All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia
This study has been completed.
Sponsor:
University of Ulm
Information provided by (Responsible Party):
Dr. Richard Schlenk, University of Ulm
ClinicalTrials.gov Identifier:
NCT00151255
First received: September 6, 2005
Last updated: October 12, 2011
Last verified: October 2011
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Purpose
This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Drug: Cytarabine Drug: Idarubicin Drug: All-trans retinoic acid Drug: Mitoxantrone Drug: Etoposid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
core binding factor acute myeloid leukemia
cytogenetically normal acute myeloid leukemia
familial acute myeloid leukemia with mutated CEBPA
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
U.S. FDA Resources
Further study details as provided by University of Ulm:
Primary Outcome Measures:
- event-free survival [ Time Frame: one year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs [ Time Frame: during therapy ] [ Designated as safety issue: Yes ]
- complete remission (CR) rate after induction therapy [ Time Frame: after second induction cycle ] [ Designated as safety issue: No ]
- cumulative incidence of relapse [ Time Frame: two years ] [ Designated as safety issue: No ]
- cumulative incidence of death [ Time Frame: two years ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: two years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2004 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Cytarabine
100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)
Drug: Idarubicin
12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)
Drug: All-trans retinoic acid
45mg/m² p.o. day 4-6, 15mg/m² p.o. day 7-28 (induction therapy); 15mg/m² p.o. day 4-28 (consolidation therapy)
Drug: Mitoxantrone
10mg/m² i.v. day 2-3 (first consolidation cycle)
Drug: Etoposid
100mg/m² i.v. Tag 1-5 (second consolidation cycle)
First Induction Therapy:
- Cytarabine 100 mg/m² cont. i.v. days 1-5
-
Idarubicin 12 mg/m² i.v. days 1, 3
- ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28
Second Induction Therapy:
- Cytarabine 100 mg/m² cont. i.v. days 1-5
-
Idarubicin 12 mg/m² i.v. days 1, 3
- ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28
First Consolidation Therapy:
- Cytarabine 1000 mg/m² bid i.v. days 1-3
-
Mitoxantrone 10 mg/m² i.v. days 2, 3
- ATRA 15 mg/m² p.o. days 4-28
Second Consolidation Therapy
- Etoposide 100 mg/m² i.v. days 1-5
-
Idarubicin 12 mg/m² i.v. days 1,3
- ATRA 15 mg/m² p.o. days 4-28
Eligibility| Ages Eligible for Study: | 61 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Newly diagnosed AML defined according to the World Health Organization (WHO) classification (excluding acute promyelocytic leukemia [APL])
- Aged > 60 years
- All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
- Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.
Exclusion Criteria:
- Bleeding independent of the AML
- Acute promyelocytic leukemia
- Uncontrolled infection
- Participation in a concurrent clinical study
- Insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association [NYHA] III/IV
- Severe neurological or psychiatric disorder interfering with ability of giving informed consent
- No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
- Performance status WHO > 2
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151255
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151255
Locations
| Austria | |
| Department of Hematology/Oncology, University Hospital of Innsbruck | |
| Innsbruck, Austria, 6020 | |
| Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern | |
| Linz, Austria, 4010 | |
| Medical Department III, St. Johann Hospital | |
| Salzburg, Austria, 5020 | |
| Center of hematology and oncology, Hanusch Hospital | |
| Wien, Austria, 1140 | |
| Germany | |
| Department of Internal Medicine I, Central Hospital of Augsburg | |
| Augsburg, Germany, 86856 | |
| Department of General Internal Medicine, University Hospital of Bonn | |
| Bonn, Germany, 53127 | |
| Medical Department I, Hospital of Bremen-Mitte | |
| Bremen, Germany, 28177 | |
| Department of Hematology and Oncology, Hospital Essen-Süd, Ev. Hospital of Essen-Werden | |
| Essen, Germany, 45239 | |
| Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst | |
| Frankfurt, Germany, 65929 | |
| Medical Department IV, University Hospital of Giessen | |
| Giessen, Germany, 35392 | |
| Department of Internal Medicine, Wilhelm-Anton Hospital gGmbH | |
| Goch, Germany, 47574 | |
| Centre of Internal Medicine, University Hospital of Göttingen | |
| Göttingen, Germany, 37075 | |
| Department of Oncology and Hematology, University Hospital Eppendorf | |
| Hamburg, Germany, 20246 | |
| Medical Department II, General Hospital Altona | |
| Hamburg, Germany, 22763 | |
| Medical Department III, Hospital of Hanau | |
| Hanau, Germany, 63450 | |
| Medical Department III, Hospital of Hannover-Siloah | |
| Hannover, Germany, 30449 | |
| Department of Internal Medicine I, University Hospital of Saarland | |
| Homburg, Germany, 66421 | |
| Medical Department II, City Hospital Karlsruhe gGmbH | |
| Karlsruhe, Germany, 76133 | |
| Medical Department II, University Hospital of Kiel | |
| Kiel, Germany, 24116 | |
| Department of Internal Medicine/Hematology and Oncology, Caritas Hospital Lebach | |
| Lebach, Germany, 66822 | |
| Department of Hematology/Oncology, Clinical Center of Lüdenscheid | |
| Lüdenscheid, Germany, 58515 | |
| Medical Department III, Clinical Center Rechts der Isar | |
| München, Germany, 81675 | |
| Department of Hematology and Oncology, Clinical Center of Oldenburg gGmbH | |
| Oldenburg, Germany, 26133 | |
| Department of Hematology and Oncology/Caritas Hospital St. Theresa | |
| Saarbrücken, Germany, 66113 | |
| Department of Oncology, Clinical Center of Stuttgart | |
| Stuttgart, Germany, 70174 | |
| Medical Department II, Diakonie Hospital | |
| Stuttgart, Germany, 70176 | |
| I. Medical Department, Hospital of Barmerzigen Brüder | |
| Trier, Germany, 54292 | |
| Medical Center II - Hematology/Oncology, Clinical Center Villingen-Schwenningen | |
| Villingen - Schwenningen, Germany, 78050 | |
| Medical Department I, Helios Hospital Wuppertal | |
| Wuppertal, Germany, 42283 | |
Sponsors and Collaborators
University of Ulm
Investigators
| Principal Investigator: | Richard F Schlenk, Dr. | Department of Internal Medicine III, University of Ulm |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Richard Schlenk, PD Dr., University of Ulm |
| ClinicalTrials.gov Identifier: | NCT00151255 History of Changes |
| Other Study ID Numbers: | AMLSG06-04 |
| Study First Received: | September 6, 2005 |
| Last Updated: | October 12, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by University of Ulm:
|
age > 60 years |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Cytarabine Mitoxantrone Idarubicin Tretinoin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents |
Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Antibiotics, Antineoplastic Keratolytic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on September 28, 2016