A multi-centric post marketing study to evaluate the efficacy and safety of Imatinib in patients with Chronic Myelogenous Leukemia Chronic Phase (CML- CP).

Phase 4

Completed

Conditions: Health Condition 1: null- Newly diagnosed and previously untreated BCR-ABL positive Chronic Myelogenous Leukemia Chronic Phase (CML- CP).

Registration Number: CTRI/2011/091/000249

Lead Sponsor: Cipla Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

1.Provided IEC/IRB approved written informed consent

2.Newly diagnosed and previously untreated BCR-ABL positive CML.

3.Hematological and molecular diagnosis of BCR-ABL positive CML.

4.Must be in chronic phase (CP) ( all five criteria must be fulfilled )

i.Less than 15% blasts in peripheral blood and bone marrow

ii.Less than 30% blasts + promyelocytes in peripheral blood or bone marrow

iii.Less than 20% basophils in peripheral blood

iv.Greater than 100 x 109/L platelets

v.No extramedullary involvement other than spleen or liver

5.ECOG Performance Scale of Less than or equal to 2

6.Life expectancy greater than 12 months as determined by the Investigator

Exclusion Criteria

1. Patients with BCR-ABL negative CML.

2. Patients who are in CML-accelerated phase (CML-AP) or CML-blast phase (CML-BP) during initial presentation.

3. Patients with severe renal and hepatic impairment. (creatine 2mgs/dl; liver enzymes and bilirubin 2.5 times ULN ; alkaline phosphatase 1.5 times ULN

4. Patients with congestive cardiac failure.

5. Patients who are HIV positive

6. Patients who have a tendency of fluid retention and edema

7. Patient who are on other concurrent anti cancer agents.

8. Pregnant and lactating women

9. Women of child bearing potential not using contraceptives

10. Patients on drugs which induce/inhibit CYP3A metabolism,CYP2D6 metabolism

11. Patients have been on any Investigational medicine within 30 days from screening

12. Any condition that, in the opinion of the investigator, does not justify the patients inclusion with the study