Combination Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia

• Sponsor: Riverside Haematology Group (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00003602
• Collaborator: (none)
• Enrollment: 400
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia; Myelodysplastic Syndromes	Drug: cytarabine; Drug: etoposide; Drug: idarubicin; Drug: mitoxantrone hydrochloride	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Newcastle Upon Tyne Hospitals NHS Trust	Newcastle-Upon-Tyne	England	United Kingdom	NE7 7DN

Sponsors and Collaborators

• Riverside Haematology Group

Investigators

• Study Chair: Graham Jackson, MD, Newcastle-upon-Tyne Hospitals NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00003602
• Other Study ID Numbers: CDR0000066675; RHG-AML97; EU-98031
• First Posted: Jan 27, 2003
• Last Update Posted: Sep 20, 2013
• Last Verified: Jan 1, 2001

• Keywords provided by , ,: 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
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes; Syndrome; Cytarabine; Etoposide; Mitoxantrone; Idarubicin

Study Results

No Results Posted as of Sep 20, 2013