PRO#0118: Decitabine Plus Mini Flu-Bu - Full Text View

Purpose

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	Intervention	Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome	Drug: Decitabine plus Fludarabine and Busulfan	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: core binding factor acute myeloid leukemia cytogenetically normal acute myeloid leukemia familial acute myeloid leukemia with mutated CEBPA

Drug Information available for: Busulfan Decitabine Fludarabine Fludarabine phosphate

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by Hackensack University Medical Center:

Primary Outcome Measures:

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.


Enrollment:	20
Study Start Date:	May 2009
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455506

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


Responsible Party:	Hackensack University Medical Center
ClinicalTrials.gov Identifier:	NCT01455506 History of Changes
Other Study ID Numbers:	Decitabine plus mini-FluBu
Study First Received:	June 2, 2011
Last Updated:	February 1, 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 Azacitidine Busulfan	Vidarabine Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Alkylating Agents Antineoplastic Agents, Alkylating Myeloablative Agonists

ClinicalTrials.gov processed this record on June 26, 2017