MDACC Study Summary 2006-0478

Study Summary
No. 2006-0478:.......Leukemia......Farhad Ravandi-Kashani......Leukemia

Study Summary Title



Study Summary Number:	2006-0478

Study Title:	Phase II study of combination of hyper-CVAD and dasatinib in patients with Philadelphia (Ph) chromosome positive and/or BCR-ABL positive acute lymphoblastic leukemia (ALL)

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:	N/A

Phase of Study:	Phase II	Return Visit:	Induction course will be administered at MD Anderson, thereafter patient visits will occur every 2-4 courses.

Treatment Agents:	Adriamycin Cyclophosphamide Cytarabine Dasatinib Dexamethasone Methotrexate Prednisone Solumedrol Vincristine	Home Care:	After the induction course all subsequent courses can be administered by local oncologists under the instruction and prescription of MD Anderson physician or PI of the study

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	approximately 4 or 5 days every 2 to 4 weeks. 21 to 28 days of hospitalization if the induction course is carried in the protected environment


Description/ Intervention:	The goal of this clinical research study is to find out if intensive chemotherapy combined with dasatinib, followed by maintenance therapy, can help to control ALL with the Ph chromosome and/or BCR-ABL. The safety of this treatment will also be studied.

Study Objectives / Outcomes

1. To evaluate the clinical efficacy (event-free survival) of an intensive short-term chemotherapy regimen (Hyper-CVAD program) given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia (Ph)-positive and/or BCR-ABL-positive acute lymphoblastic leukemia-ALL).

2. To evaluate other clinical efficacy (overall response rate and survival) and safety of an intensive short-term chemotherapy regimen (Hyper-CVAD program) given in combination with the tyrosine kinase inhibitor dasatinib for Philadelphia (Ph)-positive and/or BCR-ABL-positive acute lymphoblastic leukemia-ALL).

Study Status Information



Study Activation / Registration Date:	09/28/2006

IRB Review and Approval Date:	08/16/2006

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) Diagnosis of one of the following: Previously untreated Ph-positive ALL [either t(9;22) and/or bcr-abl positive] (includes patients initiated on first course of hyper-CVAD before cytogenetics known) These groups will be analyzed separately. After 1-2 courses of chemotherapy with or without imatinib mesylate (Gleevec) � If they achieved CR, they are assessable only for event-free and overall survival, or � If they failed to achieve CR, they are assessable for CR, event-free, and overall survival. Patients with relapsed Ph-positive ALL or lymphoid blast phase of CML.

2) Age greater than or equal to 18 years

3) ECOG performance status less than or equal to 2

4) Adequate liver function (bilirubin less than or equal to 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine less than or equal to 3.0 mg/dl, unless considered due to tumor)

5) Adequate cardiac function as assessed clinically.

6) Signed informed consent

Exclusion Criteria:

1) Active serious infection not controlled by oral or intravenous antibiotics

2) Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator

3) Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year

4) Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria. Uncontrolled angina, or MI within 6 months. Diagnosed or suspected congenital long QT syndrome. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes). Prolonged QTc interval on pre-entry electrocardiogram (> 470 msec). Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes (unless these can be changed to acceptable alternatives)

5) Prior history of treatment with dasatinib

6) Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.

7) History of significant bleeding disorder unrelated to cancer, including: � Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease) � Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)

8) Patients with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia

Links

Registration Number: NCT00390793
Study Information on Clinical Trials Registry (clinicaltrials.gov)