Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

Stopped early · Not applicable

Conditions studied: Acute Myeloid Leukemia (AML)

In brief

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.

Key facts

Study ID

NCT00363467

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

3

Starts

2006-05-01

Expected to finish

2009-05-01

Last updated by the study team

2017-03-23

Who can join

Age: 56 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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 Inclusion Criteria:
• 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)

You may not qualify if…

• 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

Where it is running

• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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