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An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Nilotinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)


Phase 2
55 Years
N/A
Open (Enrolling)
Both
Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia

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Trial Information

An Open Label Phase II Study to Evaluate the Efficacy and Safety of Induction and Consolidation Therapy With Nilotinib in Combination With Chemotherapy in Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)


Inclusion Criteria:



1. Male or female patients > 55 years

2. Philadelphia chromosome- or BCR-ABL positive acute lymphoblastic leukemia

3. Not previously treated except with corticosteroids or single dose vincristine (three
doses cyclophosphamide accepted)

4. With or without documented CNS involvement

5. WHO performance status < 2

6. Normal serum levels > LLN (lower limit of normal) of potassium, magnesium, total
calcium corrected for serum albumin; or corrected to within normal limits with
supplements, prior to the first dose of study medication

7. Signed written inform consent

8. Molecular evaluation for BCR-ABL performed

9. Willingness of male subjects whose sexual partners are women of child-bearing
potential (WOCBP), to use an effective form of contraception (pearl index < 1%), such
as complete sexual abstinence, combined oral contraceptive, hormone IUCD, vaginal
hormone ring, transdermal contraceptive patch, contraceptive implant or depot
contraceptive injection in combination with a second method of contraception like a
condom or a cervical cap / diaphragm with spermicide or surgical sterilisation
(vasectomy) in male patients during the study and at least 6 months thereafter. WOCBP
are defined as sexually mature women who have not undergone a hysterectomy or
surgical sterilization or who have not been naturally postmenopausal for at least 12
consecutive months (i.e., who has had menses any time in the preceding 12 consecutive
months).

Exclusion Criteria:

1. Patient previously treated with tyrosine kinase inhibitors

2. Known impaired cardiac function, including any of the following:

- LVEF < 45%

- Complete left bundle branch block

- Right bundle branch block plus left anterior hemiblock, bifascicular block

- Use of a ventricular-paced pacemaker

- Congenital long QT syndrome

- History of or presence of clinically significant ventricular or atrial
tachyarrhythmias

- Clinically significant resting bradycardia (< 50 beats per minute)

- QTcF>450 msec on screening ECG. If QTc > 450 msec and electrolytes are not
within normal ranges before nilotinib dosing, electrolytes should be corrected
and then the patient rescreened for QTcF criterion.

- Myocardial infarction with 12 months prior to starting nilotinib

- Other clinical significant heart disease (e.g. unstable angina, congestive heart
failure, uncontrolled hypertension)

3. Patients with a history of another primary malignancy that is currently clinically
significant or currently requires active intervention

4. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not
mandatory) or known infection with Hepatitis B or C

5. Treatment with any, other investigational agent or participating in another trial
within 30 days prior to entering this study

6. Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the institutional
upper limit of normal or > 5 times ULN if considered due to leukemia

7. Total bilirubin > 2 fold the institutional upper limit unless considered to be due to
organ involvement by the leukemia or to M. Gilbert / M. Meulengracht

8. Concurrent severe diseases which exclude the administration of therapy

9. Past history of acute or chronic pancreatits

10. Patients unwilling or unable to comply with the protocol.e branch block; Right bundle
branch block plus left anterior hemiblock, bifascicular block; Use of a
ventricular-paced pacemaker; congenital long QT syndrome

- History of or presence of clinically significant ventricular or atrial
tachyarrhythmias

- Clinically significant resting bradycardia (< 50 beats per minute)

- QTcF>450 msec on screening ECG. If QTc > 450 msec and electrolytes are not
within normal ranges before nilotinib dosing, electrolytes should be corrected
and then the patient rescreened for QTcF criterion.

- Myocardial infarction with 12 months prior to starting nilotinib

- Other clinical significant heart disease (e.g. unstable angina, congestive heart
failure, uncontrolled hypertension)

- Patients with a history of another primary malignancy that is currently
clinically significant or currently requires active intervention

- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV
testing is not mandatory) or known infection with Hepatitis B or C

- Treatment with any, other investigational agent or participating in another
trial within 30 days prior to entering this study

- Inadequate hepatic functions defined as ASAT or ALAT > 2,5 times the
institutional upper limit of normal or > 5 times ULN if considered due to
leukemia

- Total bilirubin > 2 fold the institutional upper limit unless considered to
be due to organ involvement by the leukemia or to M. Gilbert / M.
Meulengracht

- Concurrent severe diseases which exclude the administration of therapy

- Past history of acute or chronic pancreatits

- Patients unwilling or unable to comply with the protocol.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of efficacy of a nilotinib-based induction and consolidation therapy

Outcome Description:

rate of patients without event

Outcome Time Frame:

after 12 months

Safety Issue:

No

Principal Investigator

Oliver G. Ottmann, Prof.Dr.med

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johann Wolfgang Goethe University Hospitals

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EWALL-PH-02

NCT ID:

NCT01528085

Start Date:

January 2012

Completion Date:

January 2015

Related Keywords:

  • Philadelphia Chromsome Positive Acute Lymphoblastic Leukemia
  • Philadelphia chromsome
  • BCR-ABL
  • ALL
  • acute lymphoblastic leukemia
  • Nilotinib
  • Tasigna
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Philadelphia Chromosome

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