Status:
TERMINATED
Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
ESP Pharma
Conditions:
Acute Myeloid Leukemia (AML)
Eligibility:
All Genders
56-74 years
Phase:
NA
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 targe...
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. Alterna...
Eligibility Criteria
Inclusion
- 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
- Age 56-74
- Able to give informed consent
- 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
- Left ventricular ejection fraction (LVEF) must be in normal range
- FEV1 AND DLCO greater than or equal to 50% predicted (at planned time of transplantation)
- ECOG PS less than or equal to 2 (at planned time of transplantation)
- Disease Specific
- Adverse-risk karyotype (del 5/5q, 7/7q, 3q, greater than or equal to 3 abnormalities):
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00363467
Start Date
May 1 2006
End Date
May 1 2009
Last Update
March 23 2017
Active Locations (1)
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1
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612