Clinical trial NCT00700544: Treatment Outcome in Elderly Patients
Official title: Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: AML
Elderly Patients
Keywords: AML
elderly patients
Treatment outcome
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: French Innovative Leukemia Organisation
name: BGMT
First posted: 2008-06-18
Enrollment: 330
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: * 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 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

Primary outcomes:
measure: The primary objective of this study was to assess the ability of androgens to increase DFS.
timeFrame: 3 years
Secondary outcomes:
measure: The secondary objective was to improved EFS and OS and to assess side effects and toxicity of androgenotherapy
timeFrame: 3 years
Other outcomes:
Locations:
city: Pessac
country: France
facility: Arnaud PIGNEUX
Study officials:
affiliation: GOELAMS/BGMT
name: Jean jacques SOTTO, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: GOELAMS/BGMT
name: Arnaud PIGNEUX, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: French Innovative Leukemia Organisation
name: Francis WITZ, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.