The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML

Acute Myeloid Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03665480
• Other study ID #: G-CSF on MRD in AML
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 4, 2018
• Est. completion date: August 2021

Study information

• Verified date: October 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Qifa Liu
• Phone: 86-20-61641612
• Email: liuqifa628[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Granulocyte-colony stimulating factor (G-CSF) is konwn to have no significant effect on leukemia stem cells and has been widely used in the patients with agranulocytosis after chemotherapy. Minimal residual disease (MRD), an index for early treatment response, plays an important role in prognostic prediction. Numbers of data have shown MRD at day 14 after induction therapy significantly predicts prognosis. However, the retrospetive data from the investigators showed that patients with G-CSF treatment after induction had higher MRD at day 14 but not significantly different at day 28, suggesting that G-CSF might work on the differenciation of hemapoetic stem cells and increase MRD levels at day 14. In this multicenter prospective randomized controlled study, the effect of G-CSF on MRD after induction therapy in newly diagnosed acute myeloid leukemia (AML) is evaluated.

Description:

Granulocyte-colony stimulating factor (G-CSF) is konwn to have no significant effect on leukemia stem cells and has been widely used in the patients with agranulocytosis after chemotherapy. Minimal residual disease (MRD), an good index for early treatment response, plays an important role in prognostic prediction. Numbers of data have shown MRD at day 14 after induction therapy significantly predicts prognosis. However, the retrospetive data from the investigators showed that patients with G-CSF treatment after induction had higher MRD at day 14 but not significantly different at day 28,suggesting that G-CSF might work on the differenciation of hemapoetic stem cells and increase MRD level at day 14. In this multicenter prospective study, the investigators randomizedly divide all participants with newly diagnosed acute myeloid leukemia (AML) into G-CSF treatment group and G-SCF-free group. In G-CSF treatment group, all participants 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 with flow cytometry and quantity PCR if a fusion gene is available in both G-CSF treatment and G-CSF-free groups. Comparision of the difference of MRD levels between the two groups is performed to evaluate the effect of G-CSF on MRD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: August 2021
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

Inclusion Criteria:

Newly diagnosed AML exclusively of APL; 14-65 years old; Neutrophil < 1.5 G/L at the day three after induction.

Exclusion Criteria:

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure); Patients with any conditions not suitable for the trial; NR at day 28 after induction.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Granulocyte Colony-stimulating Factor
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Minimal Residual Disease
• Neoplasm, Residual

Intervention

Drug:
• G-SCF
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.

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Guangzhou First People's Hospital, Peking University Shenzhen Hospital, Second Affiliated Hospital, Sun Yat-Sen University, Shenzhen Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRD1	MRD level is detested by flow cytometry at the day 14 after induction therapy.	Day 14 after induction
Secondary	OS rate	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.	2 years
Secondary	DFS rate	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.	2 years
Secondary	Time for neutropenia	The lasting time for the patients with neutropenia after induction therapy	30 days after induction
Secondary	Infection incidence	The incidence of infection after induction	30 days after induction
Secondary	MRD2	MRD level is detested by flow cytometry at the day 28 after induction therapy.	Day 28 after induction