital, Sun Yat-Sen University | Recruiting | No outcome recorded |
| Phase 1 | NCT05330377 Background | Mar 2023 → May 2027 | acute myeloid leukemia | Ayman H Qasrawi | Withdrawn | No outcome recorded |
| Phase 1 | NCT03491579 Background | Dec 2018 → Sep 2019 | acute myeloid leukemia | Insel Gruppe AG, University Hospital Bern | Withdrawn | No outcome recorded |
| Phase 1 | NCT03441048 Background | May 2018 → May 2024 | acute myeloid leukemia | Medical College of Wisconsin | Completed | No outcome recorded |
| Phase 1 | NCT01161550 Background | Nov 2010 → Aug 2011 | acute myeloid leukemia | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT00787969 Background | Apr 2009 → Apr 2012 | lymphoma | Alliance for Clinical Trials in Oncology | Completed | No outcome recorded |
| Phase 1 | NCT00258271 Background | Mar 2005 → Oct 2006 | leukemia | University of Rochester | Completed | No outcome recorded |
| Phase 1 | NCT00004904 Background | Oct 1999 → Jul 2000 | graft versus host disease, leukemia, myelodysplastic syndrome, myeloproliferative neoplasm +3 | Northwestern University | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT06965114 Comparator | May 2026 → Mar 2030 expected | hairy cell leukemia | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04797767 Background | Feb 2022 → Dec 2027 expected | acute biphenotypic leukemia, myeloid sarcoma | University of Washington | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03531918 Background | Sep 2018 → Jul 2021 | acute myeloid leukemia | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02728050 Background | Dec 2016 → Feb 2022 | acute biphenotypic leukemia, myelodysplastic syndrome | University of Washington | Completed | No outcome recorded |
| Phase 1/2 | NCT02921061 Background | Nov 2016 → Oct 2018 | mixed phenotype acute leukemia, myelodysplastic syndrome | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT02416908 Background | Jun 2015 → Jun 2019 | acute myeloid leukemia | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06660368 Background | Nov 2024 → Nov 2027 expected | acute myeloid leukemia | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT06561360 Comparator | Sep 2024 → Sep 2027 expected | hairy cell leukemia | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06084819 Comparator | Aug 2023 → Jan 2029 expected | acute myeloid leukemia | Chinese PLA General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03602131 Background | Jan 2019 → Dec 2020 | Hodgkins lymphoma, non-Hodgkin lymphoma | Sichuan University | Unknown | No outcome recorded |
| Phase 2 | NCT03589729 Background | Sep 2018 → Dec 2027 expected | Philadelphia-positive myelogenous leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, myelodysplastic syndrome, myeloid sarcoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT02756572 Background | Sep 2016 → Mar 2020 | acute myeloid leukemia, chronic myelomonocytic leukemia, high grade malignant neoplasm, myelodysplastic syndrome with excess blasts-2 | University of Washington | Completed | No outcome recorded |
| Phase 2 | NCT02250937 Background | Oct 2014 → Oct 2027 expected | acute myeloid leukemia, myelodysplastic syndrome | M.D. Anderson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT00955916 Background | Aug 2009 → Dec 2012 | leukemia | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04695080 Comparator | Jun 2021 → Dec 2027 expected | multiple sclerosis | Queen Mary University of London | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT02272478 Comparator | Oct 2014 → Feb 2021 | acute myeloid leukemia, myelodysplastic syndrome | Cardiff University | Unknown | No outcome recorded |
| Phase 311 trials | ||||||
| Phase 3 | NCT06713837 Comparator | Feb 2025 → Jan 2028 expected | acute myeloid leukemia | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS | Recruiting | No outcome recorded |
| Phase 3 | NCT04047628 Background | Dec 2019 → Oct 2026 expected | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 3 | NCT03926624 Comparator | Nov 2019 → Jan 2026 | acute myeloid leukemia | Delta-Fly Pharma, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT04121403 Comparator | Oct 2019 → Aug 2024 | multiple sclerosis | Oslo University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03477500 Comparator | Mar 2018 → Nov 2026 expected | multiple sclerosis | Haukeland University Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03257241 Comparator | Jul 2017 → Apr 2022 | acute myeloid leukemia | Polish Adult Leukemia Group | Unknown | No outcome recorded |
| Phase 3 | NCT02665065 Comparator | Jun 2016 → Jun 2022 overdue | acute myeloid leukemia | Actinium Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00718549 Background | Jul 2009 → Sep 2015 | B-cell chronic lymphocytic leukemia | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT00117598 Comparator | May 2005 → Aug 2007 | lymphoma | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00136084 Background | Aug 2002 → Jul 2008 | acute myeloid leukemia | St. Jude Children's Research Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00003746 Comparator | Sep 1998 → Nov 2005 | leukemia | Swiss Cancer Institute | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06763666 Background | Feb → Jun 2025 overdue | acute myeloid leukemia | Nanfang Hospital, Southern Medical University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT00198991 Background | Apr 2003 → Jun 2011 | adult acute lymphoblastic leukemia | Goethe University | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02676856 Background | Feb 2016 → Feb 2018 | acute myeloid leukemia | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 147 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cladribine | “For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).” NCT02676856 ↗130“The combination of VPA with fludarabine or 2-Chlorodeoxyadenosine (CdA, Cladribine) results in synergistic loss of B-CLL cell viability, and significant increase in apoptosis.” NCT01295593 ↗ “Daily administration of 2-chlorodeoxyadenosine (Cladribine, CDA) is a standard treatment for hairy cell leukemia, but may cause severe neutropenia and neutropenic fever.” PMID 19672771 ↗ Sep 2009 “Intensive chemotherapy Cladribine-cytarabine-etoposide -venetoclax sequential with fludarabine, busulfan and melphalan or fludarabine and total marrow irradiation” NCT05870995 ↗ “A Study of Cladribine, Low Dose Cytarabine, and Venetoclax in Treatment of Relapsed/Refractory or Secondary Acute Myeloid Leukemia” NCT07423104 ↗ “using MCBC as conditioning regimen, Mel 60mg/ m2 -9\~-8d, Cladribine 5 mg/m2 -9\~-5d, Bu3.2mg/kg -5\~-3d； Cy 30mg/kg -2\~-1 d” NCT06133556 ↗ “Cladribine: 5mg/m2 administered through a 2 hour intravenous infusion daily for 5 consecutive days starting on Day 2” NCT00594555 ↗ “Cladribine 5 mg/m2/day , cytarabine 20mg q12h, venetoclax 100mg d1, 200 d2, 400 mg/day from day 3 to day 21.” NCT05657639 ↗ “chemotherapy consisting of Cladribine (5mg/m2), cytarabine (1.5g/m2) and mitoxantrone （10mg/m2）for 5 days” NCT02910752 ↗ “Cladribine 5 mg/m2 IV daily for 5 consecutive days, every 28 days for 2-6 cycles depending on response,” NCT00117598 ↗ “Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan” NCT03882203 ↗ “Cladribine, 5 mg/m\^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2” NCT00955916 ↗ “including Cladribine 5mg/msq/d (d1-5), Ara-C 100mg/msq/d(d1-7) and IDA 8mg/msq/d (d1-3)” NCT02323022 ↗ “2-CdA (Cladribine) will be given through the catheter 24 hours a day on days 2 to 6.” NCT00483067 ↗ “Cladribine: 5mg/m2 IV over approximately 1 to 2 hours, daily on days 1-3.” NCT06532552 ↗ “cladribine - high dose cytarabine (2CDA+HDAraC)” NCT06713837 ↗ “Cladribine 5mg/m2 daily on days 1 - 5 inclusive” NCT02272478 ↗ “Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg” NCT02157181 ↗ “the nucleoside analog cladribine (2CdA)” NCT00656812 ↗ “Cladribine 5 mg/m² IV daily on Days 1-3” NCT07172204 ↗ “DAC (Daunorubicin + AraC + Cladribine)” PMID 31661339 ↗ Oct 2019 “Daunorubicin, Cladribine, Cytarabine” NCT03257241 ↗ “Cisplatin, Cladribine, Clofarabine” NCT02788201 ↗ “Ceritinib Cladribine Clofarabine” NCT02551718 ↗ “Cladribine(5mg/2,days 1-5)” NCT06084819 ↗ “cladribine (Mavenclad®)” NCT04047628 ↗ “Mavenclad (cladribine)” NCT03535298 ↗ “Cladribine (Leustatin)” NCT01513603 ↗ “Cladribine” NCT02665065 ↗ |
