Decitabine Followed by Partially Matched Related Bone Marrow Transplant for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia

This study is currently recruiting participants.
Verified June 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01707004
First received: October 8, 2012
Last updated: June 25, 2013
Last verified: June 2013

October 8, 2012
June 25, 2013
July 2012
July 2014   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01707004 on ClinicalTrials.gov Archive Site
  • Neutrophil recovery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: neutrophil recovery.
  • Assessment of graft failure [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: Graft failure.
  • Asessment of Acute GVHD and Chronic GVHD [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: Acute graft-versus-host disease (GVHD)and chronic GVHD.
  • Incidence of infection [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: Incidence of infection.
  • Treatment-related mortality [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: Treatment-related mortality.
  • Platelet recovery [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: platelet recovery.
  • Time to relapse/progression [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: Time to relapse/progression.
  • Overall patient survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: Overall survival.
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Patients enrolled in this study will also be followed for the following endpoints: Progression-free survival.
Same as current
Not Provided
Not Provided
 
Decitabine Followed by Partially Matched Related Bone Marrow Transplant for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia
Decitabine Followed by Partially Matched Related Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia.

The purpose of this study is to test the results of chemotherapy and radiation given before and after a bone marrow transplant from a partially mismatched related donor.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Procedure: Bone marrow transplant
  • Drug: Decitabine
  • Drug: Cyclophosphamide
  • Drug: Mycophenolate mofetil
  • Drug: Tacrolimus
  • Radiation: 12 Gy Total body radiation
Experimental: Decitabine, bone marrow transplant
Patients will receive decitabine 20 mg/m2 IV for 10 consecutive days. Beginning 7 - 14 days later, patients will receive 12 Gy total body radiation followed by bone marrow transplant. GVHD prophylaxis will consist of high dose cyclophosphamide, mycophenolate mofetil, and tacrolimus.
Interventions:
  • Procedure: Bone marrow transplant
  • Drug: Decitabine
  • Drug: Cyclophosphamide
  • Drug: Mycophenolate mofetil
  • Drug: Tacrolimus
  • Radiation: 12 Gy Total body radiation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
July 2016
July 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Mark B Juckett, M.D. 608-263-0338 mbj@medicine.wisc.edu
United States
 
NCT01707004
HO11421
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Mark B Juckett, M.D. University of Wisconsin, Madison
University of Wisconsin, Madison
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP