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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


Phase 3
55 Years
N/A
Open (Enrolling)
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

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


OBJECTIVES:

- Compare the efficacy of oral idarubicin and etoposide vs intravenous mitoxantrone,
etoposide, and cytarabine as consolidation therapy in patients over 55 years old with
acute myeloid leukemia in first complete remission.

- Compare the toxicity of these 2 regimens in these patients.

- Assess the quality of life of these patients.

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.

- Arm I: Patients receive 2 courses of mitoxantrone IV on days 1 and 2, etoposide IV over
1 hour on days 1-5, and cytarabine IV over 12 hours on days 1-5.

- Arm II: Patients receive 2 courses of oral idarubicin and etoposide on days 1-3.

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed de novo or secondary acute myeloid leukemia (AML)

- Prior myelodysplasia allowed

- Refractory anemia with excess blasts (RAEB) OR

- RAEB in transformation

- No relapsed AML

- No chronic granulocytic leukemia in transformation

- No CNS disease

PATIENT CHARACTERISTICS:

Age:

- Over 55

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- Transaminases no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 2.5 times ULN

Cardiovascular:

- No severe or uncontrolled cardiac failure

Other:

- No serious medical, social, or psychological condition

- Not HIV 1 or 2 seropositive

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No plan for future autograft

Chemotherapy:

- No prior chemotherapy for myelodysplastic syndrome or AML

Endocrine therapy:

- Not specifed

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No concurrent aluminum or magnesium-based antacids

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Graham Jackson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Newcastle-upon-Tyne Hospitals NHS Trust

Authority:

United States: Federal Government

Study ID:

CDR0000066675

NCT ID:

NCT00003602

Start Date:

March 1998

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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