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

Last updated: October 5, 2018
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting

Phase

2/3

Condition

Leukemia

Platelet Disorders

Acute Myeloid Leukemia

Treatment

N/A

Clinical Study ID

NCT03665480
G-CSF on MRD in AML
  • Ages 14-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Newly diagnosed AML exclusively of APL; 14-65 years old; Neutrophil < 1.5 G/L at the daythree after induction.

Exclusion

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 Design

Total Participants: 122
Study Start date:
September 04, 2018
Estimated Completion Date:
August 31, 2021

Study 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.

Connect with a study center

  • Department of Hematology,Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

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