Clinical trial NCT00363467
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Busulfan Acute myeloid leukemia (AML) Hematopoietic Stem Cell Transplantation (HSCT) Dendritic cells Bone marrow transplantation PBSC mobilization Autologous stem cells
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2006-05-01; Completion date: 2009-05-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
During the pre-transplantation phase (following completion of consolidation chemotherapy), patients will begin to receive G-CSF at 10 mcg/kg twice daily; leukapheresis will also be given until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. Conditioning/Preparative therapy will follow PBSC collection for up to 30 days with Busulfan IV daily x 4 days; subsequent doses will be adjusted based on pharmacokinetic (plasma level)monitoring. Following 1 day of rest, stem cell reinfusion will begin with supportive care. During follow-up, patients will be monitored out to 730 days.

Detailed description:
1. Pre- Transplantation Phase -

   1. Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously. Alternatively, patients may receive G-CSF alone (same dose) as mobilization therapy.
   2. Leukapheresis will begin day 4 of G-CSF administration and proceed according to institutional guidelines. Leukapheresis will continue until a target goal for recipient body weight is obtained, or up to a maximum of 5 days. A minimum recipient body weight is required to proceed to transplantation.
2. Transplantation Phase

   a. Conditioning/Preparative therapy - up to 30 days following PBSC collection, patients will begin conditioning therapy with Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2; subsequent doses will be adjusted based on pharmacokinetic monitoring.
   * Busulfan plasma level monitoring, collected around the first dose of busulfan b. Stem cell reinfusion - following 1 day of rest, previously collected autologous peripheral blood stem cells will be infused.
   * The administration of supportive measures (e.g. intravenous fluids, antihistamines) during stem cell reinfusion will be performed according to institutional guidelines.
3. Supportive care

   1. Antibiotic prophylaxis- according to hospital/institutional guidelines, and at the discretion of the treating physician.
   2. Growth factor support
   3. Transfusion support
   4. Prophylaxis for busulfan-induced seizures
4. During follow-up, patients will be seen at least weekly for the first month and there after periodically out to 730 days posttransplant. The following medical procedures will be done:

   * Medical history and physical exam (including concurrent meds, vital signs, performance status and weight)
   * Standard labs
   * Bone marrow aspirate and biopsy

Arms: arm 1: G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
Interventions: intervention 1: G-CSF intervention 2: Leukapheresis intervention 3: Busulfan intervention 4: Stem cell reinfusion
Intervention descriptions: intervention 1: Mobilization Option 1:Twenty-four to 48 hours following completion of consolidation chemotherapy, patients will begin to receive G-CSF at 10 mcg/kg twice daily subcutaneously.

Mobilization Option 2: If patients have recovered hematologically from consolidation chemotherapy, they may receive G-CSF at 10 mcg/kg twice daily subcutaneously. intervention 2: leukapheresis intervention 3: Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2 intervention 4: autologous stem cell transplant

Protocol documents: