PRO#0118: Decitabine Plus Mini Flu-Bu

NCT01455506 | Completed Phase 1 DMC

• 1 other identifier: Decitabine plus mini-FluBu
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (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

  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.

  up to 1 year post transplantation

Study Arms (1)

Decitabine with fludarabine and busulfan

EXPERIMENTAL

decitabine with fludarabine and busulfan in the setting of allogeneic stem cell transplantation

Drug: Decitabine plus Fludarabine and Busulfan

Interventions

Decitabine plus Fludarabine and Busulfan DRUG

* 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.

Decitabine with fludarabine and busulfan

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Untreated CNS leukemia
• Active hepatitis or other untreated infections

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack University Medical Center - John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Decitabine; fludarabine; Busulfan

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Michele Donato, MD

  John Theurer Cancer Center at Hackensack University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2011
• First Posted: October 20, 2011
• Study Start: May 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 4, 2014

Record last verified: 2014-02

Locations

US (1)