A Phase 2 interventional study of Decitabine and Ara-C and Ara-C in Leukemia, Myeloid, sponsored by Xuejie Jiang. Status unknown at 1 site in China. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Xuejie Jiang · Phase 2, Interventional, and Treatment
It is often impossible to find therapeutic target in intermediate-risk AML, so it is very important to select appropriate chemotherapy protocol to eliminate minimal residual disease (MRD) in these AML patients. Recent studies demonstrated that leukemia microenvironment is the shelter nich for leukemia stem cells and the essential reason for impossibly eliminating MRD. Demethylation drug not only prove the effect of chemotherapy, but also change leukemia microenvironment through epigenetics modification. Both of them will result in eliminating MRD in patients with AML. The investigators designed a multicenter randomized control clinical trail to evaluate the effect of demethylation drug combined with chemotherapy in AML patients with intermediate-risk factors after hematological complete remission. Efficacy will be evaluated through MRD detected by flow cytometry every 1 month. Continuous negative MRD indicates a good prognosis. The patients with continuous negative MRD can select auto-HSCT or consolidation chemotherapy, those with continuous positive MRD should be considered as candidates of allo-HSCT. Overall survival and relapse free survival will be recorded after follow-up every 3 months. It will provide a basis for precision therapy and a new way for designing a novel protocol for intermediate-risk AML. This clinical trail will benefit to the AML patients with intermediate-risk factors.
136 studies on the registry are indexed under Leukemia, Myeloid; 23 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 117 interventional studies indexed under Leukemia, Myeloid.
Browse Leukemia, Myeloid studies →This is the only study on the registry with Xuejie Jiang as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive decitabine (15mg/m2 d1-5) combined with high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.
Drug: Decitabine and Ara-C
Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.
Drug: Ara-C
Drug pages: Decitabine · Cytarabine
Decitabine in combination with high-dose of Ara-C is used to improve the effect of consolidation chemotherapy. It is expected to make minimal residual disease (MRD) become negative in more patients with intermediate-risk AML.
Also known as: Decitabine in combination with high-dose of Ara-C
Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.
Also known as: High-dose of Ara-C
Minimal residual disease
Minimal residual disease is detected by flow cytometry every 1 month in AML patients.
Time frame: 1 month
Overall survival
AML patients are followed up every 3 months to evaluate overall survival
Time frame: 3 months
Relapse free survival
AML patients are followed up every 3 months to evaluate relapse free survival.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Jan 2022, 47 months after the start.
Of 18 phase 2 interventional studies under Leukemia, Myeloid, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 72. This study's planned 47 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Decitabine · Cytarabine