This is a study in blood cancer patients. We will try a new approach to make the patients treatment free.This research will try to find out how much a medicine called Pomalidomide is helpful in this method.

Phase 2

• Conditions: Health Condition 1: C921- Chronic myeloid leukemia, BCR/ABL-positive

• Registration Number: CTRI/2020/10/028549
• Lead Sponsor: TRAC TMC Research Administrative Council

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Age more than or equal to 18years.

2. CML Chronic phase.

3. Duration of all TKI more than or equal to 3 yrs.

5. BCR-ABL transcript identified as e13a2 or e14a2.

6. Patients willing for regular follow up.

7. Following laboratory values at the time of enrolment to the intervention phase:

8. Women of reproductive age are using effective contraception, are not pregnant and agree

not to become pregnant during participation in the trial. Men agree not to father a child while

on Pomalidomide and till 4 weeks after stopping Pomalidomide

Exclusion Criteria

1.Patients who had warning response or failure with TKI at 6 months or beyond the initiation

of TKI, as per the ELN 2013 guidelines .

2. Patients with past history of coronary artery disease, CVA, or thrombotic tendencies.

3. Uncontrolled Diabetes mellitus.

4. Non-compliance to TKI for more than 1month at any time point.

5.Subject has a history of malignancy within 3 years before the date of enrolment (exceptions

are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or

malignancy that in the opinion of the investigator, is considered cured with minimal risk of

recurrence within 3 years).

6. Intolerance or allergy to Aspirin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To study the 12-month molecular relapse free survival. <br/ ><br>Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
1. Time to molecular relapse- analysed using Kaplan-Meier method. <br/ ><br>2. Overall survival and Progression free survival- analysed using Kaplan-Meier method. <br/ ><br>3. Toxicities attributable to Pomalidomide-summarised using descriptive statistics. <br/ ><br>4. Quality of life measurement.Timepoint: 1. Time to molecular relapse at last of follow up till loss of MMR or at 24 months <br/ ><br>2. PFS and OS at 24 months. <br/ ><br>3. Quality of life at- 6 months, 12 months, 18 months, 24 months.