Induction With or Without Granulocyte Colony-Stimulating Factor in AML Transplantation in AML

AML Clinical Trial

— TLG-AML-95-002  

Official title:

A Phase III, Randomized Multicenter Study of Induction With or Without Granulocyte Colony-Stimulating Factor in AML

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820976
• Other study ID #: TLG-AML-95-002
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2009
• Last updated: January 9, 2009
• Start date: March 1996
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Turkish Leukemia Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Background The effects of granulocyte colony-stimulating factors (G-CSF) on recovery following induction chemotherapy are widely accepted. However, their impact on response and survival has not been clarified yet. Male gender has been claimed to be a susceptibility factor for development of leukemia and shorten survival but effect of sex has not been analyzed in clinical trials utilizing G-CSF.

Design and Methods Efficacy and safety of G-CSF as an adjunct to de novo AML remission induction therapy was assessed in this prospective randomized Phase III multicenter trial. Patients were randomized to receive induction therapy consisting of either cytosine arabinoside 100mg/m2/d, days 1-10 and idarubicin 12 mg/m2/d, days 1-3 (control arm) or plus G-CSF (Filgrastim, 5 µg/kg/d starting from day 8 until absolute neutrophil count (ANC) over 0.5x109/L for two consecutive days) for a median duration of 14 days (G-CSF arm).

After achievement of CR, all patients received first consolidation course of Ara-C 1 gr/sq.m/d (d1-5) and Ida 12 mg/sq.m/d (d1-3). If patients did not have an HLA identical donor they were randomized to receive second course of consolidation either high dose Ara-C 3 gr/sq.m/d (d1, 3, 5) or G-CSF for collection of stem cells for the consecutive PBSCT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2009
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed AML

• Age over 16

• Performance status greater than 60

• Previously untreated

• Peripheral blood white blood cell (WBC) count of less than (<) 0.5 x109/L, and/or marrow leukemic blasts< 20 % at 7th day of remission induction treatment

Exclusion Criteria:

• Previously treated

• Acute promyelocytic leukemia

• Age equal or younger than 15

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML

Intervention

Drug:
• G-CSF
Filgrastim(5 µg/kg intravenously over 30 minutes ) was administered starting from day 8 until neutrophil recovery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Turkish Leukemia Study Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to induction		3 year	No
Primary	overall survival		3 year	No