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Decitabine, Cytarabine, GCSF for Refractory AML/MDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00740181
Recruitment Status : Terminated (Lack of efficacy)
First Posted : August 22, 2008
Results First Posted : July 2, 2013
Last Update Posted : August 1, 2014
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Information provided by (Responsible Party):
James Butera, Brown University

Brief Summary:
This study will determine the activity of decitabine, low dose cytarabine (ARA-C) and G-CSF for patients with myelodysplasia and leukemia.

Condition or disease Intervention/treatment Phase
Myelodysplasia Leukemia Drug: chemotherapy Phase 2

Detailed Description:
The primary objective of this study is to determine the feasibility and toxicity of decitabine, ARA-C and G-CSF for patients with myelodysplasia, refractory acute leukemia and poor performance status acute leukemia.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study With Decitabine, Low Dose Cytarabine and G-CSF in High-risk Myelodysplastic Syndromes, Refractory Acute Myeloid Leukemia or Acute Myeloid Leukemia in Patients With Significant Co-morbidities.
Study Start Date : August 2008
Primary Completion Date : February 2010
Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: Chemotherapy
Decitabine 20 mg/m2 IV over 1 hr days 1-5 Cytarabine 20 mg/m2 subcut days 1-5 G-CSF 5mcg/kg subcut days 1-5
Drug: chemotherapy

Primary Outcome Measures :
  1. Response Rate [ Time Frame: within 30 days of last treatment ]

    Complete Response/Complete Remission:

    Complete remission (CR) is defined as the presence of all of the following:

    • Peripheral blood - No leukemic blasts present.
    • No extramedullary findings of leukemia or disappearance of such (i.e. CNS or soft tissue involvement)
    • Bone marrow
    • No Auer rods
    • Less than 5% blast cells.
    • CBC and bone marrow criteria must be met within one week of each other.
    • Hemoglobin 9g/dl or greater
    • Neutrophil count >1000 and platelet count >100,000.
    • RBC Transfusion free for 2 weeks.

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients must have histological confirmation of disease prior to enrollment on study.
  • Patients with de novo AML who are not eligible for induction chemotherapy are eligible. Patients with refractory, relapsed AML are eligible.
  • Patients with AML evolving from prior MDS or secondary to prior chemotherapy are eligible provided they are not eligible for standard induction chemotherapy.
  • Patients with MDS and with blasts > 10% (RAEB-II) are eligible.
  • Patients with extramedullary relapse only (i.e., leukemia cutis or other extramedullary site) are eligible as long as disease can be monitored.
  • Patients who have relapsed after standard autologous and/or allogeneic bone marrow transplant are eligible as long as they meet all other eligibility criteria.
  • Patients must not have had any chemotherapy, except hydrea, or radiation for at least 4 weeks prior.
  • Patients must be > 18 years of age.
  • Patients with an active second malignancy other than non-melanoma skin cancers are not eligible.
  • Patients must have an expected life expectancy of > 12 weeks at the time of enrollment.
  • Patients with visceral, blood stream or nervous system opportunistic infection are eligible if the infection has been appropriately treated and controlled. Patients with fungal lung infections must have had treatment for at least one month and have proof of regression prior to enrollment. Patients may be on antimicrobials at the time of therapy.
  • Initial required laboratory values:

    • Total Bilirubin < 2 X upper limit of normal.
    • AST & ALT < 3 X upper limit of normal (if elevated liver enzymes thought likely due to Leukemic infiltrate discuss with the Principal Investigator and the BrUOG Central Office).
    • Creatinine < 2 mg/dl.
    • < 15,000 K/uI blast count—Hydroxyurea can be used to decrease count if more than 15,000 K/ul.
  • Patients must have an ECOG performance status of 0-2.
  • Patients must receive and sign a full informed consent.
  • Patients should not have co-existing medical illnesses which would limit survival < 12 weeks.
  • No known history of HIV.
  • The safety of decitabine in human pregnancy is unknown. Based on animal studies, decitabine may cause fetal harm when administered to a pregnant woman. Therefore, it is important that you do not become pregnant or father a child while receiving study medication and for 2 months afterwards because the drugs in this study may affect an unborn baby.
  • If you are a woman capable of becoming pregnant (not surgically sterile or post-menopausal), you must have a negative pregnancy test before beginning treatment.

If you do become pregnant, suspect you are pregnant, or if your partner becomes pregnant while you are on this study, you must notify your study doctor immediately. If you become pregnant, you will be taken off this study.

In addition, you must not breast feed at any time you are on this study since any drugs you are taking may also affect the child.

If you are capable of giving birth to or fathering a child, you must agree to use a form of birth control (examples of effective birth control are: a condom or a diaphragm with spermicidal jelly; oral, injectable, or implanted birth control; or abstinence) that is medically acceptable to your study doctor while taking part in this research study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00740181

United States, Rhode Island
Lifespan Hospitals
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Brown University
Memorial Hospital of Rhode Island
Roger Williams Medical Center
Principal Investigator: James Butera Brown University

Responsible Party: James Butera, Prinicipal Investigator, Brown University Identifier: NCT00740181     History of Changes
Other Study ID Numbers: BrUOG-AML-217
MGI Pharma#DAC 022/2007 ( Other Identifier: Brown University )
First Posted: August 22, 2008    Key Record Dates
Results First Posted: July 2, 2013
Last Update Posted: August 1, 2014
Last Verified: July 2014

Keywords provided by James Butera, Brown University:
refractory leukemia
acute leukemia

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors