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| Sponsored by: |
Riverside Haematology Group |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003602 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating older patients with acute myeloid leukemia.
PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating older patients with acute myeloid leukemia in first remission.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: cytarabine Drug: etoposide Drug: idarubicin Drug: mitoxantrone hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Randomised Study Comparing an Oral Regimen (Idarubicin and Etoposide) With an Intravenous Regimen (MAE) for Consolidation in Patients Over 55 Years With Acute Myeloid Leukaemia in First Complete Remission |
| Estimated Enrollment: | 400 |
| Study Start Date: | March 1998 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to number of courses of induction therapy required to achieve complete remission.
All patients receive induction chemotherapy consisting of idarubicin IV on days 1-3 and cytarabine IV over 12 hours on days 1-7. Patients receive 1-2 courses of induction chemotherapy to achieve complete remission.
Patients are randomized to one of two treatment arms for consolidation therapy after achieving complete remission.
Quality of life is assessed before each course of consolidation chemotherapy and 6-8 weeks after completion of therapy.
Patients are followed until death.
PROJECTED ACCRUAL: Approximately 400 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed de novo or secondary acute myeloid leukemia (AML)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United Kingdom, England | |
| Newcastle Upon Tyne Hospitals NHS Trust | |
| Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN | |
| Study Chair: | Graham Jackson, MD | Newcastle-upon-Tyne Hospitals NHS Trust |
More Information
| Study ID Numbers: | CDR0000066675, RHG-AML97, EU-98031 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00003602 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated adult acute myeloid leukemia refractory anemia with excess blasts refractory anemia with excess blasts in transformation |
secondary acute myeloid leukemia de novo myelodysplastic syndromes secondary myelodysplastic syndromes |
|
Antimetabolites Anti-Infective Agents Precancerous Conditions Immunologic Factors Leukemia, Myeloid, Acute Etoposide phosphate Refractory Anemia Anti-Bacterial Agents Leukemia Acute Myelocytic Leukemia Preleukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Neoplasm Metastasis Analgesics |
Etoposide Cytarabine Hematologic Diseases Myelodysplastic Syndromes Anemia Leukemia, Myeloid Antiviral Agents Immunosuppressive Agents Idarubicin Peripheral Nervous System Agents Anemia, Refractory, with Excess of Blasts Mitoxantrone Bone Marrow Diseases Antineoplastic Agents, Phytogenic |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Precancerous Conditions Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Leukemia, Myeloid, Acute Leukemia Preleukemia Pathologic Processes Sensory System Agents Syndrome |
Therapeutic Uses Analgesics Etoposide Cytarabine Disease Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Leukemia, Myeloid Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Idarubicin Peripheral Nervous System Agents |
