Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT01149408
First received: June 22, 2010
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy.

Primary: Safety and tolerability of the decitabine regimen in the post remission state.

Secondary:

  1. Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy.
  2. Overall survival

Condition Intervention Phase
Acute Myeloid Leukemia
AML
Drug: Decitabine (Dacogen)
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: A Pilot Study of Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients Who Can Tolerate Aggressive Therapy

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Primary: Safety and tolerability of the decitabine regimen in the post remission state. [ Time Frame: 18 mos on treatment and one year followup thereafter ] [ Designated as safety issue: Yes ]

    Patient will come to the infusion center for a one-hour infusion on three (3) consecutive days during a 28-day cycle. The 28-day cycle will be repeated for up to 18 months if tolerated or there is no evidence of loss of remission. Patient will receive maintenance therapy with the study drug Decitabine.

    The Long-Term Follow-Up Schedule begins from the end of treatment. All patients who receive at least one dose of study drug will be followed for a minimum of one year. The maximum follow-up for all patients will be 5 years from the date of last enrolled patient.



Secondary Outcome Measures:
  • 1- Disease-free survival - [ Time Frame: One Year ] [ Designated as safety issue: No ]
    To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Dectiabine as post-consolidation maintenance therapy.


Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: All patients
All participants enrolled.
Drug: Decitabine (Dacogen)
Decitabine; 20 mg/m2; 1 hour intravenous infusion; 1 -3 days (will be given on a 28-day cycle for up to 18 months)
Other Name: Dacogen (NDA 021790)

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  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with AML (excluding Acute Promyelocytic Leukemia) according to the WHO classification, including de novo and secondary AML. Patient must be in complete remission after 1 cycle of induction therapy consisting of cytarabine (100 mg/m2 as a 24 hour infusion for 7 consecutive days) and idarubicin (12 mg/m2 as a slow intravenous push daily for 3 days), and 2 cycles of consolidation therapy (each consisting of cytarabine at a dose of 1 g/m2 given intravenously over 3 hours every 12 hours on days 1,3,and 5).
  2. Patients who maintain morphologic complete remission as documented by a bone marrow aspirate/biopsy after consolidation therapy will be eligible to receive Decitabine maintenance therapy. Maintenance therapy should be started as soon as feasible after recovery from the last consolidation cycle but no sooner than 29 days after start of the last consolidation cycle and no later than 60 days after recovery from the last cycle of consolidation therapy.
  3. Age ≥ 60 years
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  5. Informed consent, personally signed and dated to participate in the study
  6. Be able to comply with study procedures and follow-up examinations
  7. Be non-fertile or agree to use birth control during the study through the end of last treatment visit
  8. Adequate renal and hepatic function as indicated by all of the following: Total bilirubin ≤ 1.5 institutional Upper Limit of Normal (ULN); and Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN; and Serum creatinine ≤ 1.5 mg/dL
  9. Adequate cardiac function as measured by at least 1 of the following: Left ventricular ejection fraction (LVEF) ≥ 50% on multigated acquisition (MUGA) scan, similar radionuclide angiographic scan, or echocardiogram

Exclusion Criteria:

  1. Diagnosis of acute promyelocytic leukemia (APL, WHO classification of APL with t(15;17)(q22;q12)
  2. Prior diagnosis and treatment for AML, including hematopoietic stem cell transplant (HSCT)
  3. Previous therapy with a hypomethylating agent including decitabine or azacitidine (i.e. for an antecedent myelodysplastic syndrome)
  4. Any prior therapy for AML except for hydroxyurea for the control of blood counts
  5. Psychiatric disorders that would interfere with consent, study participation, or follow-up
  6. Cardiac Disease: Heart failure NYHA class 3 or 4; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
  7. Chronically impaired renal function (creatinine clearance < 30 ml / min)
  8. Inadequate liver function (ALT and AST ≥ 2.5 x ULN) if not caused by leukemic infiltration
  9. Total bilirubin ≥ 1.5 x ULN if not caused by leukemic infiltration
  10. Known HIV and/or hepatitis C infection
  11. Evidence or history of severe non-leukemia associated bleeding diathesis or coagulopathy
  12. Evidence or recent history of CNS disease, including primary or metastatic brain tumors, seizure disorders
  13. Clinical evidence suggestive of central nervous system (CNS) involvement with leukemia unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal fluid (CSF)
  14. Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo therapy on this protocol
  15. Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)
  16. Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
  17. History of organ allograft
  18. Any severe concomitant condition, which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
  19. Patients who have an indication for and can undergo a non-myeloablative transplant procedure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149408

Locations
United States, Utah
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Eisai Inc.
Investigators
Principal Investigator: Paul J Shami, MD University of Utah
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT01149408     History of Changes
Other Study ID Numbers: HCI42887
Study First Received: June 22, 2010
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
AML
Decitabine
Acute Myeloid Leukemia
Elderly Patients
Cancer

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014