NCT00529880

Brief Summary

  • To determine the feasibility of fludarabine and cytarabine as continuous infusion plus granulocyte-colony stimulating factor priming for elderly patients with resistant acute myeloid leukemia other than acute promyelocytic leukemia
  • The feasibility will be evaluated in terms of toxicities, complete remission rate, duration of complete remission, disease-free survival, and overall survival.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2007

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

September 27, 2007

Status Verified

September 1, 2007

First QC Date

September 12, 2007

Last Update Submit

September 26, 2007

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (1)

  • Complete remission rate, duration of complete remission, toxicities

Secondary Outcomes (1)

  • progression-free survival, overall survival

Interventions

Fludarabine , cytarabineDRUG

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Failure to achieve CR after initial induction chemotherapy
  • Any relapse, regardless of the frequency and time of relapse from first CR
  • Relapse after hematopoietic cell transplantation, allogeneic or autologous.
  • Multiple relapses, extramedullary relapse(s)

You may not qualify if:

  • Inadequate hepatic,renal,cardiac function
  • Psychiatric disorder or mental deficiency
  • CNS involvement of leukemic blasts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Songpa-gu, Seoul, 138-833, South Korea

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fludarabineCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Hawk Kim, professor

    Ulsan University Hospital, ROK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keun-Hee Kim, nurse

CONTACT

82-2-3010-7290kuny9847@naver.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 12, 2007

First Posted

September 14, 2007

Study Start

December 1, 2004

Study Completion

October 1, 2007

Last Updated

September 27, 2007

Record last verified: 2007-09

Locations

KR(1)