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

The Effect of Granulocyte-colony Stimulating Factor (G-CSF) on Minimal Residual Disease (MRD) After Induction Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)

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.

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia; Minimal Residual Disease; Granulocyte Colony-stimulating Factor
• Intervention / Treatment: Drug: G-SCF

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 122
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Qifa Liu; Phone Number: 86-20-61641612; Email: liuqifa628@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Department of Hematology,Nanfang Hospital, Southern Medical University
      • Contact: Qifa Liu; Email: liuqifa628@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
No Intervention: G-CSF-free; In G-CSF-free group, no participants with newly diagnosed AML are treated with G-CSF after induction therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRD1	MRD level is detested by flow cytometry at the day 14 after induction therapy.	Day 14 after induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time for neutropenia	The lasting time for the patients with neutropenia after induction therapy	30 days after induction
Infection incidence	The incidence of infection after induction	30 days after induction
MRD2	MRD level is detested by flow cytometry at the day 28 after induction therapy.	Day 28 after induction

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Guangzhou First People's Hospital; Second Affiliated Hospital, Sun Yat-Sen University; Peking University Shenzhen Hospital; Shenzhen Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 5, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Neoplasm, Residual
• Other Study ID Numbers: G-CSF on MRD in AML

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No