Study of deeper responses in newly diagnosed blood cancer (chronic myeloid leukemia) disease patients

Phase 3

Completed

• Conditions: Health Condition 1: null- Chronic Myeloid Leukemia

• Registration Number: CTRI/2012/10/003047
• Lead Sponsor: ovartis Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Male or female patients age more than or equal to 18 years old;

2. Patients with CML-CP within 6 months of diagnosis (date of initial diagnosis is the date

of first cytogenetic analysis). Standard conventional cytogenetic analysis must be done on

bone marrow. FISH cannot be used.

3. Diagnosis of Chronic Myeloid leukemia in Chronic Phase (CML-CP) with cytogenetic

confirmation for the presence of Philadelphia chromosome (9;22 translocation); less than

20 metaphases may be used for diagnosis;

4. Patients who are considered Ph negative because they do not have a confirmed cytogenetic

diagnosis of Philadelphia chromosome are eligible if they have no Ph+ chromosome (9;22

translocation) in more than or equal to 20 metaphases and are positive for BCR-ABL transcripts by PCR;

5. Patients with atypical BCR-ABL transcripts are eligible (transcripts other than b2a2 and

b3a2);

6. No previous treatment with any antileukemic drugs with the exception of hydroxyurea

(HU), and/or anagrelide. In emergent cases where the patient requires disease

management while awaiting study start, commercial supplies of Gleevec/Glivec at any

dose may be prescribed to the patient but for no longer than 2 weeks in duration;

7. ECOG 0,1 or 2;

8. Normal serum levels more than LLN (lower limit of normal) or corrected to within normal limits

with supplements, prior to the first dose of study medication, of potassium, magnesium

and calcium;

9. AST and ALT more than or equal to 2.5 x ULN or more than or equal to 5.0 x ULN if considered due to leukemia;

10. Alkaline phosphatase more than or equal to 2.5 x ULN unless considered due to leukemia;

11. Total bilirubin more than or equal to 1.5 x ULN;

12. Serum lipase and amylase more than or equal to 1.5 x ULN;

13. Written informed consent prior to any study procedures being performed.

Exclusion Criteria

Treatment with tyrosine kinase inhibitors or other antileukemic agents or treatments

(including HSCT) for longer than 2 weeks, with the exception of HU and/or anagrelide

2. Previously documented T315I mutations;

3. Uncontrolled congestive heart failure or hypertension;

4. Myocardial infarction or unstable angina pectoris within past 12 months;

5. Significant arrhythmias, including history or presence of clinically significant ventricular

or atrial tachyarrhythmias, clinically significant bradycardias, long QT syndrome and/orQTc 450 msec on screening ECG (using the QTcF formula). Patients with complete

LBBB;

6. History of confirmed acute or chronic pancreatitis;

7. Other concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or

uncontrolled infections, acute or chronic liver and renal disease) that could cause

unacceptable safety risks or compromise compliance with the protocol;

8. Impaired gastrointestinal function or GI disease that may alter the absorption of study drug

(e.g. ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption

syndrome, small bowel resection or gastric by-pass surgery);

9. Patients with another primary malignancy that is currently clinically significant or requires

active intervention;

10. Patients who are currently receiving treatment with any medications that have the

potential to prolong the QT interval and the treatment cannot be either discontinued or

switched to a different medication prior to starting study drug (See link for complete list:

http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm);

11. Patients actively receiving therapy with strong CYP3A4 inhibitors (e.g., erythromycin,

ketoconazole, itraconazole, clarithromycin, telithromycin, ritonavir, mibefradil) and the

treatment cannot be either discontinued or switched to a different medication prior to

starting study drug (See link for complete list:

http://medicine.iupui.edu/flockhart/table.htm);

12. Patients actively receiving therapy with strong CYP3A4 inducers (e.g., dexamthasone,

phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbitol, St. John¡¯s Wart)

and the treatment cannot be either discontinued or switched to a different medication prior

to starting study drug (See ling for complete list:

http://medicine.iupui.edu/flockhart/table.htm);

13. History of significant congenital or acquired bleeding disorder unrelated to cancer;

14. Patients who have undergone major surgery ¡Ü 2 weeks prior to starting study drug or who

have not recovered from side effects of such therapy;

15. Patients who are pregnant or breast feeding or adults of reproductive potential not

employing an effective method of birth control. (Women of childbearing potential must

have a negative serum pregnancy test within 48 hrs prior to administration of nilotinib).

Post menopausal women must be amenorrhoic for at least 12 months to be considered of

non-childbearing potential. Male and female patients must agree to employ an effective

barrier method of birth control throughout the study and for up to 3 months following

discontinuation of study drug;

16. Treatment with any hematopoietic colony-stimulating growth factors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate efficacy, using molecular response, of nilotinib 300 mg BID in the treatment of newly diagnosed chronic myeloid leukemia patientsTimepoint: Major molecular response defined as 0.1% international standard using RQ-PCR within 12 months of nilotinib treatment.