Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide

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.
 
ClinicalTrials.gov Identifier: NCT00850304
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : February 24, 2009
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Brief Summary:
Our purpose in this study is to explore the feasibility of treatment of non promyelocytic Acute myeloid leukaemia on elderly patients. We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Drug: Cytosar Drug: Arsenic trioxide Phase 2

Detailed Description:

Acute myeloid leukemia is a disease in which characterised by blast further than 20% in bone marrow plus incomplete differentiation. Many of this patients are elderly with age further than 60 years(CALGB,ECOG,EORTC) or 55 years (SWOG). Mortality rate fallowing standard therapy of this patients is high that can reach to 50%. One of methods to apply a remission with least mortality and morbidity and also significant lower cost effects compare to historical and conventional standard regimen is low dose cytosar and arsenic trioxide combination that has been reported complete remission to 34%.

We select ten patients with age further than 60 with comorbidity and treat by low dose cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival in end of one year.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility Study of Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide on Ambulatory Schedule
Study Start Date : October 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008


Arm Intervention/treatment
Experimental: Arm one Drug: Cytosar
Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle

Drug: Arsenic trioxide
Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11
Other Name: ATO




Primary Outcome Measures :
  1. Response Rate [ Time Frame: 1, 2, 6 month and one year after intervention ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: One year after intervention ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elderly patients with non promyelocytic AML
  • Performance status (ECOG) 3 or 4

Exclusion Criteria:

  • Age <60 years
  • Elevation of AST OR ALT more than ten times above normal
  • Serum bilirubin above 5
  • Cr level > 2

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 ClinicalTrials.gov identifier (NCT number): NCT00850304


Locations
Layout table for location information
Iran, Islamic Republic of
Hematology-Oncology and SCT Research Center
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Layout table for investigator information
Study Director: Kamran Alimoghaddam, M.D. Hematology-Oncology and SCT Research Center

Layout table for additonal information
Responsible Party: Mahdi Jalili M.D., Hematology-Oncology and SCT Research Center
ClinicalTrials.gov Identifier: NCT00850304    
Other Study ID Numbers: 87-02-36-7242
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: February 24, 2009
Last Verified: February 2009
Keywords provided by Tehran University of Medical Sciences:
AML
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Arsenic Trioxide
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs