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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

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.

Condition or disease Intervention/treatment Phase
Granulocyte Colony-stimulating Factor Minimal Residual Disease Acute Myeloid Leukemia Drug: G-SCF Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
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


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.



Primary Outcome Measures :
  1. MRD1 [ Time Frame: Day 14 after induction ]
    MRD level is detested by flow cytometry at the day 14 after induction therapy.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Time for neutropenia [ Time Frame: 30 days after induction ]
    The lasting time for the patients with neutropenia after induction therapy

  4. Infection incidence [ Time Frame: 30 days after induction ]
    The incidence of infection after induction

  5. MRD2 [ Time Frame: Day 28 after induction ]
    MRD level is detested by flow cytometry at the day 28 after induction therapy.



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Contacts
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Contact: Qifa Liu 86-20-61641612 liuqifa628@163.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China
Contact: Qifa Liu       liuqifa628@163.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Second Affiliated Hospital, Sun Yat-Sen University
Guangzhou First People's Hospital
Shenzhen Hospital of Southern Medical University
Peking University Shenzhen Hospital
Investigators
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Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University

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Responsible Party: Qifa Liu, professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03665480     History of Changes
Other Study ID Numbers: G-CSF on MRD in AML
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs