Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2001 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003602

First received: November 1, 1999

Last updated: July 23, 2008

Last verified: January 2001

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

July 23, 2008

Start Date ^ICMJE

March 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003602 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Leukemia
Myelodysplastic Syndromes

Intervention ^ICMJE

Drug: cytarabine
Drug: etoposide
Drug: idarubicin
Drug: mitoxantrone hydrochloride

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

400

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00003602

Other Study ID Numbers ^ICMJE

CDR0000066675, RHG-AML97, EU-98031

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Riverside Haematology Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Graham Jackson, MD

Newcastle-upon-Tyne Hospitals NHS Trust

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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