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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
Sponsor:
Collaborators:
Second Affiliated Hospital, Sun Yat-Sen University
Guangzhou First People's Hospital
Shenzhen Hospital of Southern Medical University
Peking University Shenzhen Hospital
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE August 7, 2018
First Posted Date  ICMJE September 11, 2018
Last Update Posted Date October 9, 2018
Actual Study Start Date  ICMJE September 4, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
MRD1 [ Time Frame: Day 14 after induction ]
MRD level is detested by flow cytometry at the day 14 after induction therapy.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03665480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of G-CSF on MRD After Induction Therapy in Newly Diagnosed AML
Official Title  ICMJE The Effect of Granulocyte-colony Stimulating Factor (G-CSF) on Minimal Residual Disease (MRD) After Induction Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Granulocyte Colony-stimulating Factor
  • Minimal Residual Disease
  • Acute Myeloid Leukemia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: G-SCF
  • No Intervention: G-CSF-free
    In G-CSF-free group, no participants with newly diagnosed AML are treated with G-CSF after induction therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2018)
122
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qifa Liu 86-20-61641612 liuqifa628@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03665480
Other Study ID Numbers  ICMJE G-CSF on MRD in AML
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qifa Liu, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE
  • Second Affiliated Hospital, Sun Yat-Sen University
  • Guangzhou First People's Hospital
  • Shenzhen Hospital of Southern Medical University
  • Peking University Shenzhen Hospital
Investigators  ICMJE
Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP