Trials / Completed

CompletedNCT01707004

Decitabine and Total-Body Irradiation Followed By Donor Bone Marrow Transplant and Cyclophosphamide in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

Decitabine Followed by Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Neoplasms

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 20 (actual)

Sponsor: University of Wisconsin, Madison · Academic / Other
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

This phase II trial studies how well decitabine and total-body irradiation followed by donor bone marrow transplant and cyclophosphamide works in treating patients with relapsed or refractory acute myeloid leukemia. Giving decitabine and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving decitabine and total-body irradiation before the transplant together with high-dose cyclophosphamide, tacrolimus, and mycophenolate mofetil after the transplant may stop this from happening.

Detailed description

PRIMARY OBJECTIVES: I. To determine overall survival at 100 days after transplantation following decitabine and a bone marrow transplant using a donor that is at least partially-matched and a myeloablative preparative regimen with post-transplantation cyclophosphamide for graft-versus-host disease (GVHD) prophylaxis. SECONDARY OBJECTIVES: I. Patients enrolled in this study will also be followed for the following endpoints: neutrophil and platelet recovery, graft failure, acute graft-versus-host disease (GVHD), chronic GVHD, incidence of infection, treatment-related mortality, time to relapse/progression, overall survival, and progression-free survival. OUTLINE: Beginning between days -29 and -22, patients receive decitabine intravenously (IV) over 1 hour daily for 10 days, fludarabine phosphate IV over 30 minutes on days -5 to -2, and busulfan IV over 3 hours on days -5 to -2. PREPARATIVE REGIMEN: Patients undergo total-body irradiation twice daily (BID) on day -1. TRANSPLANT: Patients undergo allogeneic bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 2 hours on days 3 and 4, tacrolimus orally (PO) BID or IV continuously on days 5-180, mycophenolate mofetil PO three times daily (TID) on days 5-35 and filgrastim subcutaneously (SC) beginning day 5 until absolute neutrophil count (ANC) \>= 1,000/mm\^3 for 3 consecutive days. After completion of study treatment, patients are followed up at 6 months and 1 year.

Conditions

Interventions

Type	Name	Description
DRUG	decitabine	Given IV
DRUG	fludarabine phosphate	Given IV
DRUG	busulfan	Given IV
DRUG	cyclophosphamide	Given IV
DRUG	tacrolimus	Given PO or IV
DRUG	mycophenolate mofetil	Given PO
BIOLOGICAL	filgrastim	Given SC
RADIATION	total-body irradiation	Undergo total-body irradiation
PROCEDURE	allogeneic bone marrow transplantation	Undergo allogeneic bone marrow transplantation
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

Start date: 2013-05-16
Primary completion: 2017-07-22
Completion: 2017-10-07
First posted: 2012-10-15
Last updated: 2019-11-21
Results posted: 2019-05-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01707004. Inclusion in this directory is not an endorsement.