55 completed, 27 unknown, 23 recruiting, 10 active not recruiting. 71 Phase 2, 33 Phase 1, 23 Phase 3, 11 Phase 4, 3 Not applicable.
Follow Cladribine: new trials by email Literature Review of Cladribine trials Research Report on Cladribine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase 1 Open-Label, Dose-Ranging Safety and Pharmacokinetics Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML) Cytarabine, Oral Cladribine - Acute Myeloid Leukemia (AML) | Phase 1 / Phase 2 | Not yet recruiting | M.D. Anderson Cancer Center | 58 | 2027-12-01 | 2026-08-25 |
| Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by HSCT for R/R AML. Sonrotoclax, cladribine, and standard-dose cytarabine - AML (Acute Myelogenous Leukemia, HSCT | Phase 1 / Phase 2 | Not yet recruiting | Institute of Hematology & Blood Diseases Hospital, China | 50 | 2026-09-01 | 2026-08-11 |
| The HIt HArd and hiT Early in Multiple Sclerosis Trial Sequential treatment with rituximab and cladribine - Relapsing-remitting Multiple Sclerosis | Phase 2 | Recruiting | Uppsala University | 60 | 2026-09-01 | 2026-10-22 |
| Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia Biospecimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy - Hairy Cell Leukemia, Recurrent Hairy Cell Leukemia | Phase 1 / Phase 2 | Recruiting | National Cancer Institute (NCI) | 84 | 2026-05-29 | 2026-07-31 |
| Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia Ruxolitinib, Cladribine, Venetoclax - T-cell Prolymphocytic Leukemia, Refractory T-Cell Prolymphocytic Leukemia | Phase 1 / Phase 2 | Recruiting | M.D. Anderson Cancer Center | 36 | 2026-04-28 | 2026-08-12 |
| Cladribine Tablets as an Exit Therapy Strategy Cladribine - Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis | Completed | University Hospital, Strasbourg, France | 450 | 2025-10-17 | 2026-10-06 | |
| Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations Olutasidenib, Cladribine (CLAD), Venetoclax - Targeted Therapy, IDH1-Mutated Malignancies | Phase 2 | Recruiting | M.D. Anderson Cancer Center | 68 | 2025-09-12 | 2026-10-05 |
| A Phase I Study Investigating the Combination of Cladribine, Low Dose Cytarabine and Sorafenib Alternating With Decitabine in Pediatric Relapsed and Refractory Acute Leukemias Cladribine, Cytarabine, Sorafenib - Refractory Acute Leukemia, Relapsed Acute Leukemia | Phase 1 | Withdrawn | M.D. Anderson Cancer Center | 2025-07-31 | 2025-08-06 | |
| Trial of Cladribine and Low-Dose Cytarabine (LoDAC) Alternating With Decitabine vs. Hypomethylating Agents (HMA) Plus Venetoclax as Frontline Therapy for AML or High-Grade MDS in Patients Unfit for Intensive Induction Cladribine, Cytarabine, Decitabine - Acute Myeloid Leukemia, Myelodysplastic Syndromes | Phase 2 | Withdrawn | University of Florida | 2025-04-01 | 2025-04-22 | |
| Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML Tagraxofusp, Cladribine (CLAD), Cytarabine - Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia | Phase 1 / Phase 2 | Recruiting | Stanford University | 20 | 2025-02-10 | 2026-04-14 |
| CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML Cladribine, Cytarabine, G-CSF - Relapsed/Refractory AML | Phase 4 | Not yet recruiting | Nanfang Hospital, Southern Medical University | 172 | 2025-02-01 | 2025-01-08 |
| Venetoclax in Combination With Cladribine and Cytarabine Alternating With Azacitidine Plus Venetoclax for the Treatment of Newly Diagnosed Monocytic AML and Active Signaling Mutated AML Azacitidine, Biospecimen Collection, Bone Marrow Aspiration - Acute Monocytic Leukemia, Acute Myeloid Leukemia | Phase 2 | Recruiting | OHSU Knight Cancer Institute | 40 | 2025-01-03 | 2026-09-16 |
| BCL2i CLAG-M in R/R Acute Myeloid Leukemia Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen, Venetoclax - Relapsed or Refractory Acute Myeloid Leukemia (AML) | Phase 2 | Recruiting | H. Lee Moffitt Cancer Center and Research Institute | 52 | 2024-11-26 | 2026-04-01 |
| A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) Vemurafenib, Obinutuzumab, Cladribine - Hairy Cell Leukemia | Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 86 | 2024-09-09 | 2026-09-09 |
| Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia Navitoclax Dose Level -1, Navitoclax Dose Level 0, Navitoclax Dose Level 1 - Relapsed Adult AML, Refractory AML | Phase 1 | Withdrawn | Medical College of Wisconsin | 2024-08-31 | 2024-08-13 | |
| Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) Placebo, Cladribine Low Dose, Cladribine High Dose - Generalized Myasthenia Gravis | Phase 3 | Recruiting | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 264 | 2024-06-25 | 2026-10-21 |
| Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine Thiotepa, cyclophosphamide, cladribine, and cytarabine conditioning regimen - Burkitt Lymphoma, Lymphoblastic Lymphoma, Adult | Phase 1 | Recruiting | Fifth Affiliated Hospital, Sun Yat-Sen University | 28 | 2024-03-06 | 2025-03-06 |
| Cladribine Venetoclax in Monocytic AML Cladribine, Venetoclax, Azacitidine - Acute Myeloid Leukemia | Phase 2 | Active not recruiting | University of Colorado, Denver | 10 | 2024-02-08 | 2026-08-25 |
| A Phase 1, Open-Label, Sequential Cross-over, Bioavailability/Bioequivalence Study to Compare the Pharmacokinetics of Oral Cladribine With the Reference Listed Drug, Intravenous Cladribine Cladribine - Leukemia, Myelodysplastic Syndromes | Phase 1 | Terminated | M.D. Anderson Cancer Center | 3 | 2023-10-09 | 2026-07-30 |
| Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA) Mavenclad - Multiple Sclerosis | Active not recruiting | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | 366 | 2023-08-03 | 2026-08-07 |
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Leukemia, Myeloid, Acute (48) · Multiple Sclerosis (22) · Leukemia (14) · Myelodysplastic Syndromes (13) · Lymphoma (11) · Recurrence (11) · Leukemia, Biphenotypic, Acute (9) · Multiple Sclerosis, Relapsing-Remitting (9) · Precursor Cell Lymphoblastic Leukemia-Lymphoma (9) · Leukemia, Lymphocytic, Chronic, B-Cell (8) · Blast Crisis (7) · Leukemia, Hairy Cell (6) · Lymphoma, Mantle-Cell (6) · Leukemia, Monocytic, Acute (5) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (4)
M.D. Anderson Cancer Center (19) · EMD Serono Research & Development Institute, Inc. (5) · Fred Hutchinson Cancer Center (5) · University of Washington (5) · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (4) · Merck KGaA, Darmstadt, Germany (4) · Alliance for Clinical Trials in Oncology (3) · Medical College of Wisconsin (3) · National Cancer Institute (NCI) (3) · Sichuan University (3) · Sun Yat-sen University (3) · Children's Oncology Group (2) · Goethe University (2) · H. Lee Moffitt Cancer Center and Research Institute (2) · OHSU Knight Cancer Institute (2)
United States (73) · China (16) · Poland (13) · Germany (12) · Italy (9) · Canada (8) · France (8) · Switzerland (8) · United Kingdom (8) · Australia (7) · Austria (7) · Czechia (7) · Spain (7) · Sweden (7) · Belgium (6)
Roland Walter (4) · David J. Inwards, MD (3) · Tapan Kadia, MD (3) · Tapan M Kadia (3) · Anna Halpern (2) · Chun Wang, M.D.,Ph. D. (2) · Dieter Hoelzer, MD, PhD (2) · Reinhard Zenhaeusern, MD (2) · Uday R Popat (2) · Anne Kristine Lehmann, MD, PhD (1) · Astrid Kittang, MD, PhD (1) · Ayad M. Al-Katib, MD, FACP (1) · Ayman Qasrawi, MD (1)
PMID 32447743, PMID 35003076, PMID 33969750, PMID 34370275, PMID 35019731, PMID 36017780, PMID 36017797, PMID 40756532, PMID 41943490, PMID 18083847, PMID 18182574, PMID 18571721, PMID 19144982, PMID 19242495, PMID 19672771, PMID 20089960, PMID 20218808, PMID 20451454, PMID 21480469, PMID 21821712, PMID 22017519, PMID 22442346, PMID 22493293, PMID 22512017, PMID 23024237, PMID 23538338, PMID 23704089, PMID 24488798, PMID 24502830, PMID 25057177, PMID 26814618, PMID 27269945, PMID 27561722, PMID 28140753, PMID 28255849, PMID 28751559, PMID 28817997, PMID 29051829, PMID 29056470, PMID 29399054, PMID 29702001, PMID 29992396, PMID 30027104, PMID 30115541, PMID 31177537, PMID 31279288, PMID 31645648, PMID 31661339, PMID 32077361, PMID 32109194
P30CA015704 (6), 2017 (3), 2018 (2), P30CA016672 (2), 2008 (1), 2023 (1), P30CA022453 (1), P30CA023074 (1), P30CA069533 (1), R01CA113482 (1), UM1AI109565 (1), UM1CA186712 (1)