flt3L in Treating Patients With Acute Myeloid Leukemia

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00006223

Collaborator

National Cancer Institute (NCI) (NIH), Cancer and Leukemia Group B (Other), Southwest Oncology Group (Other)

Locations

Duration (Months)

Study Details

Study Description

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

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 Design

Study Type:

Interventional

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 :

Jul 1, 2000

Actual Study Completion Date :

Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center - Birmingham	Birmingham	Alabama	United States	35233-1996
2	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
3	Veterans Affairs Medical Center - San Francisco	San Francisco	California	United States	94121
4	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94143-0128
5	CCOP - Christiana Care Health Services	Wilmington	Delaware	United States	19899
6	Lombardi Cancer Center	Washington	District of Columbia	United States	20007
7	Walter Reed Army Medical Center	Washington	District of Columbia	United States	20307-5000
8	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
9	Veterans Affairs Medical Center - Chicago (Westside Hospital)	Chicago	Illinois	United States	60612
10	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
11	Holden Comprehensive Cancer Center at The University of Iowa	Iowa City	Iowa	United States	52242-1009
12	Veterans Affairs Medical Center - Togus	Togus	Maine	United States	04330
13	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
14	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02115
15	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts	United States	01655
16	Veterans Affairs Medical Center - Minneapolis	Minneapolis	Minnesota	United States	55417
17	University of Minnesota Cancer Center	Minneapolis	Minnesota	United States	55455
18	Veterans Affairs Medical Center - Columbia (Truman Memorial)	Columbia	Missouri	United States	65201
19	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri	United States	65203
20	Barnes-Jewish Hospital	Saint Louis	Missouri	United States	63110
21	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-3330
22	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada	United States	89106
23	Norris Cotton Cancer Center	Lebanon	New Hampshire	United States	03756-0002
24	Veterans Affairs Medical Center - Buffalo	Buffalo	New York	United States	14215
25	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
26	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
27	Schneider Children's Hospital at North Shore	Manhasset	New York	United States	11030
28	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
29	New York Presbyterian Hospital - Cornell Campus	New York	New York	United States	10021
30	Mount Sinai Medical Center, NY	New York	New York	United States	10029
31	State University of New York - Upstate Medical University	Syracuse	New York	United States	13210
32	Veterans Affairs Medical Center - Syracuse	Syracuse	New York	United States	13210
33	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
34	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina	United States	27599-7295
35	Veterans Affairs Medical Center - Durham	Durham	North Carolina	United States	27705
36	Duke Comprehensive Cancer Center	Durham	North Carolina	United States	27710
37	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
38	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
39	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio	United States	43210-1240
40	Rhode Island Hospital	Providence	Rhode Island	United States	02903
41	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee	United States	38103
42	Veterans Affairs Medical Center - Memphis	Memphis	Tennessee	United States	38104
43	Green Mountain Oncology Group	Bennington	Vermont	United States	05201
44	Vermont Cancer Center	Burlington	Vermont	United States	05401-3498
45	Veterans Affairs Medical Center - White River Junction	White River Junction	Vermont	United States	05009
46	Veterans Affairs Medical Center - Richmond	Richmond	Virginia	United States	23249
47	MBCCOP - Massey Cancer Center	Richmond	Virginia	United States	23298-0037