The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
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|ClinicalTrials.gov Identifier: NCT03665480|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Granulocyte Colony-stimulating Factor Minimal Residual Disease Acute Myeloid Leukemia||Drug: G-SCF||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Granulocyte-colony Stimulating Factor (G-CSF) on Minimal Residual Disease (MRD) After Induction Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)|
|Actual Study Start Date :||September 4, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
Experimental: G-CSF treatment
In G-CSF treatment group, all participants are treated with G-CSF at the dose of 5ug/kg per day until neutrophil higher than 0.5 g/L or 14 days from day three after induction therapy. MRD is monitored at day 14 and 28 with flow cytometry and quantity PCR if a fusion gene is available.
In G-CSF treatment group, all patients are treated with G-CSF at the dose of 5ug/kg pre day until neutrophil higher than 0.5 g/L or 14 days from day three after induction therapy. MRD is monitored at day 14 and 28, respectively, with flow cytometry and quantity PCR if a fusion gene is available.
No Intervention: G-CSF-free
In G-CSF-free group, no participants with newly diagnosed AML are treated with G-CSF after induction therapy.
- MRD1 [ Time Frame: Day 14 after induction ]MRD level is detested by flow cytometry at the day 14 after induction therapy.
- OS rate [ Time Frame: 2 years ]OS is the abbreviation of overall survival. OS rate is caculated as the ratio of survival participants versus total participants during the 2-year follow-up after diagosis.
- DFS rate [ Time Frame: 2 years ]DFS is the abbreviation of disease-free survival. DFS rate is caculated as the ratio of participants with continuous complete remission (CR) versus total participants abtaining CR after induction during the 2-year follow-up after diagosis.
- Time for neutropenia [ Time Frame: 30 days after induction ]The lasting time for the patients with neutropenia after induction therapy
- Infection incidence [ Time Frame: 30 days after induction ]The incidence of infection after induction
- MRD2 [ Time Frame: Day 28 after induction ]MRD level is detested by flow cytometry at the day 28 after induction therapy.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665480
|Contact: Qifa Liuemail@example.com|
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China|
|Contact: Qifa Liu firstname.lastname@example.org|
|Principal Investigator:||Qifa Liu||Nanfang Hospital of Southern Medical University|