Treatment Outcome in Elderly Patients
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| ClinicalTrials.gov Identifier: NCT00700544 |
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Recruitment Status :
Completed
First Posted : June 18, 2008
Last Update Posted : June 18, 2008
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Sponsor:
University Hospital, Grenoble
Collaborators:
French Innovative Leukemia Organisation
BGMT
Information provided by:
University Hospital, Grenoble
| Tracking Information | ||||||||||
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| First Submitted Date ICMJE | June 13, 2008 | |||||||||
| First Posted Date ICMJE | June 18, 2008 | |||||||||
| Last Update Posted Date | June 18, 2008 | |||||||||
| Study Start Date ICMJE | June 2002 | |||||||||
| Actual Primary Completion Date | April 2005 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
The primary objective of this study was to assess the ability of androgens to increase DFS. [ Time Frame: 3 years ] | |||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy [ Time Frame: 3 years ] | |||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Treatment Outcome in Elderly Patients | |||||||||
| Official Title ICMJE | Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial. | |||||||||
| Brief Summary | A multicenter randomized trial evaluating the possible benefit of androgens during post remission therapy in an attempt to improve the outcome of AML in older patients.All patients received the ICL regimen as induction and were randomized to receive, after achieving CR or PR, a maintenance therapy including or not androgens. Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years | |||||||||
| Detailed Description |
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| Study Type ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 3 | |||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Pigneux A, Bene MC, Guardiola P, Recher C, Hamel JF, Sauvezie M, Harousseau JL, Tournilhac O, Witz F, Berthou C, Escoffre-Barbe M, Guyotat D, Fegueux N, Himberlin C, Hunault M, Delain M, Lioure B, Jourdan E, Bauduer F, Dreyfus F, Cahn JY, Sotto JJ, Ifrah N. Addition of Androgens Improves Survival in Elderly Patients With Acute Myeloid Leukemia: A GOELAMS Study. J Clin Oncol. 2017 Feb;35(4):387-393. doi: 10.1200/JCO.2016.67.6213. Epub 2016 Oct 24. | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Completed | |||||||||
| Actual Enrollment ICMJE |
330 | |||||||||
| Original Actual Enrollment ICMJE | Same as current | |||||||||
| Actual Study Completion Date ICMJE | May 2008 | |||||||||
| Actual Primary Completion Date | April 2005 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 60 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | France | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00700544 | |||||||||
| Other Study ID Numbers ICMJE | LAM SA 2002 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Current Responsible Party | CHU Grenoble Pr Jean Jacques SOTTO, GOELAMS BGMT | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor ICMJE | University Hospital, Grenoble | |||||||||
| Original Study Sponsor ICMJE | Same as current | |||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University Hospital, Grenoble | |||||||||
| Verification Date | June 2008 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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