flt3L in Treating Patients With Acute Myeloid Leukemia

Study Overview
=================
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.

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

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Biological: recombinant flt3 ligand


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: recombinant flt3 ligand|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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)