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DRUG CLASS:

Purinergic receptor P1 agonist

16h
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2) (clinicaltrials.gov)
P=N/A, N=295, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Jan 2025 --> May 2025 | Trial primary completion date: Jan 2025 --> May 2025
Trial completion date • Trial primary completion date
3d
Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) (clinicaltrials.gov)
P3, N=267, Completed, Oslo University Hospital | Recruiting --> Completed | Trial completion date: Dec 2024 --> Aug 2024
Trial completion • Trial completion date • Head-to-Head
|
GFAP (Glial Fibrillary Acidic Protein)
17d
Cladribine Tablets After Treatment With Natalizumab (CLADRINA) (clinicaltrials.gov)
P4, N=40, Active, not recruiting, University of Texas Southwestern Medical Center | Trial primary completion date: Aug 2024 --> Aug 2026
Trial primary completion date
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ITGAX (Integrin Subunit Alpha X)
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Tysabri (natalizumab)
2ms
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2) (clinicaltrials.gov)
P=N/A, N=295, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Nov 2026 --> Jan 2025
Trial completion date
2ms
Expression and prognostic impact of VDAC3 in colorectal adenocarcinoma. (PubMed, Transl Cancer Res)
Finally, analysis of the CellMiner database predicted that VDAC3 expression was positively correlated with chelerythrine and cladribine, but negatively correlated with Ergenyl. Our study suggests that VDAC3 may be a potential biomarker for early diagnosis, prognosis, and treatment of COAD.
Journal
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VDAC3 (Voltage Dependent Anion Channel 3)
|
cladribine
2ms
A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS) (clinicaltrials.gov)
P=N/A, N=102, Completed, EMD Serono Research & Development Institute, Inc. | Active, not recruiting --> Completed | Trial completion date: Feb 2026 --> Mar 2024 | Trial primary completion date: Feb 2026 --> Mar 2024
Trial completion • Trial completion date • Trial primary completion date
3ms
Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS) (clinicaltrials.gov)
P=N/A, N=256, Completed, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Active, not recruiting --> Completed
Trial completion
3ms
Cladribine Venetoclax in Monocytic AML (clinicaltrials.gov)
P2, N=40, Recruiting, University of Colorado, Denver | Not yet recruiting --> Recruiting | Initiation date: Dec 2024 --> Feb 2024
Enrollment open • Trial initiation date
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Venclexta (venetoclax)
4ms
Venetoclax-Navitoclax With Cladribine-based Salvage Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=0, Withdrawn, Medical College of Wisconsin | N=36 --> 0 | Initiation date: May 2024 --> Aug 2024 | Not yet recruiting --> Withdrawn
Enrollment change • Trial initiation date • Trial withdrawal
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Venclexta (venetoclax) • cytarabine • navitoclax (ABT 263) • mitoxantrone • Neupogen (filgrastim)
5ms
DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov)
P4, N=800, Active, not recruiting, The Cleveland Clinic | Trial primary completion date: Apr 2030 --> Jul 2027
Trial primary completion date
|
Rituxan (rituximab) • Briumvi (ublituximab-xiiy) • fingolimod • Lemtrada (alemtuzumab) • Ocrevus (ocrelizumab) • Tysabri (natalizumab)
5ms
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) (clinicaltrials.gov)
P3, N=240, Recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Trial completion date: Feb 2031 --> Jul 2030 | Trial primary completion date: Feb 2029 --> May 2028
Trial completion date • Trial primary completion date
6ms
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) (clinicaltrials.gov)
P3, N=240, Recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Not yet recruiting --> Recruiting
Enrollment open
6ms
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) (clinicaltrials.gov)
P3, N=240, Not yet recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
New P3 trial
6ms
ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis (clinicaltrials.gov)
P2/3, N=200, Recruiting, Queen Mary University of London | Phase classification: P2b --> P2/3
Phase classification • HEOR • Metastases
6ms
Lintuzumab-Ac225 in Combination With Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=26, Completed, Medical College of Wisconsin | Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> May 2024
Trial completion • Trial completion date • Combination therapy
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cytarabine • mitoxantrone • Actimab-A (lintuzumab-Ac225) • Depocyte (liposomal cytarabine)
7ms
Pharmacological modulation of inflammatory oligodendrocyte progenitor cells using three multiple sclerosis disease modifying therapies in vitro. (PubMed, Neurotherapeutics)
We tested the effects of cladribine (CDB), dimethylfumarate (DMF), and interferon-beta (IFN-β), existing anti-inflammatory therapies for MS, on the IFN-γ-induced iOPC formation and OPC differentiation block...We conclude that promoting proliferation and differentiation and suppressing iOPC induction under inflammatory conditions may require separate therapeutic strategies and must be balanced for maximal repair. Our in vitro MHC screening assay can be leveraged across cell types to test the effects of drug candidates and disease-related stimuli.
Preclinical • Journal
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IFNG (Interferon, gamma) • IFNB1 (Interferon Beta 1)
7ms
Trial completion
|
cytarabine • idarubicin hydrochloride • cladribine
7ms
Oral Cladribine B-cell Study (clinicaltrials.gov)
P=N/A, N=10, Completed, Queen Mary University of London
New trial
|
CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • IL10 (Interleukin 10) • CCR7 (Chemokine (C-C motif) receptor 7) • CD24 (CD24 Molecule) • CD27 (CD27 Molecule) • MME (Membrane Metalloendopeptidase) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
7ms
Real-world data on diagnostics, treatment and outcomes of patients with hairy cell leukemia: The HCL-CLLEAR study. (PubMed, Hematol Oncol)
These data confirm an excellent prognosis for HCL patients treated with cladribine-based therapy. On the contrary, HCLv with its aggressive behavior represents a group of patients in whom novel treatment approaches are needed.
Retrospective data • Journal • Real-world evidence • Real-world
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BRAF (B-raf proto-oncogene)
|
BRAF V600E
|
cladribine
8ms
DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov)
P4, N=800, Active, not recruiting, The Cleveland Clinic | Recruiting --> Active, not recruiting
Enrollment closed
|
Rituxan (rituximab) • Briumvi (ublituximab-xiiy) • fingolimod • Lemtrada (alemtuzumab) • Ocrevus (ocrelizumab) • Tysabri (natalizumab)
8ms
Extension to the MAGNIFY MS Trial on Mavenclad® (Magnify MS Extension) (clinicaltrials.gov)
P4, N=219, Completed, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Active, not recruiting --> Completed | Trial completion date: Feb 2024 --> Sep 2023
Trial completion • Trial completion date
9ms
Journal • Combination therapy
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CD34 (CD34 molecule)
|
cyclophosphamide • cladribine • busulfan
10ms
Sustained effects on immune cell subsets and autoreactivity in multiple sclerosis patients treated with oral cladribine. (PubMed, Front Immunol)
Furthermore, we observed reduced T cell responses to autoantigens possibly presented by B cells (RASGRP2 and a-B crystallin (CRYAB)) at W52 and W96 and a further reduction in responses to the myelin antigens myelin basic protein (MBP) and myelin oligodendrocyte glycoprotein (MOG) after 96 weeks. We conclude that the effects of cladribine observed after year one are maintained and, for some effects, even increased two years after the initiation of a full course of treatment with cladribine tablets.
Journal • Immune cell
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CRYAB (Crystallin Alpha B)
10ms
Cladribine Venetoclax in Monocytic AML (clinicaltrials.gov)
P2, N=40, Not yet recruiting, University of Colorado, Denver
New P2 trial
|
Venclexta (venetoclax)
11ms
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
P2, N=160, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2025 --> Feb 2026
Trial completion date • Trial primary completion date
|
cytarabine • decitabine • cladribine • Depocyte (liposomal cytarabine)
11ms
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) (clinicaltrials.gov)
P2, N=160, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
Trial completion date • Trial primary completion date
|
cytarabine • decitabine • cladribine • Depocyte (liposomal cytarabine)
12ms
Trial completion date • Combination therapy
|
CD33 positive
|
cytarabine • mitoxantrone • Actimab-A (lintuzumab-Ac225) • Depocyte (liposomal cytarabine)
12ms
Trial completion date • Trial initiation date • Trial primary completion date
|
Venclexta (venetoclax) • cytarabine • navitoclax (ABT 263) • mitoxantrone • Neupogen (filgrastim)
12ms
Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS) (clinicaltrials.gov)
P=N/A, N=116, Completed, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Active, not recruiting --> Completed
Trial completion • Real-world evidence • Real-world effectiveness • Real-world
12ms
Triosephosphate isomerase 1 may be a risk predictor in laryngeal squamous cell carcinoma: a multi-centered study integrating bulk RNA, single-cell RNA, and protein immunohistochemistry. (PubMed, Eur J Med Res)
TPI1 is dramatically overexpressed in LSCC than in normal tissue, and the high expression of TPI1 may promote LSCC deterioration through its metabolic and non-metabolic functions. This study contributes to advancing our knowledge of LSCC pathogenesis and may have implications for the development of targeted therapies in the future.
Journal
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ENO1 (Enolase 1)
|
gemcitabine • cladribine
1year
Lintuzumab-Ac225 in Combination With Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
P1, N=26, Active, not recruiting, Medical College of Wisconsin | Trial primary completion date: Oct 2024 --> May 2024
Trial primary completion date • Combination therapy
|
CD33 positive
|
cytarabine • mitoxantrone • Actimab-A (lintuzumab-Ac225) • Depocyte (liposomal cytarabine)
1year
Conditioning Regimen Containing Melphalan and Cladribine for Refractory / Relapsed AML (clinicaltrials.gov)
P2, N=237, Not yet recruiting, Institute of Hematology & Blood Diseases Hospital, China
New P2 trial
|
cytarabine • cyclophosphamide • cladribine • melphalan
1year
Cladribine-Based Chemotherapy for Patients with Secondary Acute Myeloid Leukemia (AML) Arising after Myeloproliferative Neoplasms (MPNs) (ASH 2023)
Cladribine added to a backbone regimen of high dose cytarabine [≥ 1 gram per m2 intravenously (IV) for up to 5 days] and idarubicin (CLIA; further HD-clad) or low dose cytarabine [LDAC; 20 mg twice daily subcutaneously (SQ) for up to 10 days] alternating every two cycles with hypomethylating agent (HMA; regimen referred as LD-clad) have been routinely used in the treatment of AML at our institution. Cladribine added to chemotherapy is an effective approach in patients with AML from MPN, either as an induction therapy for those eligible for SCT or acceptable long-term therapy for non-eligible patients. Noticeably, almost 40% of patients without SCT were alive past 12 months since the initiation of LD-clad therapy. HMA pretreated patients had lower response rates and poor survival even in the frontline setting.
Clinical
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TP53 (Tumor protein P53) • JAK2 (Janus kinase 2) • RUNX1 (RUNX Family Transcription Factor 1) • ASXL1 (ASXL Transcriptional Regulator 1)
|
JAK2 mutation
|
cytarabine • idarubicin hydrochloride • cladribine
1year
Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA) (clinicaltrials.gov)
P=N/A, N=360, Recruiting, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Not yet recruiting --> Recruiting
Enrollment open
1year
Enrollment open • Trial initiation date
1year
The Association between Immune Checkpoint Proteins and Therapy Outcomes in Acute Myeloid Leukaemia Patients. (PubMed, Cancers (Basel))
In summary, we showed the significance of selected ICI as outcome predictors in AML management. Further, multicentre studies are required for validation of those data.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • CD276 (CD276 Molecule) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CD33 (CD33 Molecule) • CD4 (CD4 Molecule)
|
PD-L1 expression • PD-1 expression • CTLA4 expression • PD-1 elevation
|
cytarabine • daunorubicin • cladribine
over1year
Cladribine tablets in people with relapsing multiple sclerosis: A real-world multicentric study from southeast European MS centers. (PubMed, J Neuroimmunol)
Our real-world data on the effectiveness and safety of cladribine tablets are comparable to the pivotal study and other real-world data with no new safety signals.
Journal • Real-world evidence • Real-world