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

This study has been completed.

Sponsor:

Information provided by:

Turkish Leukemia Study Group

ClinicalTrials.gov Identifier:

NCT00820976

First received: January 9, 2009

Last updated: NA

Last verified: January 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 9, 2009
Last Updated Date	January 9, 2009
Start Date ^ICMJE	March 1996
Primary Completion Date	March 2000 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 9, 2009)	response to induction [ Time Frame: 3 year ] [ Designated as safety issue: No ] overall survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Induction With or Without Granulocyte Colony-Stimulating Factor in AML Transplantation in AML
Official Title ^ICMJE	A Phase III, Randomized Multicenter Study of Induction With or Without Granulocyte Colony-Stimulating Factor in AML
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	AML
Intervention ^ICMJE	Drug: G-CSF Filgrastim(5 µg/kg intravenously over 30 minutes ) was administered starting from day 8 until neutrophil recovery Other Name: Neupogen
Study Arm (s)	No Intervention: control remission induction with cytosine arabinoside amd idarubicine Experimental: G-CSF G-CSF was administered starting on Day 8 until neutrophil recovery Intervention: Drug: G-CSF
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	260
Completion Date	January 2009
Primary Completion Date	March 2000 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	16 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00820976
Other Study ID Numbers ^ICMJE	TLG-AML-95-002
Has Data Monitoring Committee	Yes
Responsible Party	Meral Beksac MD, principal investigator, Turkish Leukemia Sutdy Group
Study Sponsor ^ICMJE	Turkish Leukemia Study Group
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Turkish Leukemia Study Group
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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