flt3L in Treating Patients With Acute Myeloid Leukemia - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborators:	National Cancer Institute (NCI) Cancer and Leukemia Group B Southwest Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006223

Purpose

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	Intervention	Phase
Leukemia	Biological: recombinant flt3 ligand	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission

Resource links provided by NLM:

Genetics Home Reference related topics: acute promyelocytic leukemia

MedlinePlus related topics: Acute Myeloid Leukemia Cancer Leukemia

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006223

Show 47 Study Locations

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Southwest Oncology Group

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00006223 History of Changes
Other Study ID Numbers:	CDR0000068143, ECOG-2998, CALGB-19903, SWOG-E2998
Study First Received:	September 11, 2000
Last Updated:	February 6, 2009
Health Authority:	United States: Federal Government

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:

Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Flt3 ligand protein

Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012