Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-risk Myelodysplastic Syndrome

NCT00968071 | Completed Phase 2 Results

• 1 other identifier: 2007-0882
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) 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.

Conditions

Acute Myelogenous Leukemia; Myelodysplastic Syndrome

Keywords

Leukemia; AML; MDS; High-Risk Myelodysplastic Syndrome; Decitabine; 5-aza-2 deoxycytidine; Dacogen; Gemtuzumab Ozogamicin; Mylotarg

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Response (CR)

  Complete Response (CR) was defined as normalization of peripheral blood and bone marrow with \</= 5% blasts, a peripheral anc \>/= 1 \* 10\^9 /l, and a platelet count of \>/= 100 \& 10\^9 /l. Evaluation after each treatment course (5-6 weeks) up to 6 cycles.

  Up to 36 weeks

Study Arms (1)

Decitabine + Gemtuzumab Ozogamicin

EXPERIMENTAL

Decitabine 20 mg/m\^2 intravenously (IV) over an hour and half daily for 5 days, Gemtuzumab Ozogamicin 3 mg/m\^2 IV on day 5.

Drug: Decitabine; Drug: Gemtuzumab Ozogamicin

Interventions

Decitabine DRUG

20 mg/m\^2 IV over an hour and half daily for 5 days.

Also known as: Dacogen

Decitabine + Gemtuzumab Ozogamicin

Gemtuzumab Ozogamicin DRUG

3 mg/m\^2 IV on day 5.

Also known as: Gemtuzumab, Mylotarg

Decitabine + Gemtuzumab Ozogamicin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age \>/= to 16 years at the time of signing the informed consent form.
• Diagnosis of Acute myeloid leukemia (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 International Prognostic Scoring System (IPSS) or \>/= to 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).
• Eastern Cooperative Oncology Group (ECOG) performance status of \</= to 3 at study entry.
• Laboratory test results within these ranges (unless due to leukemia): Serum creatinine \</= 2 mg/dL Total bilirubin \</= 2 mg/dL aspartate aminotransferase (AST) (SGOT) and/or alanine aminotransferase (ALT) (SGPT) \</= 2.5 x ULN or \</= 5 times Upper limit of normal (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.

You may not qualify if:

• 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 7 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Leukemia

Interventions

Decitabine; Gemtuzumab

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Calicheamicins; Aminoglycosides; Glycosides; Carbohydrates; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Gautam Borthakur M.D./Associate Proffesor
• Organization: The University of Texas M. D. Anderson Cancer Center

eharriso@mdanderson.org

713-563-1586

Study Officials

• Gautam Borthakur, MBBS

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 28, 2009
• Study Start: February 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 8, 2013
• Results First Posted: March 8, 2013

Record last verified: 2013-02

Locations

US (1)