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Decitabine Followed by Partially Matched Related Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia.


Phase 2
18 Years
60 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia

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Trial Information

Decitabine Followed by Partially Matched Related Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia.


This study is a Phase II study of decitabine followed by myeloablative conditioning,
transplantation of partially HLA-mismatched bone marrow and post-transplantation
cyclophosphamide in patients with acute myelogenous leukemia, and high-risk myelodysplastic
syndrome.


Inclusion Criteria:



- Acute myelogenous leukemia

- Myelodysplastic syndromes

- Available related donor that is at least a high resolution (allele level) haplotype
match at HLA A, B, C, DRB1 and DQB1.

Exclusion Criteria:

- Active CNS leukemia within two weeks of registration

- New or active infection

- Active HIV, hepatitis A, B or C infection

- Allergy or hypersensitivity to agents used within the treatment protocol.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Description:

The primary objective is to determine overall survival at 100 days after transplantation following decitabine and a HLA-haploidentical bone marrow transplantation using a myeloablative preparative regimen and post-transplantation cyclophosphamide.

Outcome Time Frame:

100 days

Safety Issue:

Yes

Principal Investigator

Mark B Juckett, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

HO11421

NCT ID:

NCT01707004

Start Date:

July 2012

Completion Date:

July 2016

Related Keywords:

  • Acute Myeloid Leukemia
  • Relapsed
  • Refractory
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location
University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001