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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 3

Conditions: Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia

Treatments: Drug: Placebo; Drug: GM-CSF priming

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04446052

E3993

Details and patient eligibility

About

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

Enrollment: 362 patients

Sex: All

Ages: 56+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• N/A

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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362 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

GM-CSF priming

Active Comparator group

Treatment:

Drug: GM-CSF priming