MDACC Study Summary 2010-0981

Study Summary
No. 2010-0981:.......Leukemia......Farhad Ravandi-Kashani......Leukemia

Study Summary Title



Study Summary Number:	2010-0981

Study Title:	Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) with ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)

Physician

New Patient Referral



Name:	Farhad Ravandi-Kashani	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:	713-745-0394 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	Pfizer, Inc.

Phase of Study:	Phase II	Return Visit:

Treatment Agents:	Arsenic Trioxide ATRA Gemtuzamab Ozogamicin	Home Care:

Treatment Loc:	Both at MDACC & and Other Sites

Estimated Length of Stay in Houston:


Description/ Intervention:	The goal of this clinical research study is to learn if the combination of all-trans retinoic acid (ATRA), arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) can help to control APL. The safety of this drug combination will also be studied.

Study Objectives / Outcomes

Assess whether (a) a combination of all-trans retinoic acid (ATRA), and arsenic trioxide (ATO) can produce long-term event-free survival in patients with low-risk untreated acute promyelocytic leukemia (APL); (b) administration of (GO) at the diagnosis in patients with high-risk APL (WBC > 10,000) and if the WBC rises to > 10,000 after start of treatment (in patients with low-risk disease) will improve CR rate without increasing toxicity in high-risk untreated APL.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	10/05/2011

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	100

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) A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, PCR, or POD test.

2) Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study.

3) Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/or one dose of idarubicin due to the urgency to start therapy early).

4) Patients age 10 years and older are eligible.

5) Women of child-bearing potential must have a negative serum pregnancy test at screening. In addition to having a negative pregnancy test confirmed at screening, all female participants of childbearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug.

6) All sexually active subjects (males and females of child-bearing potential) agree to use 2 effective methods of contraception for the duration of the study.

Exclusion Criteria:

1) QTc interval on the EKG greater than 480 milliseconds by any correction.

2) Patients with creatinine > 2.5 and total bilirubin >/= 2.0 and ALT/AST > 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease.

Links

Registration Number: NCT01409161
Study Information on Clinical Trials Registry (clinicaltrials.gov)