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PRO#0118: Decitabine Plus Mini Flu-Bu

This study is currently recruiting participants.
Verified May 2013 by Hackensack University Medical Center
Sponsor:
Information provided by (Responsible Party):
Hackensack University Medical Center
ClinicalTrials.gov Identifier:
NCT01455506
First received: June 2, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  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:

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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Estimated 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

Ages Eligible for Study:   45 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455506

Contacts
Contact: Emily Brown, RN 551-996-3923 EmilyBrown@hackensackUMC.org
Contact: Ann Marie Maguire, RN 551-336-8213 AMaguire@hackensackUMC.org

Locations
United States, New Jersey
Hackensack University Medical Center - John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Emily Brown, RN     551-996-3923     EmilyBrown@hackensackUMC.org    
Contact: Ann Marie Maguire, RN     551-336-8213     AMaguire@hackensackUMC.org    
Principal Investigator: Michele Donato, MD            
Sponsors and Collaborators
Hackensack University Medical Center
Investigators
Principal Investigator: Michele Donato, MD John Theurer Cancer Center at Hackensack University Medical Center
  More Information

No publications provided

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: May 9, 2013
Health Authority: United States: Institutional Review Board

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
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Busulfan
Fludarabine monophosphate
Decitabine
Fludarabine
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013