FLAG+Ida With G-CSF Priming for Patients Younger Than 60... | NCT00559221

Studies
FLAG+Ida With G-CSF Priming for Patients Younger Than 60 Years With Resistant AML

NCT00559221

Sponsor

Cooperative Study Group A for Hematology

Status

Unknown status

Last Update Posted

Oct 15, 2008Estimated

Enrollment

37Estimated

Phase

Phase 2

Conditions

Acute Myeloid Leukemia

Interventions

FLAG+IDA

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Jun 2008Estimated

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2008

Last Update Posted Date

Oct 15, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

- To determine the feasibility of fludarabine and cytarabine as continuous infusion plus idarubicin with granulocyte-colony stimulating factor priming for patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia

Detailed Description

- The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Label	Type	Description	Intervention Names
1	No Intervention		Drug: FLAG+IDA

Name	Type	Description	Arm Group Labels	Other Names
FLAG+IDA	Drug	Fludarabine, cytarabine, G-CSF	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complete remission rate, duration of complete remission, toxicities		06/2008

Secondary Outcomes

Measure	Description	Time Frame
progression-free survival, overall survival		06/2008

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Failure to achieve CR after initial induction chemotherapy including standard dose cytarabine.
Early relapse, occurring after a first CR lasting less than 12 months.
Patients with multiple relapses will be included.
Written informed consent must be given.
15 and 60 years of age.
2 or less by ECOG performance scale.

Exclusion Criteria:

acute promyelocytic leukemia
pregnant or lactating

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yae-Eun Jang, nurse	Contact	80-2-3010-7290		redpin75@paran.com

Overall Officials

Name	Affiliation	Role
Hawk Kim, professor	Ulsan Universtity Hospital, ROK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center	Recruiting	Seoul		138-736	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25891993	Derived	Kim H, Lee JH, Joo YD, Bae SH, Lee JH, Kim DY, Lee WS, Ryoo HM, Jo JC, Choi Y, Lee KH; CoOperative Study Group A for Hematology (COSAH). A prospective, multicenter phase II study of continuous infusion of FLAG for patients older than 60 yr with resistant acute myeloid leukemia: a comparison with intensive younger patients' trial. Eur J Haematol. 2016 Feb;96(2):188-97. doi: 10.1111/ejh.12568. Epub 2015 May 6.

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms