NCT00925873

Brief Summary

In this study, patients were randomly assigned to either receive fludarabine or not (20 mg/m2/d) in addition to induction chemotherapy, consolidation chemotherapy and the 3 subsequent re-induction courses during maintenance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 1996

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

Enrollment Period

3.8 years

First QC Date

March 31, 2009

Last Update Submit

June 19, 2009

Conditions

Acute Myeloid Leukemia

Keywords

FludarabineAMLelderly patients

Outcome Measures

Primary Outcomes (1)

  • Event-free survival (EFS)

    long term results (median follow up: 71 months)

Secondary Outcomes (1)

  • evaluation of the CR rate, remission duration disease-free survival (DFS) overall survival (OS),

    long term results (median follow up: 71 months)

Study Arms (2)

1

ACTIVE COMPARATOR

Control arm without fludarabine 1. Induction course: Ara-C 100mg/m2 days 1-7, idarubicin 8mg/m2 days 1-5, GM-CSF (molgramostim, Novartis) 5 microg/kg days 1 to neutrophil recovery; 2. Consolidation course: Ara-C 1g/m2 q12h days 1-3, idarubicin 10mg/m2 days 2-3; 3. and 3 quarterly reinduction courses during maintenance including Ara-C 80mg/m2 days 1-5, CCNU 40mg and mitoguazone 350mg/m2 day 1, ± fludarabine days 1-2.

Drug: Active comparator (no fludarabine)

2

EXPERIMENTAL

Fludarabine arm The same regimen with fludarabine 20 mg/m2/day IV for 30 minutes 1. induction course + fludarabine days 2-7; 2. consolidation course + fludarabine days 4-5; 3. during reinduction courses + fludarabine days 1-2.

Drug: Experimental (fludarabine)

Interventions

Active comparator (no fludarabine)DRUG

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)

Also known as: Arm A
1
Experimental (fludarabine)DRUG

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.

Also known as: Arm B
2

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients aged 60 to 75 years old
  • untreated de novo AML
  • performance status less than 2

You may not qualify if:

  • performance status more than 2
  • congestive heart failure or abnormal left ventricular ejection fraction
  • severe hepatic or renal disturbances
  • history of documented myelodysplastic or myeloproliferative syndrome
  • patients previously treated with chemotherapy or radiation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GOELAMS

Tours, 37000, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fludarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Francis WITZ, MD

    French Innovative Leukemia Organisation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2009

First Posted

June 22, 2009

Study Start

June 1, 1996

Primary Completion

April 1, 2000

Study Completion

November 1, 2004

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

FR(1)