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Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

NCT ID: NCT00003602

Last Updated: 2013-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Brief Summary

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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

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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.

Conditions

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Leukemia Myelodysplastic Syndromes

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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cytarabine

Intervention Type DRUG

etoposide

Intervention Type DRUG

idarubicin

Intervention Type DRUG

mitoxantrone hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riverside Haematology Group

OTHER

Sponsor Role lead

Principal Investigators

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Graham Jackson, MD

Role: STUDY_CHAIR

Newcastle-upon-Tyne Hospitals NHS Trust

Locations

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Newcastle Upon Tyne Hospitals NHS Trust

Newcastle upon Tyne, England, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RHG-AML97

Identifier Type: -

Identifier Source: secondary_id

EU-98031

Identifier Type: -

Identifier Source: secondary_id

CDR0000066675

Identifier Type: -

Identifier Source: org_study_id