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Induction With or Without Granulocyte Colony-Stimulating Factor in AML Transplantation in AML (TLG-AML-95-002)

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ClinicalTrials.gov Identifier: NCT00820976
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : January 12, 2009
Sponsor:
Information provided by:
Turkish Leukemia Study Group

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.


Condition or disease Intervention/treatment Phase
AML Drug: G-CSF Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized Multicenter Study of Induction With or Without Granulocyte Colony-Stimulating Factor in AML
Study Start Date : March 1996
Actual Primary Completion Date : March 2000
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: control
remission induction with cytosine arabinoside amd idarubicine
Experimental: G-CSF
G-CSF was administered starting on Day 8 until neutrophil recovery
Drug: G-CSF
Filgrastim(5 µg/kg intravenously over 30 minutes ) was administered starting from day 8 until neutrophil recovery
Other Name: Neupogen




Primary Outcome Measures :
  1. response to induction [ Time Frame: 3 year ]
  2. overall survival [ Time Frame: 3 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Meral Beksac MD, principal investigator, Turkish Leukemia Sutdy Group
ClinicalTrials.gov Identifier: NCT00820976    
Other Study ID Numbers: TLG-AML-95-002
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009
Keywords provided by Turkish Leukemia Study Group:
G-CSF
AML
survival