Phase cladribine. Medical search. Frequent questions

The brain atrophy analysis evaluated the effect of Cladribine tablets on brain volume loss (BVL) over 2 years in RMS and the association of BVL with confirmed disability progression in 1,025 (77.3%) of the patients in CLARITY. (disabled-world.com)

A Phase II Study of Cladribine and Low Dose Cytarabine in Combination With Venetoclax, Alternating With Aza. (sparkcures.com)
This Phase Ib/II clinical trial evaluates safety, tolerability, and preliminary efficacy of uproleselan added to cladribine and low-dose cytarabine (LDAC) in patients with treated secondary AML. (wapakdailynews.com)

Additionally, at ACTRIMS, data will be presented that includes analyses of the CLARIFY-MS study, showing the potential of MAVENCLAD® (cladribine tablets) to improve outcomes in an impactful way for people living with RMS. (koreanewswire.co.kr)
Our current MS portfolio includes two approved products for the treatment of relapsing MS (RMS) - Rebif ® (interferon beta-1a) and Mavenclad ® (cladribine tablets). (emdgroup.com)

Phase III CLARITY study data revealed significant reduction in brain atrophy in patients on short course of investigational Cladribine Tablets over two years. (disabled-world.com)
These findings reinforce and expand on the consistent and positive effect of Cladribine Tablets in improving clinically relevant outcomes, such as reducing relapse rate and disability. (disabled-world.com)
Post hoc analysis of Phase III CLARITY study data recently published in Multiple Sclerosis Journal showed statistically significant reduction in brain atrophy in patients on a short course of investigational Cladribine Tablets over two years compared with patients receiving placebo. (disabled-world.com)
The post hoc analysis showed that Cladribine Tablets reduced the annualised rate of brain volume loss - also known as brain atrophy - compared with placebo in patients with relapsing remitting multiple sclerosis (RRMS). (disabled-world.com)
The CLARITY study was a two-year (96-week), randomised, double-blind, placebo-controlled Phase III study of Cladribine Tablets in 1,326 people with RRMS. (disabled-world.com)
The mean percentage brain volume loss per year was significantly reduced in patients treated with Cladribine Tablets 3.5 mg/kg (--0.56%±0.68, p=0.010, n=336) and 5.25 mg/kg (--0.57%±0.72, p=0.019, n=351) compared with patients treated with placebo (--0.70%±0.79, n=338). (disabled-world.com)
These findings reinforce and expand on the consistent and positive effect of Cladribine Tablets in improving clinically relevant outcomes, such as reducing relapse rate and disability, and further our resolve to make this investigational therapy available for patients living with RRMS," said Steven Hildemann, MD, PhD, Global Chief Medical Officer and Head of Global Medical Affairs and Safety, Merck KGaA, Darmstadt, Germany. (disabled-world.com)
1 NHS England and Merck, the manufacturer of cladribine tablets, have partnered on the commercial access agreement, representing an example of a "win-win-win" for the NHS, patients and industry at a time of intense financial pressure on the NHS. (acnr.co.uk)
3 Last week, NICE issued a Final Appraisal Determination (FAD) that recommends cladribine tablets as an option for treating highly active MS in adults. (acnr.co.uk)
Use of cladribine tablets is recommended only if a person has rapidly evolving severe relapsing-remitting multiple sclerosis, that is, at least two relapses in the previous year and at least one T1 gadolinium-enhancing lesion at baseline MRI or relapsing-remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as one relapse in the previous year and MRI evidence of disease activity. (acnr.co.uk)
In the FAD, NICE concluded that cladribine tablets are less costly than other treatments and require less frequent dosing and monitoring requirements. (acnr.co.uk)
Cladribine tablets are taken for a maximum of 10 days in the first year and a maximum of 10 days in the second year, with no additional treatment needed in years three and four. (acnr.co.uk)
Patients can take cladribine tablets at home from the first dose as treatment does not require hospital administration. (acnr.co.uk)
4 Monitoring is limited to the first two years only, meaning that cladribine tablets have the lowest administration and monitoring burden of all available high efficacy disease modifying therapies. (acnr.co.uk)
Cladribine tablets received marketing authorisation from the European Commission in August 2017 based on an extensive 12-year clinical trial programme. (acnr.co.uk)
Cladribine tablets should not be taken by certain people, including immunocompromised patients and pregnant women. (acnr.co.uk)
The current study analyzed the effect of cladribine tablets in subgroups of participants in the ORACLE-MS study by baseline demographics and disease characteristics. (providence.org)
cladribine tablets 5.25 mg/kg, n=204). (providence.org)
This analysis focused primarily on the results for the cladribine tablets 3.5 mg/kg group because this dosage is approved for relapsing forms of MS. (providence.org)
CONCLUSION: In this post hoc analysis of the ORACLE-MS study, cladribine tablets reduced the risk of conversion to multiple sclerosis and lesion burden in participants with an FCDE in the overall ITT population and multiple subgroups defined by baseline demographics and lesion characteristics. (providence.org)

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operating as EMD Serono in Canada, today announced the publication of the results of a post hoc analysis of the Phase III CLARITY study in Multiple Sclerosis Journal . (disabled-world.com)
The MASTER-2 trial is an observational study to evaluate the effectiveness and patient-reported outcomes in people with relapsing forms of multiple sclerosis who are transitioning from ocrelizumab to cladribine. (massgeneral.org)
Cladribine is used for the treatment of hairy cell leukemia and multiple sclerosis (MS). As a purine analog, it is a synthetic anti-cancer agent that also suppresses the immune system. (ncats.io)
Oral formulations of cladribine used in multiple sclerosis are classified in this group, while parenteral formulations for cancer are classified in L01BB. (whocc.no)
GENEVA, Switzerland, December 12 (HSMN NewsFeed) -- Serono (virt-x: SEO and NYSE: SRA) announced today the initiation of a Phase III clinical trial to evaluate the effect of two dosage regimens of the new formulation of Rebif (interferon beta-1a 44 mcg, three times a week or once a week) on the time to conversion to multiple sclerosis (MS) in people with first clinical symptoms suggestive of the disease. (salesandmarketingnetwork.com)
A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). (clinicaltrialsregister.eu)

A low level of T cells, which is commonly seen after treatment with cladribine or pentostatin, and the consequent reduction of these cytokines, is also associated with reduced levels of hairy cells. (wikipedia.org)
Chemotherapy drugs, specifically purine analogs such as cladribine and pentostatin, are considered an initial treatment option for most individuals with hairy cell leukemia. (mordorintelligence.com)
Randomized Phase II Trial of Rituximab with Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia (NCI-10-C-0025). (cancer.gov)
Pentostatin , another chemotherapy drug in the same class as cladribine, is also effective against this cancer. (cancer.gov)
However, most patients and doctors prefer cladribine because the typical course of treatment lasts 5-7 days as opposed to 3-6 months or longer with pentostatin. (cancer.gov)
Cladribine and pentostatin have different mechanisms of action, but they both produce high rates of complete remission and have similar toxicity. (cancer.gov)
Although responses to cladribine and pentostatin can last years or even decades, these drugs do not appear to cure most patients. (cancer.gov)
Although the hairy cells that remain after cladribine or pentostatin treatment are essentially always CD20 positive, only a minority of patients respond to rituximab therapy alone. (cancer.gov)
However, combinations of rituximab and either cladribine or pentostatin seem to be highly effective in nearly all patients. (cancer.gov)
Dr. Kreitman is currently directing a randomized clinical trial of rituximab with cladribine in newly diagnosed (untreated) patients and patients who have had only one prior course of cladribine, but no prospective trial has yet evaluated rituximab with pentostatin in patients with hairy cell leukemia. (cancer.gov)
Bendamustine's mechanism of action is different from those of cladribine and pentostatin, and it is known to act synergistically with rituximab in lymphoma cells. (cancer.gov)
The majority of these patients will have received only cladribine, but because pentostatin works differently, some patients with disease that is refractory to cladribine may be sensitive to pentostatin. (cancer.gov)

A board to discuss future MS therapies in early stage (Phase I or II) trials. (thisisms.com)

Based on our results showing EPOCH to be effective and well tolerated, we began a phase II study of EPOCH in previously untreated patients with aggressive lymphomas. (cancer.gov)
This is a multicenter, open-label, Phase 1/2a dose escalation and expansion study of orally administered emavusertib (CA-4948) monotherapy in adult patients with Acute Myelogenous Leukemia (AML) or high risk Myelodysplastic Syndrome (MDS). (rochester.edu)
The DDDs for alemtuzumab and cladribine are based on the average calculated daily dose in the first two years (year 1 and 2) when all patients receive medication. (whocc.no)
Phase I clinical and pharmacological study of O6-benzylguanine followed by carmustine in patients with advanced cancer. (uchicago.edu)
First-in-human, phase I study of elisidepsin (PM02734) administered as a 30-min or as a 3-hour intravenous infusion every three weeks in patients with advanced solid tumors. (uchicago.edu)
Phase I clinical and pharmacological study of iododeoxyuridine and bleomycin in patients with advanced cancer. (uchicago.edu)
Phase I clinical and pharmacological study of thymidine (NSC 21548) and cis-diamminedichloroplatinum(II) in patients with advanced cancer. (uchicago.edu)
A phase I study of antisense oligonucleotide GTI-2040 given by continuous intravenous infusion in patients with advanced solid tumors. (uchicago.edu)
A phase I study of cantuzumab mertansine administered as a single intravenous infusion once weekly in patients with advanced solid tumors. (uchicago.edu)
Phase I and pharmacokinetic study of 24-hour infusion 5-fluorouracil and leucovorin in patients with organ dysfunction. (uchicago.edu)
Phase I study to evaluate multiple regimens of intravenous 5-fluorouracil administered in combination with weekly gemcitabine in patients with advanced solid tumors: a potential broadly active regimen for advanced solid tumor malignancies. (uchicago.edu)
Phase I clinical and pharmacogenetic study of weekly TAS-103 in patients with advanced cancer. (uchicago.edu)
Phase I and pharmacologic study of continuous infusion topotecan in combination with cisplatin in patients with advanced cancer: a Cancer and LeukemiaGroup B study. (uchicago.edu)
In Phase III data presented in August, Boehringer Ingelheim showed that a higher and a lower dose of dabigatran (Pradaxa) , which inhibits thrombin directly, were superior to warfarin for patients with atrial defibrillation, a heart arrhythmia frequently associated with strokes. (pharmexec.com)
A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients Wi. (sparkcures.com)
A Phase I/II Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or Hig. (sparkcures.com)
A Phase Ib/II Study of APG-2575 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia (AM. (sparkcures.com)
Preliminary results from 12 evaluable patients at 3.3 months follow-up found cladribine and LDAC combined with uproleselan generated few treatment-related adverse events. (wapakdailynews.com)
This Phase I study is evaluating the safety, tolerability, and preliminary efficacy of uproleselan in combination with azacitidine (Aza) and Venetoclax (Ven) in patients with untreated AML who were unfit for intensive chemotherapy. (wapakdailynews.com)
Uproleselan (yoo' pro le'se lan), currently in a comprehensive Phase 3 development program in acute myeloid leukemia (AML), received Breakthrough Therapy designation from the U.S. FDA and from the Chinese National Medical Products Administration for treatment of adult AML patients with relapsed or refractory disease. (wapakdailynews.com)
The U.S. FDA has placed a partial clinical hold on the phase Ib KOMET-001 study of Menin-KMT2A inhibitor KO-539 for the treatment of patients with relapsed or refractory AML. (devbrandcast.com)
Phase I/II Study of Azacitidine (AZA) with Venetoclax (VEN) and Magrolimab (Magro) in Patients (pts) with Newly Diagnosed Older/Unfit or High-Risk Acute Myeloid Leukemia (AML) and Relapsed/Refractory (R/R) AML. (devbrandcast.com)
Efficacy and Safety of Sabatolimab (MBG453) in Combination with Hypomethylating Agents (HMAs) in Patients (Pts) with Very High/High-Risk Myelodysplastic Syndrome (vHR/HR-MDS) and Acute Myeloid Leukemia (AML): Final Analysis from a Phase Ib Study. (devbrandcast.com)

Phase 2 Clinical Trial Evaluating the Safety, Tolerability, and Effectiveness of Venetoclax combined with Carfilzomib and Dexamethasone in Relapsed/Refractor. (sparkcures.com)
A Phase Ib /II Open-label, Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of APG-2575. (sparkcures.com)

Phase 3 Clinical Trial comparing the use of venetoclax combined with dexamethasone versus Pomalidomide combined with dexamethasone in Relapsed/Refractory Mul. (sparkcures.com)
A Phase I/II Study of Venetoclax in Combination With Azacitidine in Relapsed/Refractory High-Risk Myelodysp. (sparkcures.com)

An Open-Label Phase 1a/1b Dose Escalation and Expansion Cohort Study of SL-172154 (SIRPα-Fc-CD40L) in Combi. (sparkcures.com)

LEUSTATIN (cladribine) Injection should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. (nih.gov)
LEUSTATIN (cladribine) Injection (also commonly known as 2-chloro-2΄-deoxy- β -D-adenosine) is a synthetic antineoplastic agent for continuous intravenous infusion. (nih.gov)
LEUSTATIN Injection is available in single-use vials containing 10 mg (1 mg/mL) of cladribine, a chlorinated purine nucleoside analog. (nih.gov)

In addition, we have our investigational MS treatment evobrutinib, which is the first Bruton´s tyrosine kinase (BTK) inhibitor to complete Phase III trial enrollment. (emdgroup.com)

Cladribine injection is a potent antineoplastic agent with potentially significant toxic side effects. (ncats.io)
A Phase 1, Open-Label, Multicenter, Dose Escalation Study of PRT1419 Injection as Monotherapy or in Combina. (sparkcures.com)

however, severe neurological toxicity has been reported rarely following treatment with standard cladribine dosing regimens. (nih.gov)

A Phase I Study of Venetoclax in Combination With Cytotoxic Chemotherapy, Including Calaspargase Pegol, for. (sparkcures.com)
Hairy cell leukemia is usually treated with a chemotherapy drug called cladribine when signs or symptoms of the disease develop, such as low blood cell counts, recurrent infections, or a swollen spleen. (cancer.gov)
Chemotherapy for AML is broken down into three phases: induction phase, consolidation (or intensification), and maintenance phase. (oncolink.org)

Data from the ongoing Phase II open-label extension (OLE) trial of evobrutinib showed that treatment benefits were maintained over four years, with no new safety signals. (koreanewswire.co.kr)
A Phase I/II Study of Quizartinib in Combination With Decitabine and Venetoclax for the Treatment of Patien. (sparkcures.com)
A Phase I/II Study of Venetoclax in Combination With ASTX727 (Cedazuridine/Decitabine) in Treatment-Naïve H. (sparkcures.com)
In December we announced a strategically focused expansion of our neuroinflammatory pipeline with the acquisition of the rights to develop cladribine for the treatment of generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). (emdgroup.com)
after a remission, you will enter this second phase of treatment. (oncolink.org)

Cladribine plasma concentration after intravenous administration declines multi-exponentially with an average half-life of 6.7 +/- 2.5 hours. (nih.gov)

The first study of rituximab in MS was a Phase 1 clinical trial that enrolled 26 people with relapsing-remitting MS (RRMS). (multiplesclerosisnewstoday.com)

A phase I trial of escalating doses of trastuzumab combined with daily subcutaneous interleukin 2: report of cancer and leukemia group B 9661. (uchicago.edu)
A Single-arm, Multi-center Phase II Trial of Bendamustine/Rituximab Induction Followed by Venetoclax and Ri. (sparkcures.com)
In an analysis of the phase III RATIFY trial published in Leukemia , researchers examined the molecular landscape of FLT3 internal tandem duplication (ITD) mutations in AML, confirming this subtype's distinct heterogeneity and the negative prognostic impact of the tyrosine kinase domain-1 (TKD1) insertion site. (devbrandcast.com)

A phase I study of the oral combination of CI-994, a putative histone deacetylase inhibitor, and capecitabine. (uchicago.edu)

A Phase 1 Study of Triplet Therapy With Navitoclax, Venetoclax, and Decitabine for High-risk Myeloid Malign. (sparkcures.com)

The DDD for eculizumab is based on the dose given in the maintenance phase. (whocc.no)

It is the first BTK inhibitor to demonstrate clinical efficacy in the largest Phase II study with follow-up beyond three years as well as demonstrate an impact on early biomarkers of ongoing central inflammation that correlate with disease progression, including slowly expanding lesions (SEL) volume and levels of blood neurofilament light chain protein (NfL). (koreanewswire.co.kr)

A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/C. (sparkcures.com)

These data further support the twice-daily dosing currently being examined in Phase III clinical trials. (koreanewswire.co.kr)
We look forward to presenting detailed results from our fully enrolled Phase III clinical trials in the near future. (koreanewswire.co.kr)
Learn more about clinical trials basics and early-phase clinical trials , as well as some of the unique features our research program, including our Translational Research Unit . (froedtert.com)
Another member of the class, rivaroxaban (Xarelto), has been launched for the prevention of post-surgical thromboembolism in Canada and Britain, but as with apixaban, the high stakes are riding on Phase III trials in acute coronary syndrome. (pharmexec.com)

A Phase 1 Study of Adding Venetoclax to a Reduced Intensity Conditioning Regimen and to Maintenance in Comb. (sparkcures.com)
A Phase Ib/II Study Evaluating Navitoclax After Failure of Hypomethylating Agent and Venetoclax for Treatme. (sparkcures.com)
A Phase II Study of Venetoclax in Combination With 10-Day Decitabine in Newly Diagnosed Elderly or Relapsed. (sparkcures.com)

Results of Polish medical centres within an international randomized phase III study of docetaksel plus cisplatin and docetaksel plus carboplatin versus winorelbine plus cisplatin for advanced non-small-cell lung cancer. (edu.pl)

As cladribine can cross the blood brain barrier and can kill dividing and non-dividing T and B cells and can apparently kill plasma cells. (ncats.io)
In this study, we investigated the Ag-NOR of acute leukemic cells and its relation to the in vivo proportion of bone marrow leukemic cells in DNA synthetic phase. (karger.com)

A Phase I Study Investigating the Safety & Efficacy of Danvatirsen as Monotherapy Followed by Combination W. (sparkcures.com)

Diseases14

Chemicals and Drugs19

Analytical, Diagnostic and Therapeutic Techniques and Equipment19

Phenomena and Processes5

Information Science1

Health Care8

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Evaluated the effect of Cladribine tablets1

Cytarabine2

MAVENCLAD2

Tablets20

Multiple Sclerosis6

Pentostatin12

Therapies1

Patients23

Tolerability2

Refractory2

Cohort study1

LEUSTATIN3

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Treatment5

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Venetoclax3

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