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
  Purpose

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.


Condition Intervention Phase
Acute Myeloid Leukemia
Procedure: Bone marrow transplant
Drug: Decitabine
Drug: Cyclophosphamide
Drug: Mycophenolate mofetil
Drug: Tacrolimus
Radiation: 12 Gy Total body radiation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Decitabine Followed by Partially Matched Related Bone Marrow Transplant and High-Dose Cyclophosphamide for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia.

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Bone marrow transplant Drug: Decitabine Drug: Cyclophosphamide Drug: Mycophenolate mofetil Drug: Tacrolimus Radiation: 12 Gy Total body radiation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707004

Contacts
Contact: Mark B Juckett, M.D. 608-263-0338 mbj@medicine.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53719
Contact: Mark B Juckett, M.D.    608-263-0338    mbj@medicine.wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Mark B Juckett, M.D. University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01707004     History of Changes
Other Study ID Numbers: HO11421
Study First Received: October 8, 2012
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Relapsed
Refractory

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Cyclophosphamide
Mycophenolate mofetil
Tacrolimus
Decitabine
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Enzyme Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on April 20, 2014