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


Phase 2
15 Years
65 Years
Open (Enrolling)
Both
AML, MDS, ALL, CML, Lymphoma

Thank you

Trial Information

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


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.


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:

-

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

progression free survival

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Dong Hwan Kim

Investigator Role:

Study Director

Investigator Affiliation:

Samsung Medical Center

Authority:

South Korea: Institutional Review Board

Study ID:

2008-07-020

NCT ID:

NCT00815568

Start Date:

August 2008

Completion Date:

December 2012

Related Keywords:

  • AML
  • MDS
  • ALL
  • CML
  • Lymphoma
  • fludarabine
  • busulfan
  • total body irradiation
  • conditioning regimen
  • Lymphoma

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