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

June 20, 2023 updated by: Eastern Cooperative Oncology Group

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete remission rates
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 1993

Primary Completion (Actual)

July 10, 2002

Study Completion (Actual)

July 10, 2002

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E3993

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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