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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)

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: AML; MDS; ALL; CML; Lymphoma

Intervention: fludarabine phosphate, busulfan (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Dong Hwan Kim, Study Director, Affiliation: Samsung Medical Center

Overall contact:
Dong Hwan Kim, Phone: +82-2-3410-1768, Email: drkiim@medimail.co.kr

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.

Clinical Details

Official title: Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies

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

Primary outcome: progression free survival

Secondary outcome: relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD

Detailed 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.

Eligibility

Minimum age: 15 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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:

-

Locations and Contacts

Dong Hwan Kim, Phone: +82-2-3410-1768, Email: drkiim@medimail.co.kr

Dong Hwan Kim, Seoul 135-710, Korea, Republic of; Recruiting
Additional Information

Starting date: August 2008
Last updated: December 29, 2008

Page last updated: August 23, 2015

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