Therapy-Optimization Trial for the Treatment of Acute Myeloid Leukemias (AML) in Children and Adolescents
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00111345 |
|
Recruitment Status
: Unknown
Verified March 2012 by University Hospital Muenster.
Recruitment status was: Active, not recruiting
First Posted
: May 20, 2005
Last Update Posted
: May 23, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Due to progressive therapy intensification in the four consecutive studies AML-BFM 78, 83, 93 and 98, prognosis for children with acute myeloid leukemia (AML) has improved steadily. In spite of the intensified therapy, rates of morbidity and mortality have remained unchanged or have even decreased. Against the background that about 40% of the patients still die from immediate causes of an underlying disease relapse or of nonresponse, it seems to be justifiable to intensify therapy - especially for high-risk patients - which on its parts will require an optimization of supportive measures. As the present risk stratification into standard- (SR) and high-risk (HR) patients has proved effective, we will pursue the risk-adapted therapy strategy.
The aim of the study is to improve prognosis in children with AML by intensification of cytostatic therapy and to evaluate by randomisation the equivalence of a prophylactic central nervous system (CNS) irradiation with a total dose of 18 Gy versus 12 Gy.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myeloid Leukemia | Drug: Anthracyclines Drug: liposomal daunorubicin Drug: 2-CDA Drug: AI | Phase 2 Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 550 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Multicenter Therapy-Optimization Trial AML-BFM 2004 for the Treatment of Acute Myeloid Leukemias in Children and Adolescents |
| Study Start Date : | March 2004 |
| Actual Primary Completion Date : | March 2012 |
| Estimated Study Completion Date : | March 2017 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 1
Daunoxome, standard risk
|
Drug: liposomal daunorubicin
3x80 mg/qm
Other Name: Daunoxome
|
|
Active Comparator: 2
Idarubicin, standard risk
|
Drug: Anthracyclines
3x12 mg/qm
Other Name: Idarubicin
|
|
Experimental: 3
Daunoxome, high-risk, 2-CDA
|
Drug: 2-CDA
2x6 mg/qm
Other Name: Cladribine
|
|
Active Comparator: 4
Idarubicin, high-risk, nothing
|
Drug: AI
AI
|
- Event-free and absolute survival from the date of diagnosis concerning objective 1 and from the date of randomisation concerning objective 2 [ Time Frame: 5 years ]
- Concerning objective 3: Disease-free survival from the date of randomisation [ Time Frame: 5 years ]
- Cardiotoxicity [ Time Frame: 5 years ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age from >0 to </=18 years
- De novo AML, including children with Down syndrome, primary myelosarcomas or acute mixed lineage leukemia/biphenotypic leukemia (predominantly myeloid)
- Admission to one of the member hospitals in Germany participating in the study AML-BFM 2004
Exclusion Criteria:
- Children with pre-existing syndromes (except Down syndrome)
- AML as secondary malignancy
- Accompanying diseases which do not allow therapy according to the protocol
- Pre-treatment for more than 14 days with another intensive induction therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111345
| Germany | |
| University Children's Hospital Muenster, Department of Paediatric Haematology and Oncology | |
| Muenster, North Rhine-Westphalia, Germany, D-48129 | |
| Principal Investigator: | Ursula Creutzig, Prof. Dr. med. | Medical School Hannover | |
| Principal Investigator: | Dirk Reinhardt, Prof. Dr. med. | Medical School Hanover |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital Muenster |
| ClinicalTrials.gov Identifier: | NCT00111345 History of Changes |
| Obsolete Identifiers: | NCT00478153 |
| Other Study ID Numbers: |
BfArM 4022064 DKH 50-2728 |
| First Posted: | May 20, 2005 Key Record Dates |
| Last Update Posted: | May 23, 2012 |
| Last Verified: | March 2012 |
Keywords provided by University Hospital Muenster:
|
Acute myeloid leukemia Acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Daunorubicin Idarubicin |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |