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

NCT03665480 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2018-10-09

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Second Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Guangzhou First People's Hospital

    collaborator OTHER

  • Shenzhen Hospital of Southern Medical University

    collaborator OTHER

  • Peking University Shenzhen Hospital

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Qifa Liu · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2020-08-31
Completion
2021-08-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03665480 on ClinicalTrials.gov