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Dacogen (Decitabine) - Summary

 
 



DACOGEN SUMMARY

Dacogen (decitabine) for Injection contains decitabine (5-aza-2'-deoxycitidine), an analogue of the natural nucleoside 2'-deoxycytidine.

Dacogen is indicated for treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.


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NEWS HIGHLIGHTS

Published Studies Related to Dacogen (Decitabine)

Low-dose decitabine-based chemoimmunotherapy for patients with refractory advanced solid tumors: a phase I/II report. [2014]
Aberrant DNA methylation is one of the main drivers of tumor initiation and progression... The low-dose DAC decitabine-based chemoimmunotherapy might be a promising protocol for improving the specificity and efficiency of patients with refractory advanced solid tumors.

A randomised, phase II trial of the DNA-hypomethylating agent 5-aza-2'-deoxycytidine (decitabine) in combination with carboplatin vs carboplatin alone in patients with recurrent, partially platinum-sensitive ovarian cancer. [2014]
resistance to carboplatin in women with relapsed ovarian cancer... CONCLUSIONS: With this schedule, the addition of decitabine appears to reduce

Decitabine can be safely reduced after achievement of best objective response in patients with myelodysplastic syndrome. [2013]
CONCLUSION: DD/DR may be safely accomplished once the patient has achieved best

Randomized open-label phase II study of decitabine in patients with low- or intermediate-risk myelodysplastic syndromes. [2013]
with low- or intermediate-1-risk myelodysplastic syndrome (MDS)... CONCLUSION: In this phase II study, low-dose decitabine showed promising results

Induction of hypomethylation and molecular response after decitabine therapy in patients with chronic myelomonocytic leukemia. [2008]
Decitabine's mechanism of action in chronic myelomonocytic leukemia remains incompletely understood. We studied the dynamics of neoplastic cell clearance during decitabine treatment (100 mg/m(2) per course every 4 weeks) using quantitative monitoring of mutant alleles by pyrosequencing...

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Clinical Trials Related to Dacogen (Decitabine)

Phase I/II - Dasatinib and Decitabine [Recruiting]
The goal of this clinical research study is to learn if combining Sprycel (dasatinib) and Dacogen (decitabine) can help to control CML. The dose level of decitabine will also be studied. Dasatinib is designed to block the protein that is responsible for chronic myeloid leukemia. Decitabine is designed to affect the mechanism that cells use to control the expression of certain genes, some of which are important in the progression of CML.

An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) Alone in Participants With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy [Recruiting]
The primary objective of study Part A is to assess the safety of JNJ-56022473 (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B is to assess the event-free survival (EFS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive DACOGEN (decitabine) plus JNJ-56022473 at the RP2D or DACOGEN (decitabine alone).

Therapeutic Effect and Safety Study of Decitabine in Elderly Acute Myeloid Leukemia Patients [Active, not recruiting]

Omacetaxine and Decitabine in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS) [Recruiting]
This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.

Dose Finding Study of Post-BMT Decitabine Maintenance Treatment in Higher-risk MDS and MDS/AML [Recruiting]
Brief Scientific Rationale: Decitabine has been shown to be effective for treatment of MDS and associated with very limited extramedullary toxicity at the lower doses. Furthermore, the hypomethylating effects of decitabine require an extended period of therapy and are likely to be more beneficial in the setting of a minimal residual disease after transplantation. The drug might exert a cytoreductive effect on the MDS clone, but ex vivo expansion strategy using decitabine and HDAC inhibitor provides a potential to expand the number of hematopoietic stem cells. There are lots of evidence which showed the the drug have immunostimulatory effects and can be used to enhance graft-versus leukemia effects. And also, some investigator suggested that decitabine could induce FOXP3 expression, promoting the conversion of naïve T cells to Tregs which are known to suppress GVHD while maintaining GVL effect in allo-SCT setting. As such, decitabine is an ideal agent to be investigated in the post-transplant setting. The investigators hypothesized that post-transplant maintenance therapy with decitabine may reduce relapse rate, which may maximize the beneficial effects from reduced TRM of ATG-containing FB4 or FB2 conditioning regimen in higher-risk MDS or AML evolving from MDS patients.

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Reports of Suspected Dacogen (Decitabine) Side Effects

Toxicity TO Various Agents (10)Colitis (7)Pyrexia (6)Febrile Neutropenia (5)Oedema Peripheral (4)Hypotension (4)Mucosal Inflammation (4)Cardiac Failure (4)Productive Cough (3)Lung Infection (3)more >>


Page last updated: 2015-08-10

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