NCT00189488 - Trial to Evaluate Palifermin in the Reduction of Acute Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Allogeneic Marrow/Peripheral Blood Progenitor Cell (PBPC) Transplantation | Biotech Hunter

Enrollment

155

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

November 30, 2008

Study Completion Date

August 31, 2013

Conditions

Graft Versus Host DiseaseHematologic Malignancies

Interventions

DRUG

Palifermin

Administered as an intravenous (IV) bolus.

DRUG

Placebo

Administered as an intravenous (IV) bolus.

OTHER

Conditioning Regimen

"Each participant received 1 of the following conditioning regimens:~* Cyclophosphamide (Cy) / total body irradiation (TBI) with and without etoposide (VP-16)~* TBI/VP-16~* Melphalan (Mel)/TBI (TBI regimens must include fully ablative doses ie \> 1100 cGy; sequence of chemotherapy/radiation (CT/RT) flexible)~* Busulfan (Bu)/Cy~* Bu/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\])~* Fludarabine (Flu)/Mel (non-TBI but fully ablative regimens/doses \[Mel dose \> 140 mg/m\^2\])"

PROCEDURE

Allogeneic stem cell transplant

Allogeneic marrow/peripheral blood progenitor cell transplantation

DRUG

Methotrexate