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A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission

Phase 3
18 Years
Not Enrolling

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Trial Information

A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission


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

- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jacob M. Rowe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rambam Health Care Campus


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

January 2007

Related Keywords:

  • Leukemia
  • 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)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
University of Chicago Cancer Research Center Chicago, Illinois  60637
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Rhode Island Hospital Providence, Rhode Island  02903
Vermont Cancer Center Burlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
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CCOP - Mount Sinai Medical Center Miami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Ellis Fischel Cancer Center - Columbia Columbia, Missouri  65203
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
CCOP - North Shore University Hospital Manhasset, New York  11030
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
MBCCOP - Massey Cancer Center Richmond, Virginia  23298-0037
Mount Sinai Medical Center, NY New York, New York  10029
New York Presbyterian Hospital - Cornell Campus New York, New York  10021
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Lombardi Cancer Center Washington, District of Columbia  20007
Veterans Affairs Medical Center - Birmingham Birmingham, Alabama  35233
Green Mountain Oncology Group Rutland, Vermont  05701
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Dana-Farber Cancer Institute Boston, Massachusetts  02115
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CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse, New York  13217
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Veterans Affairs Medical Center - Richmond Richmond, Virginia  23249
Veterans Affairs Medical Center - Togus Togus, Maine  04330
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
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University of Nebraska Medical Center Omaha, Nebraska  68198-3330
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