GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly

PHASE3CompletedINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

June 30, 1996

Primary Completion Date

April 30, 2000

Study Completion Date

November 30, 2004

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Active comparator (no fludarabine)

"1. Ara-C (100 mg/m2/d by continuous IV infusion 7 days), idarubicin (8 mg/m2/d (IV) for 5 days), GM-CSF a dose of 5 mg/kg/d on day 1. (Novartis Laboratory, Rueil-Malmaison, France).~2. The consolidation course: intermediate-dose Ara-C (1g/m2 g 3-hour infusion twice a day 1 through 3) and idarubicin (10 mg/m2 on days 4 through 5). In the allocated arm~3. Maintenance therapy for one year with 6-thioguanine (100 mg/m2/d orally on days 1 through 4 every week, Ara-C (60 mg/m2 SC on day 5 weekly) interrupted every 3 months with a reinduction course including CCNU (40 mg orally on day 1), mitoguazone (350 mg/m2 on day 1) and Ara-C (40 mg/m2 sc twice daily day 1 to 5)"

DRUG

Experimental (fludarabine)

"The same regimen with addition of fludarabine in every treatment sequence~1. Induction course: Fludarabine (20 mg/m2/d, IV for 30 minutes) was started in the assigned group on day 2 and continued until the end of cytarabine treatment on day 7.~2. Consolidation course: In the allocated arm, fludarabine (20 mg/m2/d, IV) was administered on days 2 through 3, 4 hours prior to cytarabine infusion.~3. Reinduction courses: Ara-C associated in the allocated group with fludarabine (20 mg/m2/d, IV) on days 1 through 2."

Trial Locations (1)

37000

GOELAMS, Tours

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Schering SA

UNKNOWN

collaborator

Novartis

INDUSTRY

lead

French Innovative Leukemia Organisation

OTHER

NCT00925873 - GOELAMS SA4 Study: the Role of Fludarabine in the Treatment of Acute Myeloid Leukemia in the Elderly | Biotech Hunter | Biotech Hunter