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Fludarabine and Cytarabine as Continuous Infusion Plus G-CSF Priming for Elderly Patients With Resistant AML

NCT ID: NCT00529880

Last Updated: 2007-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2007-10-31

Brief Summary

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* 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.

Detailed Description

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* A second course of induction chemotherapy can be given to the patient when a partial remission but less than a complete remission is achieved after the first course. At least 4 weeks should be apart between start of the first course and start of the second course.
* G-CSF (Lenograstim) 250 g/day will begin to be administered after the confirmation of hypocellular bone marrow with blasts less than 5% on day 14 or later until absolute neutrophil counts are 1,000/l or more.
* For the patients who achieve a complete remission, consolidation therapy will be given as follows:

* Two more cycles of the same chemotherapy will be given to the patients who achieve a complete remission after single induction course. Allogeneic or autologous hematopoietic cell transplantation could be also considered.
* In patients who relapse after allogeneic hematopoietic cell transplantation, donor leukocyte infusion will be done without consolidation chemotherapy.
* In patients who had extramedullary relapse(s), local radiotherapy can be given to the relapse site(s).

Conditions

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Acute Myeloid Leukemia

Keywords

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AML

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fludarabine , cytarabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Inadequate hepatic,renal,cardiac function
* Psychiatric disorder or mental deficiency
* CNS involvement of leukemic blasts
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cooperative Study Group A for Hematology

NETWORK

Sponsor Role lead

Principal Investigators

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Hawk Kim, professor

Role: PRINCIPAL_INVESTIGATOR

Ulsan University Hospital, ROK

Locations

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Asan Medical Center

Songpa-gu, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Keun-Hee Kim, nurse

Role: CONTACT

Phone: 82-2-3010-7290

Email: [email protected]

Facility Contacts

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Keun-Hee Kim, nurse

Role: primary

Other Identifiers

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C-008

Identifier Type: -

Identifier Source: org_study_id