Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia
This study is ongoing, but not recruiting participants.
Sponsor:
University of Ulm
Information provided by (Responsible Party):
Dr. Richard Schlenk, University of Ulm
ClinicalTrials.gov Identifier:
NCT00151242
First received: September 6, 2005
Last updated: February 14, 2013
Last verified: October 2011
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Purpose
This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Drug: Cytarabine Drug: Idarubicin Drug: Etoposide Drug: All-trans retinoic acid Drug: Pegfilgrastim |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia |
Resource links provided by NLM:
Drug Information available for:
Cytarabine
Tretinoin
Etoposide
Idarubicin hydrochloride
Idarubicin
Etoposide phosphate
Pegfilgrastim
U.S. FDA Resources
Further study details as provided by University of Ulm:
Primary Outcome Measures:
- Complete remission (CR)-rate after induction therapy [ Time Frame: after the second induction cycle ] [ Designated as safety issue: No ]
- Relapse-free survival, one year after consolidation therapy with high-dose cytarabine considering different temporal sequences (1-3-5 versus 1-2-3) of the consolidation therapy [ Time Frame: One year after consolidation therapy ] [ Designated as safety issue: No ]
- Event-free survival [ Time Frame: two years ] [ 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: 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 ]
- Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle [ Time Frame: during consolidation therapy ] [ Designated as safety issue: Yes ]
- Timely sequence of the pegfilgrastim-concentration in correlation to the absolute neutrophil counts after each consolidation cycle [ Time Frame: during consolidation therapy ] [ Designated as safety issue: No ]
- Hematologic and non-hematologic toxicity after consolidation therapy with high-dose cytarabine considering the different consolidation schemes (day 1-3-5 versus day 1-2-3) [ Time Frame: during consolidation therapy ] [ Designated as safety issue: Yes ]
- Days in hospital after each consolidation cycle [ Time Frame: after consolidation therapy ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 920 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | August 2013 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Cytarabine
100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
Drug: Idarubicin
12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
Drug: Etoposide
100mg/m² i.v. day 1-3 (induction therapy)
Drug: Pegfilgrastim
6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
Other Name: Neulasta
|
| Experimental: 2 |
Drug: Cytarabine
100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
Drug: Idarubicin
12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
Drug: Etoposide
100mg/m² i.v. day 1-3 (induction therapy)
Drug: All-trans retinoic acid
45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)
Drug: Pegfilgrastim
6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
Other Name: Neulasta
|
Detailed Description:
First Induction Therapy:
- Cytarabine 100 mg/m² cont. i.v. days 1-7
- Idarubicin 12 mg/m² i.v. days 1,3,5
- Etoposide 100 mg/m² i.v. days 1-3
- ± ATRA 45 mg/m² p.o. days 6-8
- ATRA 15 mg/m² p.o. days 9-21
Second Induction Therapy:
- Cytarabine 100 mg/m² cont. i.v. days 1-7
- Idarubicin 12 mg/m² i.v. days 1 and 3
- Etoposide 100 mg/m² i.v. days 1-3
- ± ATRA 45 mg/m² p.o. days 6-8
- ATRA 15 mg/m² p.o. days 9-21
Consolidation Therapy:
cohort 1 (<= ID 336)
- Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5
- ± ATRA 15 mg/m² p.o. Tag 6-21
- Pegfilgrastim 6 mg s.c day 10
cohort 2 (> ID 336)
- Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3
- ± ATRA 15 mg/m² p.o. Tag 4-21
- Pegfilgrastim 6 mg s.c day 8
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| 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])
- Ages 18-60 years
- Written informed consent of each patient at study entry.
- Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories
Exclusion Criteria:
- Bleeding independent of the AML
- Acute promyelocytic leukemia
- Uncontrollable infection
- Participation in a concurrent clinical study
- Insufficiency of the kidneys (creatinine > 1.5x upper normal serum level), of the liver (bilirubin, AST or AP > 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure New York Heart Association (NYHA) III/IV
- Severe neurological or psychiatric disorder interfering with ability to give an informed consent.
- No consent for registration, storage and processing of the individual disease-characteristics and course.
- Performance status WHO > 2
- Pregnancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151242
Locations
| Austria | |
| Department of Hematology/Oncology, University Hospital 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 General Internal Medicine, University Hospital of Bonn | |
| Bonn, Germany, 53127 | |
| Medical Department I, Hospital Bremen-Mitte | |
| Bremen, Germany, 28177 | |
| Clinical Center of Hematology and Oncology, University Hospital of Düsseldorf | |
| Düsseldorf, Germany, 40225 | |
| Department of Hematology and Oncology, Hospital Essen Süd, Ev. Hospital of Essen-Werden | |
| Essen, Germany, 45239 | |
| Medical Department III, Hematology/Oncology, University of Frankfurt | |
| Frankfurt, Germany, 60590 | |
| Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst | |
| Frankfurt, Germany, 65929 | |
| Internal Medicine I, University of Freiburg | |
| Freiburg, Germany, 79106 | |
| 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 Göttingen | |
| Göttingen, Germany, 37075 | |
| Medical Department II, Hematology and Oncology, General Hospital Altona | |
| Hamburg, Germany, 22763 | |
| Department of Oncology and Hematology, University Hospital Eppendorf | |
| Hamburg, Germany, 20246 | |
| Medical Department III, Clinical Center Hanau | |
| Hanau, Germany, 63450 | |
| Medical Department III, Hospital Hannover-Siloah | |
| Hannover, Germany, 30449 | |
| Department of Hematology, Hematology and Oncology, Medizinische Hochschule Hannover | |
| Hannover, Germany, 30625 | |
| 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, Cartias Hospital Lebach | |
| Lebach, Germany, 66822 | |
| Department of Hematology and Oncology, Hospital of Lüdenscheid | |
| Lüdenscheid, Germany, 58505 | |
| Department of Hematology and Internal Oncology, University Hospital of Mainz | |
| Mainz, Germany, 55101 | |
| 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. Theresia | |
| Saarbrücken, Germany, 66113 | |
| Department of Oncology, Clinical Center of Stuttgart | |
| Stuttgart, Germany, 70174 | |
| Medical Department II, Diakonie Hospital | |
| Stuttgart, Germany, 70176 | |
| Medical Department I, Hospital of Barmherzige Brüder | |
| Trier, Germany, 54292 | |
| Department of Internal Medicine II, University Hospital of Tübingen | |
| Tübingen, Germany, 72076 | |
| Medical Clinic II-Hematology/Oncology, Hospital 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 by University of Ulm
Additional 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: | NCT00151242 History of Changes |
| Other Study ID Numbers: | AMLSG07-04 |
| Study First Received: | September 6, 2005 |
| Last Updated: | February 14, 2013 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Etoposide Idarubicin 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 Antineoplastic Agents, Phytogenic Antibiotics, Antineoplastic Keratolytic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013