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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
N/A
Not Enrolling
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

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

- SGOT less than 3 times ULN

Renal:

- Creatinine less than 2 mg/dL

Cardiovascular:

- No clinically significant active cardiac disease

Pulmonary:

- No clinically significant active pulmonary disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No uncontrolled or active autoimmune disease

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jacob M. Rowe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rambam Health Care Campus

Authority:

United States: Federal Government

Study ID:

CDR0000068143

NCT ID:

NCT00006223

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Rhode Island HospitalProvidence, Rhode Island  02903
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
MBCCOP - Massey Cancer CenterRichmond, Virginia  23298-0037
Mount Sinai Medical Center, NYNew York, New York  10029
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lombardi Cancer CenterWashington, District of Columbia  20007
Veterans Affairs Medical Center - BirminghamBirmingham, Alabama  35233
Green Mountain Oncology GroupRutland, Vermont  05701
Veterans Affairs Medical Center - White River JunctionWhite River Junction, Vermont  05009
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Veterans Affairs Medical Center - Chicago (Westside Hospital)Chicago, Illinois  60612
Veterans Affairs Medical Center - San FranciscoSan Francisco, California  94121
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Veterans Affairs Medical Center - MemphisMemphis, Tennessee  38104
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Veterans Affairs Medical Center - TogusTogus, Maine  04330
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Columbia (Truman Memorial)Columbia, Missouri  65201
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Veterans Affairs Medical Center - BuffaloBuffalo, New York  14215
Veterans Affairs Medical Center - SyracuseSyracuse, New York  13210
Veterans Affairs Medical Center - DurhamDurham, North Carolina  27705
Schneider Children's Hospital at North ShoreManhasset, New York  11030