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

NCT00820976 | Completed Phase 3 DMC

• 1 other identifier: TLG-AML-95-002
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

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

Keywords

G-CSF; AML; survival

Outcome Measures

Primary Outcomes (2)

• response to induction

  3 year

• overall survival

  3 year

Study Arms (2)

control

NO INTERVENTION

remission induction with cytosine arabinoside amd idarubicine

G-CSF

EXPERIMENTAL

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

Drug: G-CSF

Interventions

G-CSF DRUG

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

Also known as: Neupogen

G-CSF

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previously treated
• Acute promyelocytic leukemia
• Age equal or younger than 15

Sponsors & Collaborators

• Turkish Leukemia Study Group: lead

Related Publications (1)

• 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.

  PMID: 20673585 DERIVED

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

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: January 9, 2009
• First Posted: January 12, 2009
• Study Start: March 1, 1996
• Primary Completion: March 1, 2000
• Study Completion: January 1, 2009
• Last Updated: January 12, 2009

Record last verified: 2009-01