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

• Sponsor: Eastern Cooperative Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT04446052
• Collaborator: (none)
• Enrollment: 362
• Arms: 2
• Actual Duration (Months): 110.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Adult Patients (Over 55) With Acute Non-Lymphocytic Leukemia	Drug: GM-CSF priming; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 362 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 24, 1993
• Actual Primary Completion Date: Jul 10, 2002
• Actual Study Completion Date: Jul 10, 2002

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Active Comparator: GM-CSF priming	Drug: GM-CSF priming

Outcome Measures

Primary Outcome Measures

1. complete remission rates [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 56 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Eastern Cooperative Oncology Group

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eastern Cooperative Oncology Group
• ClinicalTrials.gov Identifier: NCT04446052
• Other Study ID Numbers: E3993
• First Posted: Jun 24, 2020
• Last Update Posted: Jun 24, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid, Acute; Leukemia, Myeloid

Study Results

No Results Posted as of Jun 24, 2020