Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

All Drugs and Chemicals

Antineoplastic Agents

Lenograstim

Busulfan

Alkylating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion

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.

G-CSF

Leukapheresis

Busulfan IV daily x 4 days (transplantation days -5,-4,-3,-2). The day -5 and -4 dose will be 130mg/m2

Stem cell reinfusion

Jeffrey E Lancet, MD

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.

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

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

100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease

Number of subjects who were able to collect at least 2 million CD34+ cells/kg

Number of participants with severe regimen-related toxicity within 2 years posttransplant. Severe regimen-related toxicity was defined as CTC (version 3)grade 4.

Number of participants alive and without disease relapse at 1 year posttransplant

Number of participants alive at 1 year posttransplant

ESP Pharma

H. Lee Moffitt Cancer Center and Research Institute

Autologous Hematopoietic Progenitor Cell Transplantation

Age, Continuous

Between 18 and 65 years

>=65 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Two patients enrolled and transplanted out of 24 targeted transplant accrual goal. Due to poor enrollment study closed and no further analyses were conducted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation	NCT00363467	Acute Myeloid L...	G-CSF Leukapheresis Busulfan Stem cell reinf...	56 Years - 74 Years	H. Lee Moffitt Cancer Center and Research Institute
Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation	NCT00363467	Acute Myeloid L...	G-CSF Leukapheresis Busulfan Stem cell reinf...	56 Years - 74 Years	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for autologous stem cells