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

Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia Clinical Trial

Official title:

Phase III Study Priming With rhu_GM-CSF and of Three Induction Regimens in Adult Patients (55 and Over) With Acute Non-Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446052
• Other study ID #: E3993
• Status: Completed
• Phase: Phase 3
• Start date: May 21, 1993
• Est. completion date: July 10, 2002

Study information

• Verified date: June 2023
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: July 10, 2002
• Est. primary completion date: July 10, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 56 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• GM-CSF priming

• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Cooperative Oncology Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rates		3 years