PRO#0118: Decitabine Plus Mini Flu-Bu

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a single institution study of combining decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation. A study population of 20 subjects will be enrolled from The John Theurer Cancer Center at Hackensack University Medical Center. Subjects who are eligible to receive allogeneic hematopoietic stem cell transplantation according to the eligibility criteria will be consented and enrolled. Subjects will receive treatment with decitabine followed by reduced intensity fludarabine and busulfan prior to allogeneic stem cell transplantation. Subjects will be followed until 1 year post transplantation to assess stability of engraftment, toxicity, progression free survival, and disease response

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hackensack Meridian Health; Hackensack University Medical Center
• Treatments: Azacitidine; Busulfan; Decitabine; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

Inclusion Criteria:

• Diagnosis of acute myelogenous leukemia or myelodysplastic syndrome being considered for transplantation.

• Age 45 to 80 years or < 45 with co-morbidity including: disease not in remission

• No uncontrolled infections.

• Patients shall have a 6/6 HLA-compatible related donor or an 8/8 -HLA-compatible unrelated donor.

• KPS 70-100%

• Creatinine < 1.6 X ULN (unless age < 45 yrs)

• Serum Bilirubin < 2.5 X ULN

• Capable of giving informed consent and have signed the informed consent form.

• Cardiac EF > 50% or cardiac clearance

• Pulmonary DLCO > 50% or pulmonary clearance

Exclusion Criteria:

• Untreated CNS leukemia

• Active hepatitis or other untreated infections