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Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: European Organization for Research and Treatment of Cancer
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002719
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in the bone marrow or peripheral blood and may help a person's immune system recover after chemotherapy and radiation therapy. Combining more than one drug and giving drugs in different ways may kill more cancer cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without G-CSF in treating older patients with acute myeloid leukemia.


Condition Intervention Phase
Leukemia
Neutropenia
Drug: amsacrine
Drug: carmustine
Drug: cytarabine
Drug: etoposide
Drug: filgrastim
Drug: idarubicin
Drug: mitoxantrone hydrochloride
Procedure: peripheral blood stem cell transplantation
Phase III

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

ChemIDplus related topics:   Filgrastim    Cytarabine    Cytarabine hydrochloride    Etoposide    Idarubicin    Idarubicin hydrochloride    Carmustine    Mitoxantrone hydrochloride    Mitoxantrone    Granulocyte colony-stimulating factor    Etoposide phosphate    Amsacrine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized
Official Title:   RANDOMIZED PHASE III STUDY TO EVALUATE THE VALUE OF rHuG-CSF IN INDUCTION AND OF AN ORAL SCHEDULE AS CONSOLIDATION TREATMENT IN ELDERLY PATIENTS WITH ACUTE MYELOGENOUS LEUMEKIA (AML-13 PROTOCOL)

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   500
Study Start Date:   December 1995

Detailed Description:

OBJECTIVES: I. Assess the role of granulocyte colony-stimulating factor given during and/or after remission induction with MICE (mitoxantrone/cytarabine/etoposide) in elderly patients with acute myelogenous leukemia (AML). II. Compare the complete remission (CR) rate and survival of these patients when treated with nearly equivalent doses of oral vs. intravenous mini-ICE (idarubicin/cytarabine/etoposide) as consolidation therapy given on an outpatient basis. III. Evaluate the feasibility of a second intensive consolidation regimen consisting of BAVC (carmustine/amsacrine/etoposide/cytarabine) followed by autologous stem cell support in patients under age 71 who are in CR and have good performance status.

OUTLINE: Randomized study. All patients are randomly assigned to Arms IA through ID for Induction. Patients who achieve CR and who have adequate organ function and performance status are then randomly assigned to Arm IIA or IIB for Consolidation. At selected centers, patients in CR after their first Consolidation course who are under age 71 and in very good clinical condition are treated on Regimen A (in lieu of a second Consolidation course). The following acronyms are used: AMSA Amsacrine, NSC-249992 ARA-C Cytarabine, NSC-63878 BAVC BCNU/AMSA/VP-16/ARA-C BCNU Carmustine, NSC-409962 DHAD Mitoxantrone, NSC-301739 G-CSF Granulocyte Colony-Stimulating Factor (Rhone-Poulenc Rorer) IDA Idarubicin, NSC-256439 MICE DHAD/ARA-C/VP-16 Mini-ICE IDA/ARA-C/VP-16 PBSC Peripheral Blood Stem Cells VP-16 Etoposide, NSC-141540 INDUCTION: Arm IA: 3-Drug Combination Chemotherapy. MICE. Arm IB: 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation. MICE; plus G-CSF. G-CSF during chemotherapy. Arm IC: 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation. MICE; plus G-CSF. G-CSF after chemotherapy. Arm ID: 3-Drug Combination Chemotherapy plus Hematologic Toxicity Attenuation. MICE; plus G-CSF. G-CSF during and after chemotherapy. CONSOLIDATION: Arm IIA: 3-Drug Combination Chemotherapy. Mini-ICE. Intravenous IDA/VP-16/ARA-C. Arm IIB: 3-Drug Combination Chemotherapy. Mini-ICE. Oral IDA/VP-16 + subcutaneous ARA-C. Regimen A: Stem Cell Mobilization followed by 4-Drug Combination Myeloablative Chemotherapy with Stem Cell Rescue. G-CSF; followed by BAVC; with PBSC.

PROJECTED ACCRUAL: 500 patients will be randomized for Induction, of whom an anticipated 238 patients will be randomized for Consolidation. If at interim analyses survival is shorter on Regimen A, that regimen will be closed.

  Eligibility
Ages Eligible for Study:   61 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Acute myeloblastic leukemia (AML) At least 30% blast cells in bone marrow smear Secondary AML eligible, as follows: Secondary to myelodysplastic syndrome (but not other myeloproliferative diseases) Secondary to cured Hodgkin's disease or other cured malignancy Secondary to alkylating agents or radiation for other reasons Acute promyelocytic leukemia (M3) referred to the collaborative Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto-EORTC protocol (EORTC-06952) No blast crisis of chronic myeloid leukemia

PATIENT CHARACTERISTICS: Age: 61 to 80 Performance status: WHO 0-2 Life expectancy: No marked impairment from disease other than AML Hematopoietic: Not applicable Hepatic: Bilirubin less than 2 x ULN Renal: Creatinine less than 2 x ULN Cardiovascular: LVEF at least 50% No severe cardiac disease Pulmonary: No severe pulmonary disease Other: HIV seronegative (if tested) No uncontrolled infection No severe neurologic, metabolic, or psychiatric disease No other concomitant disease that precludes protocol therapy No other progressive malignant disease

PRIOR CONCURRENT THERAPY: No prior chemotherapy

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002719

Locations
Italy
Azienda Policlinico Umberto Primo    
      Rome, Italy, 00161

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators
Study Chair:     Roel Willemze, MD, PhD     Leiden University Medical Center    
Study Chair:     Franco Mandelli, MD     Azienda Policlinico Umberto Primo    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000064570, EORTC-06954, ITA-GIMEMA-AML13
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002719
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia  
adult acute erythroid leukemia (M6)  
adult acute myeloblastic leukemia without maturation (M1)  
adult acute myeloblastic leukemia with maturation (M2)  
adult acute myelomonocytic leukemia (M4)  
adult acute monoblastic leukemia (M5a)  
adult acute megakaryoblastic leukemia (M7)
secondary acute myeloid leukemia
adult acute monocytic leukemia (M5b)
neutropenia
adult acute minimally differentiated myeloid leukemia (M0)

Study placed in the following topic categories:
Leukemia, Monocytic, Acute
Acute myelomonocytic leukemia
Amsacrine
Leukocyte Disorders
Leukemia, Myeloid, Acute
Di Guglielmo's syndrome
Granulocytopenia
Etoposide phosphate
Leukemia
Neoplasm Metastasis
Acute erythroblastic leukemia
Acute myeloid leukemia, adult
Acute myelocytic leukemia
Etoposide
Cytarabine
Hematologic Diseases
Carmustine
Agranulocytosis
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myelomonocytic, Acute
Neutropenia
Idarubicin
Leukemia, Erythroblastic, Acute
Mitoxantrone
Leukopenia
Acute monoblastic leukemia

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Antineoplastic Agents, Alkylating
Central Nervous System Agents
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2008




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