NCT00363467

Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

A Pilot Study of Intravenous, Targeted-Dose Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation in High-Risk AML

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 56 Years – 74 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	G-CSF	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.
DRUG	Leukapheresis	leukapheresis
DRUG	Busulfan	Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2
PROCEDURE	Stem cell reinfusion	autologous stem cell transplant

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2006-08-15
• Last updated: 2017-03-23
• Results posted: 2011-09-30

Locations

1 site across 1 country: United States