| Known as | 2-CdA | “Phase I will use 3 dose levels Level 1: caldribine (2-CdA) 3mg/m2 days 1-5; Level 2 caldribine 4mg/m2 days 1-5; Level 3: cladribine 5mg/m2 days 1-5” NCT01439750 ↗9“Here, we combined cytosine-arabinoside (Ara-C) and 2'-chlorodeoxyadenosine (2-CdA) with targeted therapy to achieve stable remission.” PMID 37216396 ↗ Sep 2023 “Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses” NCT00002879 ↗ “another purine analog, cladribine (2-CdA), is also able” NCT03257241 ↗ “cladribine (2-chlorodeoxyadenosine; 2-CdA)” NCT00004762 ↗ “the nucleoside analog cladribine (2CdA)” NCT00656812 ↗ |
| Known as | 2-chloro-2-deoxyadenosine | “For patients of the high-risk group, the administration of 2-chloro-2-deoxyadenosine (2-CDA) will be integrated in the first phase of consolidation to achieve an even higher...” NCT00111345 ↗ |
| Known as | 2-chlorodeoxyadenosine | “The combination of VPA with fludarabine or 2-Chlorodeoxyadenosine (CdA, Cladribine) results in synergistic loss of B-CLL cell viability, and significant increase in apoptosis.” NCT01295593 ↗9“Here, we combined cytosine-arabinoside (Ara-C) and 2'-chlorodeoxyadenosine (2-CdA) with targeted therapy to achieve stable remission.” PMID 37216396 ↗ Sep 2023 “Patients receive cladribine (2-chlorodeoxyadenosine; 2-CdA) daily for 5 days every 4 weeks for a maximum of 6 courses” NCT00002879 ↗ “2-Chlorodeoxyadenosine (2-CdA) and Cytarabine (Ara-C) in Idiopathic Hypereosinophilic Syndrome (HES)” NCT00483067 ↗ “cladribine (2-chlorodeoxyadenosine; 2-CdA)” NCT00004762 ↗ “2-CdA [Cladribine, 2-Chlorodeoxyadenosine]” NCT02072811 ↗ |
| Known as | CdA | “The combination of VPA with fludarabine or 2-Chlorodeoxyadenosine (CdA, Cladribine) results in synergistic loss of B-CLL cell viability, and significant increase in apoptosis.” NCT01295593 ↗3“the concentration-time course of cladribine (CdA) and its main metabolite 2-chloroadenine (CAde)” PMID 28255849 ↗ Oct 2017 “Hairy cell leukemia (HCL) is highly responsive to but not curable by cladribine (CdA).” NCT00923013 ↗ “2-chlorodeoxyadenosine (CDA) daily” NCT00003746 ↗ |
| Known as | CLAD | “Drug: Cladribine (CLAD)” NCT07032727 ↗1“Cladribine (CLAD)” NCT06561152 ↗ |
| Known as | Cladaribine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Known as | Cladribina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Known as | Cladribine (Leustatin) | “Cladribine (Leustatin)” NCT01513603 ↗ |
| Known as | cladribine (Mavenclad) | “cladribine (Mavenclad®)” NCT04047628 ↗ |
| Known as | Cladribine, Syn 2CdA, (LITAK) 0.14 mg/kg | “Cladribine, Syn 2CdA, (LITAK®) 0.14 mg/kg” NCT02157181 ↗ |
| Known as | CladT | “BACKGROUND AND OBJECTIVES: Cladribine tablets (CladT) represent an effective immune reconstitution therapy, administered in short treatment courses over two consecutive years.” PMID 39963134 ↗ Feb 20251“Cladribine tablets (CladT) preferentially reduce B and T lymphocyte levels.” PMID 35003076 ↗ Dec 2021 |
| Known as | Leustat | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Known as | Leustatin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Known as | Litak | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Known as | Mavenclad | “INTRODUCTION: Cladribine Tablets (MAVENCLAD®) selectively reduce absolute lymphocyte counts (ALCs) in patients with multiple sclerosis.” PMID 29992396 ↗ Mar 20196“Cladribine (MAVENCLAD®) 3.5mg/kg, administered as weight-adjusted 10mg tablets” NCT04695080 ↗ “Mavenclad oral cladribine tablets” NCT04121403 ↗ |
| Known as | Mavenclad (cladribine) | “Mavenclad (cladribine)” NCT03535298 ↗ |
| Known as | NSC-05014 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Known as | NSC-105014 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Known as | NSC-105014-F | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Known as | RWJ 26251 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1619 ↗ |
| Action | Inhibit | “anti-adenosine deaminase” NCT04254640 ↗ |
| Modality | Small molecule | “The purine nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA)” NCT00126321 ↗ |
| Route | Intravenous | “cladribine IV continuously” NCT00003174 ↗ |