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NCT03913312

Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML

Status unknown Phase 1, PHASE2 Last updated 23 July 2019
What this trial tests

Phase 1, PHASE2 trial testing Unrelated cord blood in Acute Myeloid Leukemia in 150 participants. Status unknown.

Timeline
1 September 2018
Primary endpoint
31 December 2019
30 September 2022

Quick facts

Lead sponsorRuijin Hospital
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment150
Start date1 September 2018
Primary completion31 December 2019
Estimated completion30 September 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Ruijin Hospital

Who can join

Adults 60 to 75, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute myeloid leukemia (AML) is a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (\>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. Based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with AML who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. By assessing the patient's DFS,OS,RFS and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Acute Myeloid Leukemia

Currently open trials in the same condition.

Other Ruijin Hospital trials

Trials by the same sponsor.

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Data sources for this page

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