Health Condition 1: null- Newly diagnosed and previously untreated BCR-ABL positive Chronic Myelogenous Leukemia Chronic Phase (CML- CP).
Conditions
Interventions
Intervention1: Imatinib Tablet: 400 mg/day for a period of 6 months
Control Intervention1: NIL: NIL
Sponsors
Cipla Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Complete hematological response(CHR)Timepoint: At the end of 3 & 6 months;1. Complete hematological response(CHR)Timepoint: At the end of 3 & 6 months;1. Complete hematological response(CHR)Timepoint: At the end of 3 & 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete hemogram, blood chemistry will be done at baseline, visit 3, 3rd and 6th month and ECOG Performance Status will be done during every visit. 2. Abdomen Ultrasonography (USG) and ECG will be done at base line, 3rd and 6th month. 3. Toxicities encountered will be graded as per (Common Terminology Criteria for Adverse Events ) CTCAE Version 4Timepoint: At baseline, visit 3, 3rd and 6th month;1. RTq-PCR (Real time quantitative Polymerase Chain Reaction) testing for Molecular response (evaluation will be done at 6th month or at the end of the study in patients who have shown a hematological response.Timepoint: At the end of 6 months;2. Molecular response criteria is: i. Complete: transcript is non quantifiable and non detectable ii. Major: < 0.10 ratio for BCR-ABL: standardized control gene. Timepoint: At the end of 6 months | — |
Countries
India
Contacts
Public ContactDr Subramanian Sundaram
Lotus Clinical Research Academy Pvt. Ltd.
Outcome results
None listed