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PRO#0118: Decitabine Plus Mini Flu-Bu

NCT01455506 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-02-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Michele Donato, MD · John Theurer Cancer Center at Hackensack University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455506 on ClinicalTrials.gov