Phase III rhu_GM-CSF + 3 Induction Regimens in Adults With Acute Non-Lymphocytic Leukemia

Phase 3

Completed

• Conditions: Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia
• Interventions: Drug: Placebo; Drug: GM-CSF priming

• Registration Number: NCT04446052
• Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary

Phase III Study of Priming with Granulocyte-Macrophage Colony Stimulating Factor (rhu-GM-CSF) and ofThree Induction Regimens in Adult Patients (Over 55) with Acute Non-Lymphocytic Leukemia

Detailed Description

Not available

Study Timeline

• Study Start: 1993-05-21
• Primary Completion: 2002-07-10
• Study Completion: 2002-07-10
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-24
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

• All patients with acute non-lymphocytic leukemia are eligible for the study.

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
GM-CSF priming	GM-CSF priming	-

Primary Outcome Measures

Name	Time	Method
complete remission rates	3 years