flt3L in Treating Patients With Acute Myeloid Leukemia

Phase 3

Completed

• Conditions: Leukemia

• Registration Number: NCT00006223
• Lead Sponsor: Eastern Cooperative Oncology Group

Brief Summary

RATIONALE: Drugs such as flt3L may stimulate a person's immune system and help kill cancer cells. It is not yet known if flt3L is effective in treating acute myeloid leukemia.

PURPOSE: Randomized phase III trial to determine the effectiveness of flt3L in treating patients who have acute myeloid leukemia that is in remission.

Detailed Description

OBJECTIVES:

* Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone.

* Compare the long-term immunologic effects of these regimens in these patients.

* Compare the long-term safety and toxicity of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to complete remission (CR) (first vs second vs third or subsequent) and post-remission therapy (yes vs no). Patients are randomized to one of two treatment arms.

* Arm I: Patients receive flt3 ligand subcutaneously daily on days 1-14. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

* Arm II: Patients undergo observation alone. Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 139 patients will be accrued for this study within approximately 28 months.

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2000-09-11
• Study First Submitted QC: 2003-09-02
• Study First Posted: 2003-09-03
• Status Verified: 2006-09
• Study Completion: 2007-01
• Last Update Submitted: 2013-06-20
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (47)

Veterans Affairs Medical Center - Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California San Diego Cancer Center; 🇺🇸 La Jolla, California, United States

Veterans Affairs Medical Center - San Francisco; 🇺🇸 San Francisco, California, United States

UCSF Cancer Center and Cancer Research Institute; 🇺🇸 San Francisco, California, United States

CCOP - Christiana Care Health Services; 🇺🇸 Wilmington, Delaware, United States

Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Walter Reed Army Medical Center; 🇺🇸 Washington, District of Columbia, United States

CCOP - Mount Sinai Medical Center; 🇺🇸 Miami Beach, Florida, United States

Veterans Affairs Medical Center - Chicago (Westside Hospital); 🇺🇸 Chicago, Illinois, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Scroll for more (37 remaining)