NCT04446052

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 1993

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 1993

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2002

Completed
18 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

9.1 years

First QC Date

June 19, 2020

Last Update Submit

June 20, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • complete remission rates

    3 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

GM-CSF priming

ACTIVE COMPARATOR
Drug: GM-CSF priming

Interventions

GM-CSF primingDRUG
GM-CSF priming
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age56 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 24, 2020

Study Start

May 21, 1993

Primary Completion

July 10, 2002

Study Completion

July 10, 2002

Last Updated

June 22, 2023

Record last verified: 2023-06