MDACC Study Summary 2006-0706

Study Summary
No. 2006-0706:.......Leukemia......Farhad Ravandi-Kashani......Leukemia

Study Summary Title



Study Summary Number:	2006-0706

Study Title:	Treatment of APL with all-trans retinoic acid, and arsenic +/- gemtuzumab

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:	713-792-7305 Contact us about clinical trials

General Information



Disease Group:	Leukemia	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Twice weekly for 1 month, then every 3 - 6 months.

Treatment Agents:	Arsenic Trioxide ATRA	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if starting arsenic trioxide (ATO) therapy on Day 10 rather than Day 1 is more effective in treating patients with newly-diagnosed APL. Researchers also want to learn if theophylline can help to control APL.

Study Objectives / Outcomes

Assess whether the following will improve CR rate without increasing toxicity in high-risk untreated acute promyelocytic leukemia (APL):
1) initiation of arsenic trioxide (ATO) on day 1, rather than day 10, of therapy,
and
2) administration of gemtuzumab ozogamycin (GO) if the WBC rises to > 10,000 after start of treatment at the descretion of the treating physician

Study Status Information



Study Activation / Registration Date:	12/05/2006

IRB Review and Approval Date:	10/18/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

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) A diagnosis of APL based on the presence of the PML-RAR alpha fusion gene. Documentation can be done either cytogenetically (the t (15;17) is found, as a consequence of the formation of the fusion gene) or molecularly (PCR test for t (15;17), or a positive "POD" test (12).

2) Provision of written informed consent.

Exclusion Criteria:

1) Cannot be in first trimester of pregnancy (ATRA is teratogenic)

2) QTC interval must not be greater than 480 milliseconds.

3) Taking any drugs known to prolong the QT interval. Any patient taking them who has a baseline heart rate of less than 60 beats per minute at rest would have an EKG to evaluate for QTc prolongation, if the QTc is above the limit of 480 msec then the patient would be given an option to be evaluated by cardiology.

Links

Registration Number: NCT00413166
Study Information on Clinical Trials Registry (clinicaltrials.gov)