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.

A phase II study to evaluate the role of short-course Pomalidomide in maintaining treatment-free remission post tyrosine-kinase inhibitor (TKI) discontinuation in adult patients with chronic myeloid leukemia-chronic phase (CML-CP). - REFLECT CML

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028549

Enrollment

110

Registered

2020-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Pomalidomide: Pomalidomide for a period of 6 months will increase the 12-month molecular relapse free survival (mRFS) by 10 %( hence prevent haematological relapse). Pomalidomide has a

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. To study the 12-month molecular relapse free survival. Timepoint: 12 months	—

Secondary

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

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr Avinash Bonda

Tata Memorial Hospital

avinash.bvn@gmail.com24177000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026