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:
Drug Information available for:
Cytarabine
Tretinoin
Idarubicin hydrochloride
Idarubicin
Mitoxantrone
Mitoxantrone hydrochloride
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 |
| 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
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:
No publications provided
| 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, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Idarubicin Mitoxantrone Tretinoin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents |
Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antibiotics, Antineoplastic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Keratolytic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013