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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665480
|Contact: Qifa Liufirstname.lastname@example.org|
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China|
|Contact: Qifa Liu email@example.com|
|Principal Investigator:||Qifa Liu||Nanfang Hospital of Southern Medical University|