A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)

July 13, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

RATIONALE: Patient abstract not available

PURPOSE: Patient abstract not available

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Assess the value (in terms of disease-free survival and overall survival) of short intensive consolidation with high-dose cytosine arabinoside in patients with acute myelogenous leukemia who achieve complete remission after induction with daunorubicin and cytosine arabinoside. II. Assess the toxicity and resulting quality of life associated with consolidation with high-dose cytosine arabinoside compared with conventional consolidation/maintenance treatment. III. Determine whether addition of granulocyte-macrophage colony stimulating factor (GM-CSF) to Induction chemotherapy can improve therapeutic results through activation of leukemic cells into the cell cycle and/or acceleration of hematopoietic recovery (objective added 08/90). IV. Determine indirectly whether autologous bone marrow therapy is better than conventional consolidation/maintenance or high-dose cytosine arabinoside by comparing results from protocol EORTC-06863 (AML 8 A).

OUTLINE: Patients with normal kidney function are randomized on Arms A-D for Induction (patients whose serum creatinine is more than 1.5 x the upper limit of normal are nonrandomly assigned to Arm A). Following Induction, patients achieving CR are randomized to Arms I and II. Induction: Arm A: 2-Drug Combination Chemotherapy. Daunorubicin, Daunomycin, DNM, DNR, NSC-82151; Cytosine arabinoside, ARA-C, NSC-63878. Arm B: 2-Drug Combination Chemotherapy plus Growth Factor Therapy. DNM; ARA-C; plus Granulocyte-Macrophage Colony Stimulating Factor (Sandoz), GM-CSF. GM-CSF on days 0 through 7. Arm C: 2-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. DNM; ARA-C; GM-CSF. GM-CSF from end of chemotherapy through day 28. Arm D: 2-Drug Combination Chemotherapy plus Growth Factor Therapy and Hematologic Toxicity Attenuation. DNM; ARA-C; GM-CSF. GM-CSF on days 0 through 28. Arm I: Intensive Consolidation: 2-Drug Combination Chemotherapy followed by 2-Drug Combination Chemotherapy. High-dose ARA-C, HDARA-C; Acridinylanisidide, m-AMSA, AMSA, NSC-249992; followed by HDARA-C; DNR. Arm II: Standard Consolidation/Maintenance: 2-Drug Combination Chemotherapy. ARA-C; DNR.

PROJECTED ACCRUAL: A minimum of 157 patients will be required; with an expected entry rate of 40 patients per year, patient entry is expected to take 4 years.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Newly diagnosed, untreated acute myelogenous leukemia (AML), as follows: Any cytological type according to the FAB classification At least 30% blast cells in bone marrow smear required Secondary acute leukemia eligible, i.e.: AML cured Hodgkin's disease or other malignancy AML following exposure to alkylating agents or radiation The following are specifically excluded: Blast crisis of chronic myeloid leukemia Leukemia supervening after other myeloproliferative disease Leukemia supervening after overt myelodysplastic disorder (e.g., refractory anemia with excess blasts) of more than 6 months' duration

PATIENT CHARACTERISTICS: Age: 45-60 Patients 10-45 are eligible for EORTC-06863 Performance status: Not specified Hematopoietic: Not specified Hepatic: No severe concomitant hepatic disease Renal: No severe concomitant renal disease Cardiovascular: No severe concomitant cardiac disease Other: No severe concomitant neurological disease No other progressive malignant disease

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior chemotherapy Endocrine therapy: No more than 7 days of corticosteroids for AML Radiotherapy: No prior radiotherapy Surgery: Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Toxicity
Quality of life
Disease-free survival and overall survival in patients who achieve complete remission after induction
Improved therapeutic results as measured by activation of leukemic cells into the cell cycle and/or acceleration of hematopoietic recovery
Relative efficacy of autologous bone marrow therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Robert A. Zittoun, MD, Hotel Dieu de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1986

Primary Completion (Actual)

June 1, 1994

Study Registration Dates

First Submitted

March 25, 2011

First Submitted That Met QC Criteria

March 25, 2011

First Posted (Estimate)

March 28, 2011

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 13, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-06864

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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