Conditions: Graft Versus Host Disease Hematologic Malignancies
Keywords: Hematological Malignancies Graft-versus-host-disease Oral Mucositis Allogeneic Transplantation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 155
Healthy volunteers: no

Brief summary:
The main purpose of this study is to evaluate the effect of palifermin versus placebo in the reduction of severe acute graft versus host disease (GVHD) and severe oral mucositis.

Detailed description:

Arms:
arm 1: Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively. arm 2: Placebo to palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to palifermin 180 μg/kg once prior to transplant and at least 96 hours from previous placebo to palifermin 60 μg/kg dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m\^2 respectively.

Interventions: intervention 1: Palifermin intervention 2: Placebo intervention 3: Conditioning Regimen intervention 4: Allogeneic stem cell transplant intervention 5: Methotrexate
Intervention descriptions: intervention 1: Administered as an intravenous (IV) bolus. intervention 2: Administered as an intravenous (IV) bolus. intervention 3: 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 \[Mel dose \> 140 mg/m\^2\]) intervention 4: Allogeneic marrow/peripheral blood progenitor cell transplantation intervention 5: None

Protocol document: