|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group 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: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission |
| Study Start Date: | July 2000 |
OBJECTIVES:
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.
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 |
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia in first, second, third, or subsequent complete remission (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:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Show 47 Study Locations| 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
| Study ID Numbers: | CDR0000068143, ECOG-2998, CALGB-19903, SWOG-E2998 |
| Study First Received: | September 11, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006223 History of Changes |
| Health Authority: | United States: Federal Government |
|
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) |
|
Flt3 ligand protein Leukemia, Monocytic, Acute Radiation-Protective Agents Immunologic Factors Adjuvants, Immunologic Acute Myelomonocytic Leukemia Leukemia, Myeloid Acute Monoblastic Leukemia Leukemia, Myeloid, Acute |
Leukemia, Myelomonocytic, Acute Leukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Leukemia, Erythroblastic, Acute Acute Myeloid Leukemia, Adult Leukemia, Promyelocytic, Acute Acute Promyelocytic Leukemia Di Guglielmo's Syndrome |
|
Flt3 ligand protein Leukemia Radiation-Protective Agents Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Adjuvants, Immunologic Leukemia, Myeloid Leukemia, Myeloid, Acute Protective Agents Pharmacologic Actions |