Acute Myeloid Leukemia Clinical Trial
— LAM-RAPAOfficial title:
Rapamycin in Combination With Low-dose Aracytin in Elderly Acute Myeloid Leukemia Patients. A Study From the Groupe Ouest Est d'étude Des Leucémies Aiguës Myéloïdes (GOELAMS)
| Verified date | February 2024 |
| Source | University Hospital, Toulouse |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
These study is designed to evaluate the tolerability and efficacy of sirolimus (rapamycin) in combination with low-dose aracytin in elderly AML.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | June 2008 |
| Est. primary completion date | June 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | Inclusion Criteria: - Informed consent - de novo or secondary LAM (CML excluded) not elligible for intensive chemotherapy. - Previously untreated Exclusion Criteria: - Renal impairment (serum creatinin >2N) - Hepatic impairment (TGO ou TGP > 5N), une cholestase (Phosphatases Alcalines or gamma-GT > 5N),bilirubin > 3N - Blast crisis CML - Acute Promyelocytic Leukemia. |
| Country | Name | City | State |
|---|---|---|---|
| France | Service d'Hématologie, CHU | Angers | |
| France | Service d'Hématologie, Hôpital Jean Minjoz | BESANçON | |
| France | Service d'Hématologie CHU Purpan | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Toulouse | French Innovative Leukemia Organisation |
France,
Recher C, Beyne-Rauzy O, Demur C, Chicanne G, Dos Santos C, Mas VM, Benzaquen D, Laurent G, Huguet F, Payrastre B. Antileukemic activity of rapamycin in acute myeloid leukemia. Blood. 2005 Mar 15;105(6):2527-34. doi: 10.1182/blood-2004-06-2494. Epub 2004 Nov 18. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | response rate | |||
| Secondary | tolerability | |||
| Secondary | bioclinical markers of response |
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