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

NCT ID: NCT00820976

Last Updated: 2009-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-03-31
• Study Completion Date: 2009-01-31

Brief 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.

Conditions

AML

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control

remission induction with cytosine arabinoside amd idarubicine

Group Type: NO_INTERVENTION

No interventions assigned to this group

G-CSF

G-CSF was administered starting on Day 8 until neutrophil recovery

Group Type: EXPERIMENTAL

G-CSF

Intervention Type: DRUG

Filgrastim(5 µg/kg intravenously over 30 minutes ) was administered starting from day 8 until neutrophil recovery

Interventions

G-CSF

Filgrastim(5 µg/kg intravenously over 30 minutes ) was administered starting from day 8 until neutrophil recovery

Intervention Type: DRUG

Other Intervention Names

Neupogen

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turkish Leukemia Study Group

OTHER

Sponsor Role: lead

Responsible Party

Turkish Leukemia Sutdy Group

References

Beksac M, Ali R, Ozcelik T, Ozcan M, Ozcebe O, Bayik M, Paydas S, Buyukasik Y, Ilhan O, Ozkalemkas F, Gurman G, Uysal A, Akan H, Soydan EA, Tunali A. Short and long term effects of granulocyte colony-stimulating factor during induction therapy in acute myeloid leukemia patients younger than 65: results of a randomized multicenter phase III trial. Leuk Res. 2011 Mar;35(3):340-5. doi: 10.1016/j.leukres.2010.07.005. Epub 2010 Jul 29.

Reference Type: DERIVED

PMID: 20673585 (View on PubMed)

Other Identifiers

TLG-AML-95-002

Identifier Type: -

Identifier Source: org_study_id