Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.

flt3L in Treating Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006223
Recruitment Status : Completed
First Posted : September 3, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Southwest Oncology Group
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: recombinant flt3 ligand Phase 3

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission
Study Start Date : July 2000
Actual Study Completion Date : January 2007

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete remission (CR)

    • Must be at least 60 years of age if first CR
    • Must have had histological proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of one of the following prior to achieving CR:

      • Acute myeloblastic leukemia (M0, M1, M2)
      • Acute promyelocytic leukemia (M3)
      • Acute myelomonocytic leukemia (M4)
      • Acute monocytic leukemia (M5)
      • Acute erythroleukemia (M6)
      • Acute megakaryocytic leukemia (M7)
      • Refractory anemia with excess blasts in transformation



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin less than 3 times upper limit of normal (ULN)
  • SGOT less than 3 times ULN


  • Creatinine less than 2 mg/dL


  • No clinically significant active cardiac disease


  • No clinically significant active pulmonary disease


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No uncontrolled or active autoimmune disease


Biologic therapy:

  • Prior autologous bone marrow transplantation (BMT) allowed
  • No prior allogeneic BMT
  • Other prior immunotherapy allowed if not received during the most recent treatment


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006223

Show Show 47 study locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Southwest Oncology Group
Layout table for investigator information
Study Chair: Jacob M. Rowe, MD Rambam Health Care Campus
Study Chair: Richard A. Larson, MD University of Chicago
Study Chair: John E. Godwin, MD, MS Loyola University

Layout table for additonal information Identifier: NCT00006223    
Other Study ID Numbers: CDR0000068143
First Posted: September 3, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: September 2006
Keywords provided by National Cancer Institute (NCI):
adult acute myeloid leukemia in remission
adult acute erythroid leukemia (M6)
adult acute myeloblastic leukemia without maturation (M1)
adult acute myeloblastic leukemia with maturation (M2)
adult acute promyelocytic leukemia (M3)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute megakaryoblastic leukemia (M7)
adult acute monocytic leukemia (M5b)
adult acute minimally differentiated myeloid leukemia (M0)
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Flt3 ligand protein
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents