MDACC Study Summary 2007-0882

Study Summary
No. 2007-0882:.......Leukemia......Gautam Borthakur......Leukemia

Study Summary Title



Study Summary Number:	2007-0882

Study Title:	A Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome

Physician

New Patient Referral



Name:	Gautam Borthakur	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Leukemia	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-1586 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	1-3 months

Treatment Agents:	Decitabine Gemtuzamab Ozogamicin	Home Care:	Post induction cycles as well as supportive care can be administered at a local oncologists office.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Since the treatment can be administered as out-patient we do not expect hospitalization unless required for other reasons


Description/ Intervention:	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.

Study Objectives / Outcomes

Primary:
1) Evaluate the complete remission rates achieved in patients with acute myelogenous leukemia and MDS with a regimen incorporating decitabine and gemtuzumab ozogamicin.
Secondary:
1) Evaluate the safety of the regimen
2) Assess the rates of other clinically relevant responses
3) Durability of responses
4) Event free survival and overall survival

Study Status Information



Study Activation / Registration Date:	02/19/2008

IRB Review and Approval Date:	02/19/2008

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Understand and voluntarily sign an informed consent form.

2) Age >/= to 16 years at the time of signing the informed consent form.

3) 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 >/= 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).

4) ECOG performance status of </= to 3 at study entry.

5) 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

6) 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:

1) Pregnant or breastfeeding females.

2) Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk.

3) Use of any other experimental drug or therapy for leukemia within 7 days unless there is clear evidence of rapid disease progression.

4) 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).

Links

Registration Number: NCT00968071
Study Information on Clinical Trials Registry (clinicaltrials.gov)