PRO#0118: Decitabine Plus Mini Flu-Bu

Study Description

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Brief 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

Condition or disease	Intervention/treatment	Phase
Acute Myeloid Leukemia; Myelodysplastic Syndrome	Drug: Decitabine plus Fludarabine and Busulfan	Phase 1

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	PRO#0118: A Phase I Study of Decitabin in Combination With Fludarabin and Busulfan as a Reduced Intensity Conditioning Regimen for the Treatment of Myeloid Malignancies
Study Start Date :	May 2009
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Arms and Interventions

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Arm

Intervention/treatment

Experimental: Decitabine with fludarabine and busulfan; decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation

Drug: Decitabine plus Fludarabine and Busulfan; Decitabine will be administered at a dose of 60 mg/m2 IV daily based on adjusted body weight for patient >20% above ideal body weight; Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 5 days starting on transplant day -7.; Busulfan will be administered at a dose of 130 mg/m2 IV daily for 2 days on transplant days -4 and -3. Patients will also receive rabbit antithymocyte globulin (Thymoglobulin) at a dose of 2 mg/kg IV daily for 3 days on transplant days -4, -3, and -2. Hematopoietic cells will be infused on day 0.

Outcome Measures

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Primary Outcome Measures :

1. To assess the effect of decitabine in combination with fludarabine and busulfan prior to allogeneic stem cell transplantation on the rate of primary graft rejection [ Time Frame: up to 1 year post transplantation ]
   Graft failure defined by the presence of <10% donor lymphoid cells on peripheral blood analysis performed on post transplant day 84(+/- 10 days) in patients who have not relapsed will be measured.

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New Jersey
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601

Sponsors and Collaborators

Hackensack University Medical Center

Investigators

Principal Investigator:	Michele Donato, MD	John Theurer Cancer Center at Hackensack University Medical Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Hackensack University Medical Center
ClinicalTrials.gov Identifier:	NCT01455506 History of Changes
Other Study ID Numbers:	Decitabine plus mini-FluBu
First Posted:	October 20, 2011
Last Update Posted:	February 4, 2014
Last Verified:	February 2014

Keywords provided by Hackensack University Medical Center:

Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS); Bone Marrow Transplant; Stem Cell Transplant

Additional relevant MeSH terms:

Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Preleukemia; Leukemia; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Fludarabine; Fludarabine phosphate; Decitabine; Busulfan; Azacitidine	Vidarabine; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Antiviral Agents; Anti-Infective Agents; Alkylating Agents; Antineoplastic Agents, Alkylating; Myeloablative Agonists; Enzyme Inhibitors