Treatment Outcome in Elderly Patients
This study has been completed.
Sponsor:
University Hospital, Grenoble
Collaborators:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
BGMT
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00700544
First received: June 13, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
AML Elderly Patients |
Drug: chemotherapy treatment (see arm) + norethandrolone Drug: chemotherapy treatment (see arms) |
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: | Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Grenoble:
Primary Outcome Measures:
- The primary objective of this study was to assess the ability of androgens to increase DFS. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 330 |
| Study Start Date: | June 2002 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Active Comparator: B
|
Drug: chemotherapy treatment (see arms)
Induction chemotherapy + maintenance chemotherapy
Other Name: Induction chemotherapy + maintenance chemotherapy
|
Experimental: A
|
Drug: chemotherapy treatment (see arm) + norethandrolone
oral form Dosage: 10 mg in patients with a weight < 60 kgs 20 mg in patients with a weight > 60 kgs frequency: every day Duration: 2 years Other Name: norethandrolone = nilevar®
|
Detailed Description:
Induction Therapy:
- Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1
- if CR or PR: randomisation = maintenance therapy including or not androgens
Maintenance therapy :
- 6 courses of reinduction with idarubicin (8mg/m2 d1) and cytarabine (100mg/m2d1-5, subcutaneously) every 3 months, and, between these courses, a continuous regimen of methotrexate and 6-mercaptopurine.
- Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients aged 60 years or more
- "de novo" AML according to FAB criteria
- AML with 20% or more myeloid marrow blasts
- signed and dated informed consent
- OMS score < 3
- Life expectancy > 1 month
Exclusion Criteria:
- Patients aged < 60 years
- or AML M3
- or not classificated according to FAB criteria
- or extramedular localisation of AML
- OMS score ≥ 3
- clinical Abnormal Cardiac fonction or with left ejection fraction < 40 %
- abnormal renal function with creatinine clearance < 50/ml/mn/m²
- abnormal hepatic function
- previous cerebral stroke
- previous malignancy : prostate, breast cancer (males)
- PSA dosage > 4
- Any coexisting medical or psychological condition that would pleclude participation in the required study procedures
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00700544
Locations
| France | |
| Arnaud PIGNEUX | |
| Pessac, France, 33604 | |
Sponsors and Collaborators
University Hospital, Grenoble
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
BGMT
Investigators
| Principal Investigator: | Jean jacques SOTTO, MD | GOELAMS/BGMT |
| Principal Investigator: | Arnaud PIGNEUX, MS | GOELAMS/BGMT |
| Principal Investigator: | Francis WITZ, MS | Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
More Information
Additional Information:
No publications provided
| Responsible Party: | CHU Grenoble Pr Jean Jacques SOTTO, GOELAMS BGMT |
| ClinicalTrials.gov Identifier: | NCT00700544 History of Changes |
| Other Study ID Numbers: | LAM SA 2002 |
| Study First Received: | June 13, 2008 |
| Last Updated: | June 13, 2008 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Grenoble:
|
AML elderly patients Treatment outcome |
Additional relevant MeSH terms:
|
Norethandrolone Anabolic Agents Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013