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PRO#0118: Decitabine Plus Mini Flu-Bu

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455506
First Posted: October 20, 2011
Last Update Posted: February 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hackensack University Medical Center
  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: 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

Resource links provided by NLM:


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.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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
First Submitted: June 2, 2011
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