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Feasibility and Efficacy Study of Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation (HCT) With Fludarabine, Busulfan, and Total Body Irradiation (TBI)

NCT ID: NCT00815568

Last Updated: 2008-12-30

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

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.

Detailed Description

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Conventional allogeneic hematopoietic cell transplantation (HCT) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclophosphamide (CY) plus 1200 or 1000 cGy total body irradiation (TBI; CY/TBI) or busulfan (Bu) / CY (BuCy). Unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients.

Recently, Fludarabine plus 4 day dose of busulfan (FluBu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (TRM). To improve transplant outcomes without increasing the risk of recurrence, Russell et al introduced 400cGy of TBI with antithymocyte (ATG, 4.5mg/Kg) into FluBu4 regimen with successful outcomes.

Conditions

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AML MDS ALL CML Lymphoma

Keywords

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fludarabine busulfan total body irradiation conditioning regimen

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regimen

Conditioning regimen for AML with FLT3 mutation, AML/MDS unfavorable cytogenetic risk group, chemorefractory NHL or HD, or ALL/CML

Group Type EXPERIMENTAL

fludarabine phosphate, busulfan

Intervention Type DRUG

Fludarabine ( 30mg/m2, iv, D-7\~D-2) Busulfan (3.2mg/kg, iv, D-6\~D-3) Total body irradiation (200cGy/day, D-2,-1)

Interventions

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fludarabine phosphate, busulfan

Fludarabine ( 30mg/m2, iv, D-7\~D-2) Busulfan (3.2mg/kg, iv, D-6\~D-3) Total body irradiation (200cGy/day, D-2,-1)

Intervention Type DRUG

Other Intervention Names

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Fludarabine (Fludara®, Berlex Laboratories, Richmond, CA)

Eligibility Criteria

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Inclusion Criteria

* At least 15 years old and not more than 65 years old.
* ECOG performance status 0-2.
* Patients with AML or MDS with intermediate/unfavorable cytogenetics.
* Patients with ALL and CML ineligible for Cy/TBI conditioning.
* Patients with NHL or HD eligible to myeloablative HCT.
* Patients receiving unrelated BMT for AML, MDS, ALL, CML, NHL or HD.
* Consent form signed and dated prior to study specific procedures.
* Subject able to comply with the scheduled follow-up and with the management of toxicities.

Exclusion Criteria

\-
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dept of Hematology/Medical Oncology, Samsung Medical Center

Principal Investigators

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Dong Hwan Kim

Role: STUDY_DIRECTOR

Samsung Medical Center

Locations

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Dong Hwan Kim

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong Hwan Kim

Role: CONTACT

Phone: +82-2-3410-1768

Email: [email protected]

Other Identifiers

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2008-07-020

Identifier Type: -

Identifier Source: org_study_id