Clinical trial · Interventional
Treatment Outcome in Elderly Patients
Adjonction of Androgenotheapy for Post-Remission Treatment of Elderly Patients With Acute Myeloid Leukemia - Results of the Multicenter Goelams SA-2002 Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Elderly Patients | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy treatment (see arm) + norethandrolone | Drug | — | UNRESOLVED |
| chemotherapy treatment (see arms) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- * Induction therapy Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1) If CR ou PR * maintenance therapy every 3 months = 6 courses of reinduction with : -idarubicin (8mg/m2 d1),cytarabine (100mg/m2d1-5 ), subcutaneously * between the courses, a continuous regimen of methotrexate and 6-mercaptopurine.
- interventionNames
- Drug: chemotherapy treatment (see arms)
- type
- EXPERIMENTAL
- label
- A
- description
- * Induction therapy Idarubicin, 8mg/m2 d1-5; Cytarabine, 100mg/m2 d1-7 and Lomustine, 200mg/m d1) If CR ou PR * maintenance therapy every 3 months = 6 courses of reinduction with : * idarubicin (8mg/m2 d1),cytarabine (100mg/m2d1-5, subcutaneously) * 10 to 20 mg (according to body weigh) of norethandrolone daily * between the courses, a continuous regimen of methotrexate and 6-mercaptopurine.
- interventionNames
- Drug: chemotherapy treatment (see arm) + norethandrolone
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDPigneux 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. PMID 28129526