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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00815568
Other study ID # 2008-07-020
Secondary ID
Status Recruiting
Phase Phase 2
First received December 29, 2008
Last updated December 29, 2008
Start date August 2008
Est. completion date December 2012

Study information

Verified date December 2008
Source Samsung Medical Center
Contact Dong Hwan Kim
Phone +82-2-3410-1768
Email drkiim@medimail.co.kr
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 114
Est. completion date December 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 65 Years
Eligibility 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:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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)

Locations

Country Name City State
Korea, Republic of Dong Hwan Kim Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary progression free survival one year No
Secondary relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD one year No
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