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

NCT03665480 | Unknown Phase 2 DMC

• 1 other identifier: G-CSF on MRD in AML
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• MRD1

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

  Day 14 after induction

Secondary Outcomes (5)

• OS rate

  2 years

• DFS rate

  2 years

• Time for neutropenia

  30 days after induction

• Infection incidence

  30 days after induction

• MRD2

  Day 28 after induction

Study Arms (2)

G-CSF treatment

EXPERIMENTAL

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

G-CSF-free

NO INTERVENTION

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

Interventions

G-SCF DRUG

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.

G-CSF treatment

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed AML exclusively of APL; 14-65 years old; Neutrophil \< 1.5 G/L at the day three after induction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Second Affiliated Hospital, Sun Yat-Sen University: collaborator
• Guangzhou First People's Hospital: collaborator
• Shenzhen Hospital of Southern Medical University: collaborator
• Peking University Shenzhen Hospital: collaborator

Study Sites (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Neoplasm, Residual; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Qifa Liu

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qifa Liu

CONTACT

86-20-61641612; liuqifa628@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: September 11, 2018
• Study Start: September 4, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

CN (1)