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Decitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality risk


- candidate number23607
- NTR NumberNTR5644
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jan-2016
- Secondary IDs2015-02 LUMC METC 
- Public TitleDecitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality risk
- Scientific TitleDecitabine-cytarabine chemotherapy in elderly AML and high risk MDS patients (> 65 years) with high early mortality risk
- ACRONYMDecitabine-cytarabine
- hypothesisIn this study we explore the feasibility of combined decitabine and cytarabine chemotherapy in AML and high risk MDS patients with a high risk of early mortality (day 30 mortality) during standard induction chemotherapy (HCT-CI co-morbidity index >=2). With the decitabine-cytarabine chemotherapy we hope to achieve a low incidence of early mortality. At the same time we hope to achieve complete remissions in the majority of patients.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML), Chemotherapy
- Inclusion criteria1. Patients with AML or high risk MDS (IPSS-R 4.5)
2. > 65 years
3. WHO performance score 0-2
4. HCT-CI score >=2
5. Written informed consent
- Exclusion criteria1. Previous treatment with decitabine, azacitidine or intensive chemotherapy for this MDS/AML (treatment with chemotherapy for previous other diseases is acceptable)
2. Acute promyelocytic leukemia
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2016
- planned closingdate1-mrt-2019
- Target number of participants20
- InterventionsPatients will receive decitabine one time daily 20 mg/m2 during 5 days, directly followed by cytarabine 100 mg/m2 per day as continuous infusion during 5 days. At day 28-35 after the start of chemotherapy, remission status will be determined. In case of CR, CRi or morphologic leukemia-free state, patients will receive a second cycle of decitabine-cytarabine.
- Primary outcomeMortality at day 30 after start of decitabine-cytarabine chemotherapy
- Secondary outcomeRemission status after one and two cycles of decitabine-cytarabine
- Timepoints1. Day 30 after start of decitabine-cytarabine chemotherapy
2. Four weeks after discharge from the second cycle of decitabine-cytarabine (end of study)
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. P.A. Borne, von dem
- CONTACT for SCIENTIFIC QUERIESDr. P.A. Borne, von dem
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- Publications
- Brief summaryThis is a phase 1-2 study to determine feasiblity and safety of decitabine-cytarabine chemotherapy in patients > 65 years with AML or high risk MDS, who have a high risk for day 30 mortality during standard treatment with intensive chemotherapy bcause of the presence of co-morbidity (HCT-CI >=2).
- Main changes (audit trail)
- RECORD13-jan-2016 - 28-feb-2016


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