Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation

• Status: Terminated
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: ESP Pharma
• Treatments: Busulfan

Criteria

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