Acute Myeloid Leukemia (AML) Clinical Trial
Official title:
A Pilot Study of Intravenous, Targeted-Dose Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation in High-Risk AML
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.
Status | Terminated |
Enrollment | 3 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 56 Years to 74 Years |
Eligibility |
Inclusion Criteria: - Patients must have had histologically confirmed diagnosis of AML, in 1st complete remission, by a pathologic review at the H. Lee Moffitt Cancer Center and Research Institute. Any induction/consolidation regimen is permitted. - General Inclusion Criteria: 1. Age 56-74 2. Able to give informed consent 3. Hepatic and renal function: normal bilirubin, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal 4. Left ventricular ejection fraction (LVEF) must be in normal range 5. FEV1 AND DLCO greater than or equal to 50% predicted (at planned time of transplantation) 6. ECOG PS less than or equal to 2 (at planned time of transplantation) - Disease Specific Inclusion Criteria: 1. Adverse-risk karyotype (del 5/5q, 7/7q, 3q, greater than or equal to 3 abnormalities): 2. Intermediate-risk karyotype [46 XY, +8, -Y, +6, or any other isolated (<3 total) non-random abnormality not included in the adverse-risk category or favorable-risk category below] - AML arising from antecedent hematologic disorder (e.g. MDS) - Secondary AML (t-AML) Exclusion Criteria: - Acute Promyelocytic Leukemia(FAB M3) subtype - Presence of (8;21) translocation or inversion 16/t(16;16) cytogenetic phenotype (i.e. favorable-risk AML) - Eligible for and willing to undergo matched-sibling allogeneic transplantation - Greater than 2 induction regimens required to achieve complete remission - Duration of > 8 weeks between completion of induction chemotherapy and initiation of consolidation chemotherapy - No prior malignancy is allowed, except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 5 years. - Prior extensive radiation therapy (>25% of bone marrow reserve) - Concomitant radiation therapy, chemotherapy, or immunotherapy - Intrinsic impaired organ function (as stated above) - Active infection - Positive serum pregnancy test in women who have not yet reached menopause (no menstrual periods for >12 months or who have not undergone tubal ligation or complete hysterectomy. - Women who are breast-feeding - Positive HIV testing - Presence of CNS leukemia - Uncontrolled insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal gland dysfunction - Physical or psychiatric conditions that in the estimation of the PI or his designee place the patient at high-risk of toxicity or non-compliance |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | ESP Pharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 100-day Non-relapse Mortality | 100-day non-relapse mortality is the number of participants who died before day 100 posttransplant from causes other than relapsed disease | 100 days post transplant | Yes |
Secondary | Successful Autologous Stem Cell Collection | Number of subjects who were able to collect at least 2 million CD34+ cells/kg | At time of stem cell collection | No |
Secondary | Severe Regimen-related Toxicity | Number of participants with severe regimen-related toxicity within 2 years posttransplant. Severe regimen-related toxicity was defined as CTC (version 3)grade 4. | up to 100 days post translant | Yes |
Secondary | 1 Year Event-free Survival | Number of participants alive and without disease relapse at 1 year posttransplant | 1 year post transplant | No |
Secondary | 1 Year Overall Survival | Number of participants alive at 1 year posttransplant | 1 year post transplant | No |
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