PRO#0118: Decitabine Plus Mini Flu-Bu
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ClinicalTrials.gov Identifier: NCT01455506 |
Recruitment Status
:
Completed
First Posted
: October 20, 2011
Last Update Posted
: February 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myeloid Leukemia Myelodysplastic Syndrome | Drug: Decitabine plus Fludarabine and Busulfan | Phase 1 |

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 |

Arm | Intervention/treatment |
---|---|
Experimental: Decitabine with fludarabine and busulfan
decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation
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Drug: Decitabine plus Fludarabine and Busulfan
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. |
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01455506
United States, New Jersey | |
Hackensack University Medical Center - John Theurer Cancer Center | |
Hackensack, New Jersey, United States, 07601 |
Principal Investigator: | Michele Donato, MD | John Theurer Cancer Center at Hackensack University Medical Center |
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 Key Record Dates |
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 |