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

Primary Purpose

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

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
G-SCF
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Granulocyte Colony-stimulating Factor

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Hematology,Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

G-CSF treatment

G-CSF-free

Arm Description

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-free group, no participants with newly diagnosed AML are treated with G-CSF after induction therapy.

Outcomes

Primary Outcome Measures

MRD1
MRD level is detested by flow cytometry at the day 14 after induction therapy.

Secondary Outcome Measures

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

Full Information

First Posted
August 7, 2018
Last Updated
October 5, 2018
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Second Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, Shenzhen Hospital of Southern Medical University, Peking University Shenzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03665480
Brief Title
The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Second Affiliated Hospital, Sun Yat-Sen University, Guangzhou First People's Hospital, Shenzhen Hospital of Southern Medical University, Peking University Shenzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Granulocyte Colony-stimulating Factor, Minimal Residual Disease, Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
G-CSF treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
G-CSF-free
Arm Type
No Intervention
Arm Description
In G-CSF-free group, no participants with newly diagnosed AML are treated with G-CSF after induction therapy.
Intervention Type
Drug
Intervention Name(s)
G-SCF
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRD1
Description
MRD level is detested by flow cytometry at the day 14 after induction therapy.
Time Frame
Day 14 after induction
Secondary Outcome Measure Information:
Title
OS rate
Description
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.
Time Frame
2 years
Title
DFS rate
Description
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 Frame
2 years
Title
Time for neutropenia
Description
The lasting time for the patients with neutropenia after induction therapy
Time Frame
30 days after induction
Title
Infection incidence
Description
The incidence of infection after induction
Time Frame
30 days after induction
Title
MRD2
Description
MRD level is detested by flow cytometry at the day 28 after induction therapy.
Time Frame
Day 28 after induction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qifa Liu
Phone
86-20-61641612
Email
liuqifa628@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Email
liuqifa628@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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