Full Text View
Tabular View
No Study Results Posted
Related Studies
Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (H-R MDS)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, April 2009
First Received: April 15, 2009   No Changes Posted
Sponsors and Collaborators: M.D. Anderson Cancer Center
Eisai Inc.
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00882102
  Purpose

The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine) given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.


Condition Intervention Phase
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Drug: Decitabine
Drug: Gemtuzumab ozogamicin
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood
Drug Information available for: Gemtuzumab ozogamicin 5-Aza-2'-deoxycytidine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Evaluate the complete remission rates achieved in patients with acute myelogenous leukemia and MDS with a regimen incorporating decitabine and gemtuzumab ozogamicin. [ Time Frame: April 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety of the regimen. [ Time Frame: April 2012 ] [ Designated as safety issue: Yes ]
  • Assess the rates of other clinically relevant responses. [ Time Frame: April 2012 ] [ Designated as safety issue: Yes ]
  • Durability of responses. [ Time Frame: April 2012 ] [ Designated as safety issue: Yes ]
  • Event free survival [ Time Frame: April 2012 ] [ Designated as safety issue: Yes ]
  • Overall survival. [ Time Frame: April 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Decitabine + Gemtuzumab Ozogamicin
Drug: Decitabine
Decitabine 20 mg/m2 IV over 1-1/2 hours daily x 5.
Drug: Gemtuzumab ozogamicin
Gemtuzumab ozogamicin 3 mg/m2 IV on day 5.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Understand and voluntarily sign an informed consent form.
  • Age >/= to 16 years at the time of signing the informed consent form.
  • Diagnosis of AML [other than acute promyelocytic leukemia (APL)] with refractory/relapsed disease. Patients with newly diagnosed AML will be eligible if not a candidate for intensive chemotherapy. Patients with high-risk (intermediate-2 or high by IPSS or >/= 10% blasts) MDS will also be eligible. All non-hematological toxicity of previous cancer therapy should have resolved to </= grade 1 (except alopecia or other toxicities not involving major organs).
  • ECOG performance status of </=3 at study entry.
  • Laboratory test results within these ranges (unless due to leukemia): Serum creatinine </= 2 mg/dL Total bilirubin </= 2 mg/dL AST (SGOT) and/or ALT (SGPT) </= 2.5 x ULN or </= 5 x ULN if related to disease
  • Women of childbearing potential (WCBP) must have a negative urine pregnancy test within 7 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partner's vasectomy, hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.

Exclusion Criteria:

  • Pregnant or breastfeeding females.
  • Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk.
  • Use of any other experimental drug or therapy for leukemia within 14 days unless there is clear evidence of rapid disease progression.
  • Use of hydrea to control proliferative disease will be allowed prior to starting therapy on study and for up to 7 days each during cycle 1-3 (Maximum daily dose of 7gm).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00882102

Contacts
Contact: Gautam Borthakur, M.D. 713/563-1586 gborthak@mdanderson.org

Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Gautam Borthakur, M.D.     713-563-1586     gborthak@mdanderson.org    
Principal Investigator: Gautam Borthakur, M.D.            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Investigators
Principal Investigator: Gautam Borthakur, M.D. M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: The University of Texas M.D. Anderson Cancer Center ( Gautam Borthakur M.D./ Assistant Professor )
Study ID Numbers: 2008-0288
Study First Received: April 15, 2009
Last Updated: April 15, 2009
ClinicalTrials.gov Identifier: NCT00882102     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Acute Myelogenous Leukemia
High-Risk Myelodysplastic Syndrome
AML
MDS
Leukemia
Decitabine
Gemtuzumab Ozogamicin
Dacogen
Mylotarg

Study placed in the following topic categories:
Antimetabolites
Immunologic Factors
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Leukemia, Myeloid
Decitabine
Leukemia, Myeloid, Acute
Gemtuzumab
Antibodies, Monoclonal
Leukemia
Preleukemia
Acute Myelocytic Leukemia
Antibodies
Acute Myeloid Leukemia, Adult
Bone Marrow Diseases
Immunoglobulins

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Precancerous Conditions
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Leukemia, Myeloid, Acute
Antibodies, Monoclonal
Leukemia
Preleukemia
Pathologic Processes
Syndrome
Therapeutic Uses
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Enzyme Inhibitors
Leukemia, Myeloid
Decitabine
Gemtuzumab
Pharmacologic Actions
Neoplasms
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 06, 2009