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Study Summary
No. 2011-0030:.......Leukemia......Susan O'Brien......Leukemia
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Study Summary Title
Study Summary
Number:
2011-0030
Study Title:PHASE II STUDY OF COMBINATION OF HYPER-CVAD AND PONATINIB IN PATIENTS WITH PHILADELPHIA (PH) CHROMOSOME POSITIVE AND/OR BCR-ABL POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)
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Physician New Patient Referral
Name:Susan O'BrienPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:LeukemiaReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-7543
Contact us about clinical trials
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General Information
Disease Group:LeukemiaSupported By:Ariad
Phase of Study:Phase IIReturn
Visit:
Treatment
Agents:
Adriamycin
Citrovorum
Cyclophosphamide
Cytarabine
Dexamethasone
G-CSF
Methotrexate
MESNA
Ponatinib
Prednisone
Solumedrol
Vincristine
Home Care:
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Description/
Intervention:
The goal of this clinical research study is to learn if intensive chemotherapy
combined with ponatinib, 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.
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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 ponatinib for Philadelphia (Ph)-positive and/or BCR-ABL-positive acute lymphoblastic leukemia-ALL.

2. To evaluate other clinical efficacy endpoints (overall response rate and survival) and safety of the regimen.
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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:N/A
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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: a) 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); b) Previously treated Ph-positive ALL, after 1-2 courses of chemotherapy with or without other TKIs 1) If they achieved CR, they are assessable only for event-free and overall survival, or 2) If they failed to achieve CR, they are assessable for CR, event-free, and overall survival.

2) Age >/= 18 years

3) Performance status </= 2 (ECOG Scale, Appendix E)

4) Adequate liver function (bilirubin </= 3.0 mg/dl, unless considered due to tumor), and renal function (creatinine </= 3.0 mg/dl, unless considered due to tumor)

5) Adequate cardiac function as assessed clinically by history and physical examination

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 (Appendix H); a) Uncontrolled angina, or MI within 6 months, b) Diagnosed or suspected congenital long QT syndrome, c) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes), d) Prolonged QTc interval on pre-entry electrocardiogram (> 470 msec) unless corrected after electrolyte replacement, e) 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 ponatinib

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: a) Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease), b) 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

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Links
Registration Number: NCT01424982
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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